Medtronic, Inc.
Deland, FL, US
Medtronic, Inc. appears in FDA device records in Deland, FL. FDA records list 1,525 510(k) clearances between and , 7,911 PMA records and 40 registered establishments. As of , FDA records show 2,578 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
44 namesFDA records resolved to Medtronic, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Allegiance Healthcare Corporation510(k), recall
- Barrx Medical, Inc.510(k), recall
- Cardinal Health 200, LLCregistration, 510(k), enforcement report, recall
- Cardinal Health K.K.registration, 510(k), enforcement report, recall
- Cardinal Health NeuroCare Divisionrecall
- Cardinal Health,Medical Products and Services510(k), enforcement report, recall
- Carefusion 209, Inc.510(k), recall
- Carefusion 2200, Inc.registration, 510(k), enforcement report, recall
- Covidien LLCregistration, 510(k), PMA, enforcement report, recall
- Covidien LLC dba Uni-Patchenforcement report, recall
- Covidien LP (formerly Nellcor Puritan Bennett Inc.)enforcement report, recall
- COVIDIEN MEDTRONICenforcement report, recall
- Ev3 Neurovascular510(k), PMA, recall
- ev3, Inc.registration
- Fox Hollow Technologies510(k), recall
- Kendall a Division of Tyco Healthcare Group LPrecall
- Kendall Healthcare Products Corecall
- Kyphon, Inc.510(k), recall
- Medtronic Ave, Inc.510(k), recall
- Medtronic CardioVascularrecall
- Medtronic formerly Covidienenforcement report, recall
- Medtronic Inc. Cardiac Rhythm Disease Managementenforcement report, recall
- Medtronic Inc. Cardiac Rhythm Disease Managmentrecall
- Medtronic Inc. Cardiac Rhythm Managmentrecall
- Medtronic Inc., Cardiac Rhythm and Heart Failureenforcement report, recall
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)enforcement report, recall
- Medtronic Minimally Invasive Therapies Groupenforcement report, recall
- Medtronic Minimed, Inc.registration, 510(k), PMA, enforcement report, recall
- Medtronic Spine LLC, formerly Kyphon Increcall
- Medtronic Vascular, Inc.registration, 510(k), PMA, enforcement report, recall
- Medtronic,Inc/Rice Creek Facilrecall
- Micro Therapeutics Inc Dba Ev3 Neurovascularregistration, 510(k), enforcement report, recall
- Micro Therapeutics, Inc.510(k), enforcement report, recall
- Natus Neurology Incenforcement report, recall
- Natus Neurology Incorporatedregistration, 510(k), enforcement report, recall
- Nellcor Puritan Bennett Inc. (dba Covidien LP)enforcement report, recall
- Nellcor Puritan Bennett, Inc.510(k), PMA, recall
- Nicolet Biomedical Div of Viasys Healthcarerecall
- Puritan-Bennett510(k), recall
- St. Francis Medical Technologies Increcall
- Superdimension, Ltd.510(k), enforcement report, recall
- Surgical Devices/Covidienrecall
- United States Surgical Corporationrecall
- Valleylab, Inc.510(k), recall
510(k) clearance history
Showing 50 of 1,525FDA records hold 1,525 510(k) clearances for Medtronic, Inc. between 1976 and 2026. The busiest year on record is 2015, with 55. The most recent is 2026, with 20.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 2 |
| 1977 | 5 |
| 1978 | 33 |
| 1979 | 30 |
| 1980 | 16 |
| 1981 | 27 |
| 1982 | 17 |
| 1983 | 13 |
| 1984 | 15 |
| 1985 | 34 |
| 1986 | 33 |
| 1987 | 29 |
| 1988 | 26 |
| 1989 | 35 |
| 1990 | 41 |
| 1991 | 46 |
| 1992 | 33 |
| 1993 | 25 |
| 1994 | 34 |
| 1995 | 30 |
| 1996 | 31 |
| 1997 | 36 |
| 1998 | 29 |
| 1999 | 39 |
| 2000 | 40 |
| 2001 | 39 |
| 2002 | 37 |
| 2003 | 47 |
| 2004 | 37 |
| 2005 | 22 |
| 2006 | 31 |
| 2007 | 23 |
| 2008 | 24 |
| 2009 | 27 |
| 2010 | 35 |
| 2011 | 28 |
| 2012 | 47 |
| 2013 | 39 |
| 2014 | 43 |
| 2015 | 55 |
| 2016 | 52 |
| 2017 | 32 |
| 2018 | 30 |
| 2019 | 25 |
| 2020 | 30 |
| 2021 | 21 |
| 2022 | 23 |
| 2023 | 24 |
| 2024 | 20 |
| 2025 | 15 |
| 2026 | 20 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260907 | BIS™ Advance pEEG Module | OLW | Substantially Equivalent | |
| K261335 | VitalFlow Set with Balance™ Biosurface | QJZ | Substantially Equivalent | |
| K261962 | SmartGuard Technology; Predictive Low Glucose Technology | QJI | Substantially Equivalent | |
| K253527 | Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple™ 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT) | GAG | Substantially Equivalent | |
| K261866 | Concerto Versa™ Detachable Coil | KRD | Substantially Equivalent | |
| K253984 | Instrument Exit Point on Touch Surgery™ Aide | SFE | Substantially Equivalent | |
| K253530 | Trexon™ Monofilament Synthetic Absorbable Suture | GAM | Substantially Equivalent | |
| K253030 | Capnostream™35 Portable Respiratory Monitor (PM35MN) | CCK | Substantially Equivalent | |
| K253243 | Cardinal Health™ Poly Reinforced Surgical Gown | FYA | Substantially Equivalent | |
| K260195 | Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae | DWF | Substantially Equivalent | |
| K253743 | MiniMed Flex pump | QFG | Substantially Equivalent | |
| K253203 | Retrograde Coronary Sinus Perfusion Cannulae | DWF | Substantially Equivalent | |
| K253701 | SmartGuard Technology; Predictive Low Glucose Technology | QJI | Substantially Equivalent | |
| K253998 | Clearview Intracoronary Shunts | DWF | Substantially Equivalent | |
| K251744 | Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood Filter | DTM | Substantially Equivalent | |
| K253470 | MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894) | QFG | Substantially Equivalent | |
| K251831 | Bio-Medicus Life Support Catheter and Introducer | QHW | Substantially Equivalent | |
| K253585 | SmartGuard technology; Predictive Low Glucose technology | QJI | Substantially Equivalent | |
| K253511 | Concerto Versa™ Detachable Coil | KRD | Substantially Equivalent | |
| K253512 | MiniMed Go App | NDC | Substantially Equivalent | |
| K251313 | Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Disposable Inner Cannula XLT | JOH | Substantially Equivalent | |
| K251025 | Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049) | BZT | Substantially Equivalent | |
| K253409 | C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) | DQY | Substantially Equivalent | |
| K250725 | Hugo™ RAS System | SCV | Substantially Equivalent | |
| K250173 | Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley™ Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley™ Oral RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (115-XXOR) Shiley™ Nasal RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (119-XXNR) | BTR | Substantially Equivalent | |
| K243785 | Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye Shiley™ Tracheal Tube TaperGuard™ Cuff Reinforced with Stylet Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley™ Oral/Nasal Tracheal Tube Cuffless Reinforced | BTR | Substantially Equivalent | |
| K251217 | SmartGuard technology; Predictive Low Glucose technology | QJI | Substantially Equivalent | |
| K251032 | MiniMed 780G insulin pump | QFG | Substantially Equivalent | |
| K251258 | MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula | DWF | Substantially Equivalent | |
| K250075 | Medtronic Stedi Extra Support Guidewire | DQX | Substantially Equivalent | |
| K250199 | VitalFlow Console | QNR | Substantially Equivalent | |
| K250558 | SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315) | DQY | Substantially Equivalent | |
| K243982 | Nicolet EDX | GWF | Substantially Equivalent | |
| K243892 | Affera Integrated Mapping System | DQK | Substantially Equivalent | |
| K242705 | Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipolar Temporary Myocardial Pacing Lead (6500) | LDF | Substantially Equivalent | |
| K243495 | Natus Ultrapro S100 (982A0594) | GWF | Substantially Equivalent | |
| K243435 | Magnetic Localization Patch Kit (AFR-00021) | DQK | Substantially Equivalent | |
| K241486 | Sofsilk™ Coated Braided Silk Suture | GAP | Substantially Equivalent | |
| K242775 | InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) | NDC | Substantially Equivalent | |
| K241828 | Affera Integrated Mapping System; Impedance Localization Patch Kit | DQK | Substantially Equivalent | |
| K240880 | VitalFlow Set with Balance Biosurface | QJZ | Substantially Equivalent | |
| K240077 | Mon-a-Therm™ General Purpose Temperature Probe 400TM (90050, 90044) | FLL | Substantially Equivalent | |
| K233433 | Sphere-9Dx Diagnostic Catheter (AFR-00009) | MTD | Substantially Equivalent | |
| K241085 | Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN) | GEI | Substantially Equivalent | |
| K241622 | Extended Reservoir; MiniMed Reservoir | LZG | Substantially Equivalent | |
| K240572 | Valleylab™ SM Smoke Management Pencil with Edge™ Blade Electrode, 10’ (3m) (VSMP10); Valleylab™ SM Smoke Management Pencil with Edge™ Blade Electrode, 15’ (4.6m) (VSMP15); Valleylab™ SM Smoke Management Pencil with Edge™ Blade Electrode, 10’ (3m), Non-Sterile Bulk (VSMP10NSB); Valleylab™ SM Smoke Management Extended Nozzle (for use with 4” (100mm) electrode) (VSMEN4); Valleylab™ SM Smoke Management Extended Nozzle (for use with 6.5” (165mm) electrode) (VSMEN6) | GEI | Substantially Equivalent | |
| K241352 | Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (541B) | DTZ | Substantially Equivalent | |
| K241259 | Amplatz Goose Neck Snare Kit | MMX | Substantially Equivalent | |
| K233341 | Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410) | BTR | Substantially Equivalent | |
| K240534 | Bio-Medicus Life Support Catheter and Introducer | QHW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3011200334 | 3011200334 | CARDINAL HEALTH | 8322 Eagle Palm Drive, Riverview, FL 33578 US | 2026 | |
| 1623486 | 1623486 | CARDINAL HEALTH 200, LLC | 200 MCKNIGHT ST., Jacksonville, TX 75766 US | 2026 | |
| 1423507 | 3008002452 | CAREFUSION 2200, INC. | 75 North Fairway Drive, Vernon Hills, IL 60061 US | 2026 | and 54 more, listed in full below |
| 1625685 | 1625685 | CAREFUSION 2200, INC. | 400 East Foster Rd, Mannford, OK 74044 US | 2026 | and 1 more, listed in full below |
| 2024500 | 2024500 | COVIDIEN | 2101 Faraday Avenue, CARLSBAD, CA 92008 US | 2026 | and 6 more, listed in full below |
| 1017768 | 1017768 | Cardinal Health | 2010 E International Speedway Blvd, DELAND, FL 32724 US | 2026 | |
| 1018120 | 1018120 | Cardinal Health | 1430 Marvin Griffin Rd, AUGUSTA, GA 30906 US | 2026 | and 6 more, listed in full below |
| 1033903 | 1033903 | Cardinal Health | 525 Emerald Rd N, Greenwood, SC 29646 US | 2026 | |
| 1219103 | 1000148701 | Cardinal Health | 2 Ludlow Park Dr, CHICOPEE, MA 01022 US | 2026 | and 2 more, listed in full below |
| 1915484 | 1915484 | Cardinal Health | 1222 SHERWOOD RD., Norfolk, NE 68701 US | 2026 | and 3 more, listed in full below |
| 1921846 | 1921846 | Cardinal Health | 444 JAMES SOUTH MCDONNELL BLVD., Hazelwood, MO 63042 US | 2026 | and 156 more, listed in full below |
| 2183164 | 1000116809 | Cardinal Health | 1313 WEST GRANT BLVD., Wabasha, MN 55981 US | 2026 | and 1 more, listed in full below |
| 1423537 | 3001236905 | Cardinal Health 200, LLC | 3651 Birchwood Drive, Waukegan, IL 60085 US | 2026 | and 482 more, listed in full below |
| 3007329020 | 3007329020 | Cardinal Health 200, LLC | 1320 Don Haskins, El Paso, TX 79936 US | 2026 | and 219 more, listed in full below |
| 3012341425 | 3012341425 | Cardinal Health K.K. | 3033 MOROI, FUKUROI Shizuoka 437-1121 JP | 2026 | |
| 1219930 | 1219930 | Covidien | 60 Middletown Ave, North Haven, CT 06473 US | 2026 | and 64 more, listed in full below |
| 1717344 | 1717344 | Covidien | 6044 Longbow Court, BOULDER, CO 80301 US | 2026 | and 1 more, listed in full below |
| 2647580 | 2647580 | Covidien | BUILDING 911-67, PONCE, PR 00731 US | 2026 | and 17 more, listed in full below |
| 2936999 | 2936999 | Covidien | 200 Medtronic Dr, Lafayette, CO 80026 US | 2026 | and 37 more, listed in full below |
| 3008361498 | 3008361498 | Covidien | 2800 Airwest Blvd, Suite 160, Plainfield, IN 46168 US | 2026 | |
| 3026612481 | 3026612481 | Covidien | 200 Medtronic Drive, Lafayette, CO 80026 US | 2026 | and 1 more, listed in full below |
| 8020893 | 3002807850 | Covidien | Michael Collins Road, H91 W9N4 Mervue, - Galway(County) - IE | 2026 | and 4 more, listed in full below |
| 9610849 | 3002807391 | Covidien | Boulevard Insurgentes 19030 Libramiento, TIJUANA, B.C. Mexico 22225 MX | 2026 | and 42 more, listed in full below |
| 9612501 | 3003495548 | Covidien | ZONA FRANCA DE SAN ISIDRO, - Santo Domingo - DO | 2026 | and 55 more, listed in full below |
| 9681384 | 3002807626 | Covidien | Avenue Henequen No. 1181, Ciudad Juarez Chihuahua 32573 MX | 2026 | and 14 more, listed in full below |
| 1282497 | 1282497 | Covidien LLC | 15 HAMPSHIRE STREET, MANSFIELD, MA 02048 US | 2026 | and 9 more, listed in full below |
| 3004904811 | 3004904811 | Covidien llc | 3062 Bunker Hill Lane, Santa Clara, CA 95054 US | 2026 | |
| 3004962788 | 3004962788 | Covidien llc | 161 CHESHIRE LANE, Plymouth, MN 55441 US | 2026 | and 1 more, listed in full below |
| 2032227 | 3003166194 | MEDTRONIC MINIMED | 18000 Devonshire St, NORTHRIDGE, CA 91325 US | 2026 | and 14 more, listed in full below |
| 1220452 | 1220452 | MEDTRONIC VASCULAR | 37A Cherry Hill Dr, DANVERS, MA 01923 US | 2026 | and 3 more, listed in full below |
| 2182208 | 2182208 | MEDTRONIC, INC. | 8200 Coral Sea Street NE, Mounds View, MN 55112 US | 2026 | and 36 more, listed in full below |
| 3012520654 | 3012520654 | MEDTRONIC, INC. | 880 Technology Park Drive, Billerica, MA 01821 US | 2026 | |
| 2029214 | 1000220862 | MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR | 9775 Toledo Way, Irvine, CA 92618 US | 2026 | and 9 more, listed in full below |
| 3015550451 | 3015550451 | MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR | 5290 California Avenue, Irvine, CA 92617 US | 2026 | and 7 more, listed in full below |
| 2953200 | 3001452571 | Medtronic Vascular | 3576 Unocal Pl, Santa Rosa, CA 95403 US | 2026 | |
| 3001504994 | 3001504994 | Medtronic, Inc. | 710 Medtronic Parkway, Minneapolis, MN 55432 US | 2026 | No device listings on this registration |
| 3004185781 | 3004185781 | Medtronic, Inc. | 2343 W. Medtronic Way, Tempe, AZ 85281 US | 2026 | |
| 3015544746 | 3015544746 | Medtronic, Inc. | 7000 Central Ave., N.E., Minneapolis, MN 55432 US | 2026 | |
| 3010611950 | 3010611950 | Natus Neurology Incorporated | 3150 Pleasant View Road, Middleton, WI 53562 US | 2026 | and 22 more, listed in full below |
| 2183870 | 2183870 | ev3, Inc. | 4600 Nathan Lane North, Plymouth, MN 55442 US | 2026 | and 11 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CAOAirway, Esophageal (Obturator)
- BTQAirway, Nasopharyngeal
- CAEAirway, Oropharyngeal, Anesthesiology
- CCCAnalyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling
- CCEAnalyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling
- CBZAnalyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling
- CAZAnesthesia Conduction Kit
- CACApparatus, Autotransfusion
- CBTArterial Blood Sampling Kit
- BYEAttachment, Breathing, Positive End Expiratory Pressure
- BTXBoard, Arm (With Cover), Sterile
- BTGBrush, Biopsy, Bronchoscope (Non-Rigid)
- BZCCalculator, Pulmonary Function Data
- BZMCalculator, Pulmonary Function Interpretor (Diagnostic)
- BZNCart, Emergency, Cardiopulmonary (Excluding Equipment)
- BSOCatheter, Conduction, Anesthetic
- BSYCatheters, Suction, Tracheobronchial
- CAICircuit, Breathing (W Connector, Adaptor, Y Piece)
- BTICompressor, Air, Portable
- BZLComputer, Oxygen-Uptake
- BYDCondenser, Heat And Moisture (Artificial Nose)
- BZAConnector, Airway (Extension)
- BSKCuff, Tracheal Tube, Inflatable
- CBHDevice, Fixation, Tracheal Tube
- CAHFilter, Bacterial, Breathing-Circuit
- CAXFlowmeter, Tube, Thorpe, Back-Pressure Compensated
- BWHForceps, Biopsy, Bronchoscope (Non-Rigid)
- BSZGas-Machine, Anesthesia
- CAWGenerator, Oxygen, Portable
- BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
- BTTHumidifier, Respiratory Gas, (Direct Patient Interface)
- BSJMask, Gas, Anesthetic
- BYGMask, Oxygen
- BZRMixer, Breathing Gases, Anesthesia Inhalation
- BZQMonitor, Breathing Frequency
- CAFNebulizer (Direct Patient Interface)
- BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)
- CANRegulator, Pressure, Gas Cylinder
- BRZSet, Blood Transfusion
- BZOSet, Tubing And Support, Ventilator (W Harness)
- BZGSpirometer, Diagnostic
- BZKSpirometer, Monitoring (W/Wo Alarm)
- BWFSpirometer, Therapeutic (Incentive)
- BZTStethoscope, Esophageal, With Electrical Conductors
- BXNStimulator, Nerve, Battery-Powered
- BSRStylet, Tracheal Tube
- BWNTable And Attachments, Operating-Room
- BYZTrap, Sterile Specimen
- BYYTube, Aspirating, Flexible, Connecting
- BTSTube, Bronchial (W/Wo Connector)
- BTRTube, Tracheal (W/Wo Connector)
- CBITube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
- BTOTube, Tracheostomy (W/Wo Connector)
- BYXTubing, Pressure And Accessories
- BWAUnit, Electrosurgical And Coagulation, With Accessories
- BYJUnit, Liquid-Oxygen, Portable
- CBKVentilator, Continuous, Facility Use
- BTMVentilator, Emergency, Manual (Resuscitator)
- BYTVentilator, External Body, Negative Pressure, Adult (Cuirass)
- BZDVentilator, Non-Continuous (Respirator)
Recall records
Showing 25 of 2,578| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2949-2026 | Cardinal Health Presource Kits: 1) BASIC PACK , Catalog Number: SBA73BPGCA; 2) SPINE PACK , Catalog Number: SNE11SPHKC; 3) SPINE PACK , Catalog Number: SNE11SPHKD; 4) CRANIOTOMY PACK , Catalog Number: SNE12BS01B | Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products. | Class II | Open, Classified | |
| Z-2948-2026 | Cardinal Health Presource Kits: 1) KIT, MER NEURO BACK , Catalog Number: PN33NBMYD; 2) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCH4; 3) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCH5; 4) KIT, ANT CERVICAL DISC , Catalog Number: PN41ACLA9; 5) KIT, ANT CERVICAL DISC , Catalog Number: PN41ACLA9; 6) KIT, ANT CERVICAL DISC , Catalog Number: PN41ACLAI; 7) KIT, LAMINECTOMY , Catalog Number: PN41LMB10; 8) KIT, LAMINECTOMY , Catalog Number: PN41LMB11; 9) KIT, LAMINECTOMY , Catalog Number: PN41LMB12; 10) KIT, NEURO LAMINECTOMY , Catalog Number: PN41LMBLC; 11) KIT, BAL CRANIOTOMY , Catalog Number: PNCGCRBMF; 12) KIT,LAMINECTOMY NH , Catalog Number: PNOCLNNHB; 13) KIT, NEURO LAMINECTOMY , Catalog Number: PNVMOTA235; 14) KIT, NEURO LAMINECTOMY , Catalog Number: PNVMOTA236; 15) KIT, NEURO LAMINECTOMY , Catalog Number: PNVMOTA237; 63 | Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products. | Class II | Open, Classified | |
| Z-2947-2026 | Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC27; 2) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC28; 3) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC2C; 4) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC2D; 5) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC2D; 6) KIT, IUS NASAL , Catalog Number: PECGNSBOA; 7) KIT,NASAL FENS, SW , Catalog Number: PEMHNFMHB; 8) KIT,ENT , Catalog Number: PEMIEPHP2; 9) KIT,ENT , Catalog Number: PEMIEPHP3; 10) KIT,ENT , Catalog Number: PEMIEPHPB; 11) KIT, NASAL SINUS PRESBYTERIAN , Catalog Number: PEV2CL016; 12) KIT, ENT FESS , Catalog Number: PEV2FSNYC; | Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products. | Class II | Open, Classified | |
| Z-2946-2026 | Cardinal Health Presource Kits: 1) SEPTO RHINO PACK , Catalog Number: SEN73NSKCF; 2) PACK NEURO MINOR CRANIOTOMY , Catalog Number: SNE30CNOHE; 3) NEURO MAJOR 2 PACK , Catalog Number: SNE30CRJGY; 4) NEURO PACK , Catalog Number: SNE43NEE13; 5) LAMINECTOMY PACK , Catalog Number: SNE43NEE13; 7) LAMINECTOMY PACK , Catalog Number: SNE5CLPB13; 8) PEDI SPINE ROSEVILLE , Catalog Number: SNE69PSKR4; 9) SHUNT PACK , Catalog Number: SNE7CSHY15; 10) SHUNT PACK , Catalog Number: SNE7CSHY16; 11) ENS ORTHO FUSION POSTERIEURE 3, Catalog Number: SOP30ODSCL | Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products. | Class II | Open, Classified | |
| Z-2945-2026 | Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Number: 24-0726A; 2) KIT,SINUS , Catalog Number: PE13SPAJA; 3) KIT,SINUS , Catalog Number: PE13SPAJB; 4) KIT, SINUS , Catalog Number: PE13SPAJC; 5) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number: PE13SPAJC; 6) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number: PE29NSFGP; 7) KIT, HEAD AND NECK , Catalog Number: PE33HNCR1; 8) KIT, HEAD AND NECK , Catalog Number: PE33HNCR2; 9) KIT, HEAD AND NECK , Catalog Number: PE33HNCR3; 10) KIT, HEAD AND NECK , Catalog Number: PE33HNCR4; 11) KIT, HEAD AND NECK , Catalog Number: PE33HNCRA; 12) KIT, HEAD AND NECK , Catalog Number: PE33HNCRB; 13) KIT, NASAL , Catalog Number: PE35NSB23; 14) KIT, NASAL , Catalog Number: PE35NSBLG; 15) KIT, EENT , Catalog Number: PE44EMKW8; | Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products. | Class II | Open, Classified | |
| Z-2944-2026 | Cardinal Health Presource Kits: 1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMB | Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products. | Class II | Open, Classified | |
| Z-2943-2026 | Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCC | Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products. | Class II | Open, Classified | |
| Z-2942-2026 | Cardinal Health Presource Kits: 1) FAT GRAFT ADD KIT , Catalog Number: 21-4720B; 2) TRAY FAT GRAFT ADD , Catalog Number: 21-4720C; 3) KIT,BOSC MICROLARYNGOSCOPY , Catalog Number: PECGMLBOB; 4) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAU8; 5) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAU8; 6) KIT, TRIPOINT SPINE , Catalog Number: PN1DTSLH9; 7) KIT, TRIPOINT SPINE , Catalog Number: PN1DTSLHC; 8) KIT, TRIPOINT SPINE , Catalog Number: PN1DTSLHD; 9) KIT, TRIPOINT SPINE , Catalog Number: PN1DTSLHE; 10) KIT,NEURO , Catalog Number: PN21OTMC6; 11) KIT,NEURO , Catalog Number: PN21OTMC7; 12) KIT,NEURO , Catalog Number: PN21OTMCC; 13) KIT,NEURO , Catalog Number: PN21OTMCD; 14) KIT, MER CRANI , Catalog Number: PN33CRMYB; 15) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCHB; 16) KIT, CRANIOTOMY , Catalog Number: PN40CKC27; 17) KIT, CRANIOTOMY , Catalog Number: PN40CKC28; 18) KIT, CRANIOTOMY , Catalog Number: PN40CKC29; 19) KIT, CRANIOTOMY , Catalog Number: PN40CKCFC; 20) KIT, BAL LUMBAR LAMINECTOMY , Catalog Number: PNCGLLBMB; 21) KIT, BAL LUMBAR LAMINECTOMY , Catalog Number: PNCGLLBMC; 22) BASIC PACK , Catalog Number: SBA73BPGCA; 23) FACIAL FEMINIZATION PACK , Catalog Number: SBA73FFKW9; 24) EDGECOMBE BASIC MILLER PACK , Catalog Number: SBA95BMHH6; 25) EDGECOMBE BASIC MILLER PACK , Catalog Number: SBA95BMHH7; 26) EDGECOMBE BASIC MILLER PACK , Catalog Number: SBA95BMHH8; 27) EDGECOMBE BASIC MILLER PACK , Catalog Number: SBA95BMHHF; 28) EDGECOMBE BASIC MILLER PACK , Catalog Number: SBA95BMHHG; 29) EDGECOMBE BASIC MILLER PACK , Catalog Number: SBA95BMHHH; 30) TRAM PACK , Catalog Number: SBA95TPD10; 31) TRAM PACK , Catalog Number: SBA95TPD11; 32) TRAM PACK , Catalog Number: SBA95TPDU6; 33) TRAM PACK , Catalog Number: SBA95TPDU7; 34) TRAM PACK , Catalog Number: SBA95TPDU8; 35) TRAM PACK , Catalog Number: SBA95TPDU9; 36) TRAM PACK , Catalog Number: SBA95TPDUP; 37) TRAM PACK , Catalog Number: SBA95TPDUQ; 38) PLASTIC SURGERY PACK , | Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products. | Class II | Open, Classified | |
| Z-2982-2026 | MiniMed 780G Insulin Pump, Model: MMT-1885CLW, MMT-1886CLW | Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing hypoglycemia, hyperglycemia, or diabetic ketoacidosis. | Class II | Open, Classified | |
| Z-2981-2026 | MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782; | Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing hypoglycemia, hyperglycemia, or diabetic ketoacidosis. | Class II | Open, Classified | |
| Z-2980-2026 | MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712; | Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing hypoglycemia, hyperglycemia, or diabetic ketoacidosis. | Class II | Open, Classified | |
| Z-2922-2026 | Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX | Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery. | Class II | Open, Classified | |
| Z-2921-2026 | Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623 | Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery. | Class II | Open, Classified | |
| Z-2920-2026 | Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31 DERMALON* 4-0 BLU 75CM C14 88861799-31 | Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery. | Class II | Open, Classified | |
| Z-2919-2026 | V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY PASS FINAL BOX07405V1 BOX BYPASS CARDON BOX01056V2 BOX BYPASS DR LAGAE BOX01482V2 BOX BYPASS KIT DEZEMBER 2025 BOX09222V1 BOX BYPASS KIT NEU BOX 003 BOX08767V1 BOX GASTRIC BYPASS JAWBYPASS2 BOX GASTRIC BYPASS SIGNIA BOX02191V11 BOX GASTRICBYPASS KIT V4 BOX06863V4 BOX GB BOX MET LHOOK PST04884V3 BOX GB ZONDER ENDOHERNIA EGIA PST04884V6 BOX GBP SIGNIA BOX08506V2 BOX KIT COLON IHS KIT00625V1 BOX KIT HERNIA HIATO IHS KIT01026V1 BOX LAP HERNIE INGUNIAL RIGHT BOX00051V4 BOX NEW GBP KIT PST03130V2 BOX ZESTAW DO BARIATRII GB UCKGB5 BOX ZESTAW DO RYGB WEJRYGB3 VLOCL0013 V-LOC* 180 4-0 CLR 30CM P12 VLOCL0013 VLOCL0014 V-LOC* 180 3-0 CLR 30CM P12 VLOCL0014 VLOCL0023 V-LOC* 180 4-0 CLR 45CM P12 VLOCL0023 VLOCL0024 V-LOC* 180 3-0 CLR 45CM P12 VLOCL0024 VLOCL0306 V-LOC 180 DEVICE 0 15CM GS-21 VLOCL0306 VLOCL0316 V-LOC* 180 0 GRN 30CM GS21X12 VLOCL0316 VLOCL0345 V-LOC* 180 2-0 GRN 23CM GS21 VLOCL0345 VLOCL0436 V-LOC* 180 0 GRN 60CM GS25X12 VLOCL0436 VLOCL0604 V-LOC* 180 3-0 GRN 15CM V20 VLOCL0604 VLOCL0615 V-LOC* 180 2-0 GRN 30CM V20 VLOCL0615 VLOCL0625 V-LOC* 180 2-0 GRN 45CM V20 VLOCL0625 VLOCL0644 V-LOC* 180 3-0 GRN 23CM V20 VLOCL0644 VLOCL0804 V-LOC 180 3-0 GRN 15CM CV23 VLOCL0804 VLOCL2105 V-LOC* 180 2-0 GRN 15CM GS22 VLOCL2105 VLOCL2145 V-LOC* 180 2-0 GRN 23CM GS22 VLOCL2145 VLOCL2246 VLOC180 0 GRN 9 GS-22 VLOCL2246 | Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery. | Class II | Open, Classified | |
| Z-2918-2026 | V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 VLOC 90 0 VL 22 GS-25 VLOCM0436 VLOCM0436 VLOCM0003 V-LOC* 90 4-0 CLR 15CM P12X12 VLOCM0003 VLOCM0013 V-LOC* 90 4-0 CLR 30CM P12X12 VLOCM0013 VLOCM0024 V-LOC* 90 3-0 CLR 45CM P12X12 VLOCM0024 VLOCM0123 V-LOC* 90 4-0 CLR 45CM P14X12 VLOCM0123 VLOCM0315 V-LOC* 90 2-0 VIO 30CM GS21 VLOCM0315 VLOCM0603 V-LOC* 90 4-0 VIO 15CM V20X12 VLOCM0603 VLOCM0604 V-LOC* 90 3-0 VIO 15CM V20X12 VLOCM0604 VLOCM1203 V-LOC* 90 4-0 VIO 15CM CV15 VLOCM1203 VLOCM2115 V-LOC* 90 2-0 VIO 30CM GS22 VLOCM2115 | Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery. | Class II | Open, Classified | |
| Z-2778-2026 | MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android) | For MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night is turned OFF and missed dose or Correct high glucose alerts are enabled, the associated alerts will not be triggered during the nighttime. This could result in missed rapid-acting insulin doses without the user s knowledge, and may lead to delayed therapy and an increased risk of hyperglycemia. | Class II | Open, Classified | |
| Z-2774-2026 | Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF PED2-300-20 | Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants contain 20 mm implants. | Class II | Open, Classified | |
| Z-2773-2026 | Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027 REF PED2-300-12 | Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants contain 20 mm implants. | Class II | Open, Classified | |
| Z-2698-2026 | MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896 | A software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circumstances, the pump unexpectedly stops delivering insulin and displays two error messages back-to-back: Pump Error 53 followed immediately by Pump Error 23. Insulin delivery will stop which may lead to delayed therapy and an increased risk of hyperglycemia or diabetic ketoacidosis (DKA). | Class II | Open, Classified | |
| Z-2950-2026 | EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100 ENDOFLIP 1 10884521808096 05391530810166 DL ENDOFLIP 1 10884521786684 | Due to products are incorrectly flagged as expired due to the system's 24-hour usage limit, rendering the product unavailable for clinical procedures. | Class II | Open, Classified | |
| Z-2273-2026 | Covidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 90050 | Temperature probe devices lack FDA clearance. | Class II | Open, Classified | |
| Z-2272-2026 | Covidien Mon-a-Therm General Purpose Temperature Probe REF: 90044 | Temperature probe devices lack FDA clearance. | Class II | Open, Classified | |
| Z-2271-2026 | Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 90042 | Temperature probe devices lack FDA clearance. | Class II | Open, Classified | |
| Z-2653-2026 | Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 10884522004060 Product Codes that include the Covidien Shiley Disposable Decannulation Plug are: Product Number / UDI-DI code 4DCFN 10884522006576 4DCFS 10884522006583 4DFEN 10884522006606 6DCFN 10884522006613 6DCFS 10884522006620 6DFEN 10884522006644 8DCFN 10884522006651 8DCFS 40884522006690 8DFEN 10884522006675 10DCFN 20884522006535 10DCFS 10884522006545 10DFEN 10884522006569 The Shiley Disposable Decannulation Plug (DDCP) is a universal size and fits any size DCFS, DCFN, DFEN tracheostomy tube. The red DDCP snaplock connector is used to occlude the proximal end of the outer cannula on the Shiley Tracheostomy Tubes. Refer to Table 1 for model types. The DDCP blocks airflow through the tube and directs breathing through the mouth and nose. The Shiley Tracheostomy Tube and the accessory products are intended for use in providing tracheal access for airway management. | Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP. | Class II | Open, Classified |
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