Device recalls
Recall records from FDA, newest initiation date first.
Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.
Data as of , the FDA export date. FDA medical device recall database
| Recall number | Class | Product | Recalling firm | Product code | Initiated |
|---|---|---|---|---|---|
| Z-3013-2011 | GammaMed Flexible Applicator probe; 3.2mm diameter, braced PVDF. Varian Medical Systems... | Varian Medical Systems, Inc. | JAQ | ||
| Z-3016-2011 | AirLife Nebulizer Heater, Catalog Code 2M8021 The AirLife Nebulizer Heater is part of... | Jaeger Medical GmbH | CAF | ||
| Z-1015-2012 | B. Braun Infusomat Space Pump - US Version Infusion pump. Model number 8713050U. | B Braun Medical Inc | FRN | ||
| Z-3110-2011 | Cell Marque antibody CD99 (H036-1.1) Mouse Monoclonal Antibody. Cel Marque, 6600 Sierra... | Cell Marque Corp. | NJT | ||
| Z-3044-2011 | TSRH(R) Spinal System SCREW, REF 837-645, Size: 6.5mm x 45mm, Mat'l: TITANIUM ALLOY, Rx... | Medtronic Sofamor Danek USA Inc | KWP | ||
| Z-2963-2011 | Heat Activated Niti Arches, Natural, Upper, .019x 25", Arch Wires. Packaged in 19... | G & H Wire Company | D | ||
| Z-1542-2012 | Norco Shoulder Pulley Distributed by North Coast Medical, Gilroy, CA. Used to improve... | North Coast Medical Inc | ION | ||
| Z-3263-2011 | COULTER DxH Cell Lyse, Part number 628018(1L) and 628019 (5L). The COULTER DxH Cell Lyse... | Siemens Healthcare Diagnostics Inc. | GGK | ||
| Z-2946-2011 | Vascular Solutions, Pronto V4, Extraction Catheter, Sterilized using ethylene oxide, Rx... | Vascular Solutions LLC | DXE | ||
| Z-2889-2011 | D-10 Dual Program Reorder Pack; contains 400 HbA1c or 200 HbA2/F/A1c tests. Kits include... | Bio-Rad Laboratories Inc. | LCP | ||
| Z-3031-2011 | ARCHITECT C-Peptide Reagent Kit; a chemiluminescent microparticle immunoassay (CMIA) for... | Abbott Medical | JKD | ||
| Z-0161-2013 | Class I | Medpro Elastomeric Infusion Pump. AccuFlux, Model # CT-0020-100H. Product Usage: The... | First Medical Source LLC | MEB | |
| Z-2165-2017 | Class II | Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set Model Number(s)... | Horiba Instruments Incorporated | CFJ | |
| Z-0447-2012 | Box labeled in part, "REF: 72-1000***IQ SYSTEM IQ INTELLIGENT DRIVER 16.51CM (6.5")(L)... | Biomet Microfixation | HBF | ||
| Z-0186-2012 | Breeze Self-Adhesive Resin Cement, Part Number: N97A, Product Usage: The intended use... | Sybron Dental Specialties, Inc. | EMA | ||
| Z-3129-2011 | VIDAS Chlamydia test kits VIDAS Chlamydia is an automated qualitative test for use on... | bioMerieux, Inc. | LJC | ||
| Z-3032-2011 | Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia... | GE Healthcare | MHX | ||
| Z-0177-2012 | Capintec CRC 25 PET, item number 5130-3217 with Software Revisions 2.01 and 2.02 PET... | Mirion Technologies (Capintec), Inc. | KPT | ||
| Z-3111-2011 | Philips Medical: 865047 IntelliVue Clinical Information Portfolio Release D.03 865209... | Philips North America LLC | DXJ | ||
| Z-2976-2011 | Allura Xper Systems Models: Allura Xper FD10 (F/C)-Biplane Fixed Allura Xper FD10/10... | Philips North America LLC | IZI | ||
| Z-0123-2012 | Wilderness First Aid Kit, Part Number 4120; UPC 0-91966-04120-6, contains 110 Pieces... | Lifeline First Aid LLC | LRR | ||
| Z-0122-2012 | Mountain First Aid Kit, Part Number 4118; UPC 0-91966-04118-3, contains 88 Pieces. The... | Lifeline First Aid LLC | LRR | ||
| Z-0121-2012 | Highlands First Aid Kit, Part Number 4116, UPC 0-91966-04116-9, contains 65 Pieces. The... | Lifeline First Aid LLC | LRR | ||
| Z-0120-2012 | ARC DISASTER KIT (American Red Cross), Part Number 7201, UPC 0-91966-04708-6, The kit is... | Lifeline First Aid LLC | LRR | ||
| Z-0119-2012 | Base Camp First Aid Kit, Part Number 4150, UPC 0-91966-04150-3, contains 171 pieces. The... | Lifeline First Aid LLC | LRR | ||
| Z-3076-2011 | Hamamatsu model L10951-35 Micro Focus x-ray generator. The x-ray generator is... | Hamamatsu Corp. | RBS | ||
| Z-3163-2011 | TomoMobile, Hi-Art System, H-0000-0003, TomoTherapy 1240 Deming Way, Madison, WI... | Accuray Incorporated | MUJ | ||
| Z-3022-2011 | Eclipse Treatment Planning System, 4D Structure Merge Tool Option in Eclipse Release 8.5... | Varian Medical Systems, Inc. | MUJ | ||
| Z-3178-2011 | STOCKERT 70 Radio Frequency Generator, Catalog Number 57001 Indicated for use with a... | Biosense Webster Inc | LPB | ||
| Z-3050-2011 | Smith & Nephew, Tendon Stripper, Slotted, 5.0 mm I.D. x 12 working length... | Smith & Nephew, Inc. | LXH | ||
| Z-2855-2011 | MatriStem Plastic Surgery Matrix XS Intended for implantation to reinforce tissue where... | ACell, Inc | FTM | ||
| Z-0967-2013 | Class II | ILLICO Straight CP TI Rod, -5.5MM x 110M; REF#73601-110; Qty 1; LBL-005; REV.B; RX ONLY... | Alphatec Spine, Inc. | KWP | |
| Z-1490-2012 | Class I | Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library, Part Number... | Baxter Healthcare Corporation | FRN | |
| Z-3081-2011 | Mini MaxLock Extreme Plating System Case & Tray, Model Number(s): MXM-901, Product... | TORNIER Inc. | HRS | ||
| Z-2916-2011 | Vital Sign elance Monitor, Model 93300 Spacelabs Healthcare, Llc. A vital signs patient... | GE Healthcare | MHX | ||
| Z-3054-2011 | @ Home Strep Test Rapid Strep Test Product Usage: For in-vitro diagnostic use... | Jay Bird Investments Inc | GTY | ||
| Z-2837-2011 | Baxter Interlink System Non-DEHP I.V. Catheter Extension Set, 6.6(17 cm), Volume 0.8 mL... | Baxter Healthcare Corporation | FPA | ||
| Z-2985-2011 | ATLANTIS(R) Anterior Cervical Plate System Screw Caddy; Self Drilling Fixed Screw Caddy... | Medtronic Sofamor Danek USA Inc | XLH | ||
| Z-2984-2011 | ATLANTIS(R) Anterior Cervical Plate System Screw Caddy; Self Tapping Variable Screw... | Medtronic Sofamor Danek USA Inc | XLH | ||
| Z-2945-2011 | Vanguard PS Open Box Femoral 70 MM Left Interlock, " FOR CEMENTED USE ONLY" CO-CR-MO... | Zimmer GmbH | JWH | ||
| Z-3075-2011 | GE Healthcare, DASH 3000, 4000, 5000 Patient Monitors The Dash 3000/4000/5000 patient... | GE Healthcare | MHX | ||
| Z-0924-2013 | Class II | Genesis Straight Esthetic 5.0 mm 3. mm Cuff Abutment Part Number: G71205 Genesis implant... | Keystone Dental Inc. | NHA | |
| Z-0923-2013 | Class II | Genesis Straight Esthetic 4.0 mm 1mm Cuff Abutment Part Number: G71200 Genesis implant... | Keystone Dental Inc. | NHA | |
| Z-3043-2011 | Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40... | Medtronic Neuromodulation | LKK | ||
| Z-2930-2011 | Intuitive Surgical da Vinci Si Surgical System (IS3000); Mfg by: Intuitive Surgical... | Intuitive Surgical, Inc. | NAY | ||
| Z-3161-2011 | TiLite ZR and ZRA Series 2 are mechanical wheelchairs. Devices are sold under brand name... | TiSport, LLC | IOR | ||
| Z-2853-2011 | Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Baxter... | Baxter Healthcare Corporation | FRN | ||
| Z-2469-2012 | Class II | Catheter Irrigation Set labeled in part: ***24K Arthroscopy Outflow/Suction Tubing... | Linvatec Corporation | GBX | |
| Z-0521-2012 | Triage Drugs of Abuse Panel Plus TCA 25 Test Kit, PN (Model Number) 92000 An immunoassay... | Alere San Diego, Inc. | DKZ | ||
| Z-2989-2011 | INTRABEAM Shielding Material Flat 20 x 20 cm, Sterile/FO 0.05 mm Pb Equivalent... | Carl Zeiss Meditec Inc | JAD |