510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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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

59,544 records, page 626 of 1191
FDA device recalls, page 626 of 1191
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0144-2016Class IIConFormis iTotal CR Knee Replacement System- ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED...ConforMIS, Inc.JWH
Z-0143-2016Class IIConForMIS iDuo Knee Bicompartmental Knee Replacement System , iDUO G2, Right Medial...ConforMIS, Inc.NPJ
Z-0142-2016Class IIConForMIS iDuo Bicompartmental Knee Replacement System iDUO G2, Left Lateral Catalog...ConforMIS, Inc.NPJ
Z-2811-2015Class IISynthes Cranial Flap Tube Clamp and Crimping Device Product Usage: The Synthes Cranial...Synthes (USA) Products LLCGXN
Z-0141-2016Class IIConForMIS iUni Unicondylar Knee Replacement System- iUNI G2, Right Medial Catalog...ConforMIS, Inc.JWH
Z-0140-2016Class IIConForMIS iUNI Unicondylar Knee Replacement System iUNI G2, Right Lateral Catalog...ConforMIS, Inc.OOG
Z-0139-2016Class IIConForMIS Unicondylar Knee Replacement System iUNI G2, Left Medial Catalog Number...ConforMIS, Inc.OOG
Z-0138-2016Class IIConForMIS iUni Unicondylar Knee Replacement System: iUNI G2, Left Lateral Catalog...ConforMIS, Inc.OOG
Z-0241-2016Class IIDeRoyal Sterile Custom Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical...DeRoyal Industries, Inc.LRO
Z-0240-2016Class IIDeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution...DeRoyal Industries, Inc.LRO
Z-0228-2016Class IIMATResponder Tourniquet; Catalog number MATR: UPC 78353 00008; MATCombat Tourniquet...Pyng Medical Corp.GAX
Z-0110-2016Class IIAccess Free T3 Reagent Kit, P/N A13422 The Access Free T3 assay is a paramagnetic...Siemens Healthcare Diagnostics Inc.CDP
Z-0183-2016Class IIADVIA Chemistry XPT Chemistry Systems, Siemens Material Number (SMN) 10723034. An...Siemens Healthcare Diagnostics Inc.JGS
Z-1394-2017Class IIBD AffirM VPIII Microbial Identification TestBecton Dickinson & CoMLA
Z-0150-2016Class IIPerifix Continous Epidural Anesthesia Pain Control Trays; Injection of anesthetics to...B Braun Medical IncCAZ
Z-0115-2016Class IIMRIdian ViewRay Radiation Therapy System, ViewRay Is indicated for stereotactic...Viewray Systems, Inc.IYE
Z-2820-2015Class IIZimmer Guide Wires for orthopedic procedures.Zimmer GmbHFZX
Z-0122-2016Class IIIAlere Cholestech LDX Multianalyte Controls, PN 88769 and 88773. Enables users to...Alere San Diego, Inc.JJY
Z-2825-2015Class IIArrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush SyringesArrow International LLC (subsidiary of Teleflex Incorporated)FOZ
Z-2797-2015Class IIContra-Angles CA1:1L EVO 15 Catalog numbers: 1600939-001 and 1600938-001 Used for...Bien-Air Dental SAEGS
Z-2817-2015Class IIICD4 (SK3), FITC; Contains CD4 FITC with gelatin and 0.1% sodium Azide. Catalog number...Becton, Dickinson and Company, BD BiosciencesGKZ
Z-1195-2019Class IIsyngo Lab Data Manager System - Product Usage: syngo Lab Data Manager is a clinical...Siemens Healthcare Diagnostics Inc.JQP
Z-2780-2015Class IIThruPort Knot Pusher. This device is sold individually (Model KP1) and as part of the...Edwards Lifesciences LLCDPT
Z-1096-2016Class IINuOSS Cancellous Intended for use in dental surgery.Collagen Matrix, IncNPM
Z-0133-2016Class IIAmbitex NMD400 Nitrile Exam Gloves size medium. General Hospital and Personal...Medtronic, Inc.LZA
Z-0191-2016Class IIRegard, Item Number 800500002, Sterile, CV0578B - CV PACK- Custom surgical kit for...Resource Optimization & Innovation, LLCLHC
Z-0190-2016Class IIRegard, Item Number 800301001, Sterile, CV0708A - OPEN HEART- Custom surgical kit for...Resource Optimization & Innovation, LLCLHC
Z-0189-2016Class IIRegard, Item Number 830500003, Sterile, CV0578C - CV PACK - Custom surgical kit for...Resource Optimization & Innovation, LLCLHC
Z-0188-2016Class IIRegard, Item Number 830565001, CV0654A - PEDIATRIC HEART - Custom surgical kit for...Resource Optimization & Innovation, LLCLHC
Z-0187-2016Class IIRegard, Item Number 830054001, CV00625A - OPEN HEART A&B - Custom surgical kit for...Resource Optimization & Innovation, LLCLHC
Z-0186-2016Class IIRegard, Item Number 830054002, CV00625B - OPEN HEART A&B - Custom surgical kit for...Resource Optimization & Innovation, LLCLHC
Z-0185-2016Class IIRegard, Item Number 830045, CV0443D - CV BUNDLE - Custom surgical kit for cardiovascular...Resource Optimization & Innovation, LLCLHC
Z-2766-2015Class IIBoston Scientific, WATCHMAN Access System Access Sheath with Dilator, 14F Single curve(...Boston Scientific CorporationNGV
Z-0184-2016Class IIRegard, Item Number 830019, CV0214H -Custom surgical kit for cardiovascular surgery.Resource Optimization & Innovation, LLCLHC
Z-0229-2016Class IIRegard Custom Surgical Pack, Item Number 880239, Sterile IV Pack. Custom procedure trays...Resource Optimization & Innovation, LLCLRO
Z-2765-2015Class IIBoston Scientific, WATCHMAN Left Atrial Appendage Closure Device with Delivery System...Boston Scientific CorporationNGV
Z-2816-2015Class IISiemens RAPIDPoint 500 Measurement Cartridge Lactate (100) tests Part Number...Siemens Healthcare Diagnostics Inc.KHP
Z-2815-2015Class IISiemens RAPIDPoint 500 Measurement Cartridge Lactate (250) tests Part Number...Siemens Healthcare Diagnostics Inc.KHP
Z-2814-2015Class IISiemens RAPIDPoint 500 Measurement Cartridge Lactate (400) tests Part Number...Siemens Healthcare Diagnostics Inc.KHP
Z-2813-2015Class IISiemens RAPIDPoint 500 Measurement Cartridge Lactate (750 tests) Part Number...Siemens Healthcare Diagnostics Inc.KHP
Z-0246-2016Class IIRusch Flexi-slip tracheal tube Stylet, Size Ch 6, Sterile, Teleflex Medical.Teleflex MedicalBSR
Z-0245-2016Class IIRsch Flexi-Slip Endotracheal Tube Stylet with Soft Distal Tip, Sterile, Rx only, Teleflex...Teleflex MedicalBSR
Z-2819-2015Class IIZimmer, Reprocessed Zimmer Tourniquet Cuffs,34" Single Hose Single Bladder Brown (PLC)...Sterilmed IncKCY
Z-2792-2015Class IITerumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N...Terumo Cardiovascular Systems CorporationN/A
Z-2791-2015Class IITerumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N...Terumo Cardiovascular Systems CorporationN/A
Z-2790-2015Class IITerumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack P/N: 74077-01 Terumo...Terumo Cardiovascular Systems CorporationN/A
Z-2789-2015Class IITerumo Custom Cardiovascular Procedure Kit X-Coated Pediatric Pack P/N: 74039-02 Terumo...Terumo Cardiovascular Systems CorporationN/A
Z-2788-2015Class IITerumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack with FX25RE P/N...Terumo Cardiovascular Systems CorporationN/A
Z-2787-2015Class IITerumo Custom Cardiovascular Procedure Kit X-Coated Adult Pak P/N: 73124 Terumo...Terumo Cardiovascular Systems CorporationN/A
Z-2732-2015Class IIMagic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude tip...C.R. Bard IncKOD