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Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Device Recalls

2,093 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,093 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 2,093 FDA device recalls in NJ.

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DateProductReasonClassFirm
Sep 20, 2018 Cardiosave Hybrid IABP, Part Number 0998-00-0800-53 There is a potential for interruption and/or inability to start therapy to the patient prior to o... Class I Maquet Datascope Corp - Cardiac Assist Division
Sep 13, 2018 Abbott i-STAT CG8+ Cartridges intended for use in the in vitro quantification... Inaccurate potassium results may be generated. When testing with control fluid and/or patient sam... Class II Abbott Point Of Care Inc.
Sep 12, 2018 Tritanium TL Steerable Inserter, Cat. No. 48930000, UDI 07613327381900 Pro... The firm received complaints related to the locking mechanism on the steerable inserter not funct... Class II Howmedica Osteonics Corp.
Sep 10, 2018 Sterile Knee Instruments Disposable Fluted Headless Pins, DIA 3.2mm LNTH 89mm... Potential for outer pouch sterile barrier to be compromised Class II Howmedica Osteonics Corp.
Aug 30, 2018 BD Vacutainer Specimen Collection Cups, Cat. No. 364975 BD Vacutainer Urine Collection Cups may contribute to a slight elevation of Red Blood Cell (RBC) ... Class II Becton Dickinson & Company
Aug 30, 2018 KIT URIN CUP PLC 16X100 10.0 UA YEL, Cat. No. 364981: Urine Collection Kit fo... BD Vacutainer Urine Collection Cups may contribute to a slight elevation of Red Blood Cell (RBC) ... Class II Becton Dickinson & Company
Aug 30, 2018 Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00 The firm has identified performance anomalies with the device caused when more than 64 TD60 telem... Class II Mindray DS USA, Inc. dba Mindray North America
Aug 30, 2018 KIT URIN CUP 16X100 8.0 CONI UA YEL, Cat. No. 364989 BD Vacutainer Urine Cup... BD Vacutainer Urine Collection Cups may contribute to a slight elevation of Red Blood Cell (RBC) ... Class II Becton Dickinson & Company
Aug 30, 2018 BD Vacutainer Urine Collection Cups, Cat. No. 364941 BD Vacutainer Urine Collection Cups may contribute to a slight elevation of Red Blood Cell (RBC) ... Class II Becton Dickinson & Company
Aug 23, 2018 BD NEXIVA Closed IV Catheter System Dual Port 18GA 1.25 IN (BD Nexiva Cathete... One lot of the specified needles is not performing as intended due to a failure in the needle tip... Class II Becton Dickinson & Company
Aug 16, 2018 BioMend Extend, REF# 0142Z, Synthetic bone grafting material. There is a possibility that the product was packaged in the wrong box. Specifically, the product... Class III Collagen Matrix, Inc.
Aug 13, 2018 AVS Aria Cage, Catalog Number 48753212 Product Usage: The Stryker Spine A... The anterior and posterior markers on the cage were on the incorrect/opposite sides of the cage. Class II Stryker Spine
Aug 6, 2018 Polyisoprene condomns Product Usage: The Durex Synthetic polyisoprene mal... Product marketed in U.S. does not have sufficient data to ensure that it will meet the internal b... Class II Reckitt Benckiser LLC
Jul 24, 2018 Diagnostica Stago STA N¿oplastine¿ CI Plus, 10 ml vial. In-Vitro Diagnostic... QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %) Class II Diagnostica Stago, Inc.
Jul 24, 2018 Diagnostica Stago STA N¿oplastine¿ CI, 10 ml vial. In-Vitro Diagnostic for d... QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %) Class II Diagnostica Stago, Inc.
Jul 23, 2018 Durex Real Feel Polyisoprene Condoms, 10 count and 24 count, SKU Numbers 0234... The products failed the filed specification of 1.0kPa for Burst Pressure. Class II Reckitt Benckiser LLC
Jul 12, 2018 VITROS Immunodiagnostic Products - TSH Reagent Pack (10758750000227) 1912997 The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic ... Class II Ortho Clinical Diagnostics Inc
Jul 12, 2018 VITROS Immunodiagnostic Products - Prolactin Reagent Pack (10758750000111) 1... The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic ... Class II Ortho Clinical Diagnostics Inc
Jul 12, 2018 VITROS Immunodiagnostic Products - FSH Reagent Pack (10758750000302) 1931922 The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic ... Class II Ortho Clinical Diagnostics Inc
Jul 12, 2018 VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266 The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic ... Class II Ortho Clinical Diagnostics Inc
Jun 29, 2018 MAYFIELD Infinity XR2 Base Unit-Extended, Part Number A2079E The MAYFIELD... There is a potential for the knob assembly in the swivel adapter to fracture/break during use. Class II Integra LifeSciences Corp.
Jun 29, 2018 MAYFIELD INFINITY XR2 LOW PROFILE BASE UNIT, Part Number A2079A The MAYFI... There is a potential for the knob assembly in the swivel adapter to fracture/break during use. Class II Integra LifeSciences Corp.
Jun 29, 2018 MAYFIELD INFINITY XR2 BASE UNIT, Part Number A2079 The MAYFIELD¿ Infinity... There is a potential for the knob assembly in the swivel adapter to fracture/break during use. Class II Integra LifeSciences Corp.
Jun 29, 2018 MAYFIELD SPINE TABLE ADAPTOR RADIOLUCENT, Part Number A2600R The MAYFIELD... There is a potential for the knob assembly in the swivel adapter to fracture/break during use. Class II Integra LifeSciences Corp.
Jun 8, 2018 PDS Plus Antibacterial (Polydioxanone) Suture-PDS PLUS Undyed Suture 45cm (18... Products do not meet a tensile strength specification Class II Ethicon, Inc.
Jun 8, 2018 PDS II (Polydioxanoe) Suture Dyed & Undyed-PDSII Undyed 45cm (18") 5-0 Single... Products do not meet a tensile strength specification Class II Ethicon, Inc.
Jun 8, 2018 PDS Plus Antibacterial Suture-PDS PLUS Undyed Suture 45cm (18") 5-0 Single Ar... Products do not meet a tensile strength specification Class II Ethicon, Inc.
May 22, 2018 LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-136 The recalling firm has received a higher than expected number of complaints documenting femoral h... Class II Howmedica Osteonics Corp.
May 22, 2018 LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-236 The recalling firm has received a higher than expected number of complaints documenting femoral h... Class II Howmedica Osteonics Corp.
May 22, 2018 LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-140 The recalling firm has received a higher than expected number of complaints documenting femoral h... Class II Howmedica Osteonics Corp.
May 22, 2018 LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-144 The recalling firm has received a higher than expected number of complaints documenting femoral h... Class II Howmedica Osteonics Corp.
May 22, 2018 LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-336 The recalling firm has received a higher than expected number of complaints documenting femoral h... Class II Howmedica Osteonics Corp.
May 22, 2018 LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-044 The recalling firm has received a higher than expected number of complaints documenting femoral h... Class II Howmedica Osteonics Corp.
May 22, 2018 LFIT Anatomic CoCr Femoral Heads, 6260-9-036 The recalling firm has received a higher than expected number of complaints documenting femoral h... Class II Howmedica Osteonics Corp.
May 22, 2018 LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-040 The recalling firm has received a higher than expected number of complaints documenting femoral h... Class II Howmedica Osteonics Corp.
May 9, 2018 ImagePilot, Model No. D9MA Panasonic has issued a Mandatory Product Safety Notice, indicating a possibility of battery ignit... Class II Konica Minolta Medical Imaging USA, Inc.
May 9, 2018 CS-7, Model No. A4C1 Panasonic has issued a Mandatory Product Safety Notice, indicating a possibility of battery ignit... Class II Konica Minolta Medical Imaging USA, Inc.
May 7, 2018 PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746 The needle associated with certain suture product codes has the potential to perforate the packag... Class II Ethicon, Inc.
May 7, 2018 PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879 The needle associated with certain suture product codes has the potential to perforate the packag... Class II Ethicon, Inc.
May 7, 2018 PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647 The needle associated with certain suture product codes has the potential to perforate the packag... Class II Ethicon, Inc.
May 7, 2018 PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981 The needle associated with certain suture product codes has the potential to perforate the packag... Class II Ethicon, Inc.
May 7, 2018 PRONOVA SUTURE BLUE 122CM M1.5, D10189 The needle associated with certain suture product codes has the potential to perforate the packag... Class II Ethicon, Inc.
May 7, 2018 PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748 The needle associated with certain suture product codes has the potential to perforate the packag... Class II Ethicon, Inc.
May 7, 2018 PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662 The needle associated with certain suture product codes has the potential to perforate the packag... Class II Ethicon, Inc.
May 7, 2018 PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688 The needle associated with certain suture product codes has the potential to perforate the packag... Class II Ethicon, Inc.
May 7, 2018 PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844 The needle associated with certain suture product codes has the potential to perforate the packag... Class II Ethicon, Inc.
May 7, 2018 PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416 The needle associated with certain suture product codes has the potential to perforate the packag... Class II Ethicon, Inc.
May 7, 2018 PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988 The needle associated with certain suture product codes has the potential to perforate the packag... Class II Ethicon, Inc.
May 7, 2018 PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768 The needle associated with certain suture product codes has the potential to perforate the packag... Class II Ethicon, Inc.
May 7, 2018 PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995 The needle associated with certain suture product codes has the potential to perforate the packag... Class II Ethicon, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types, from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.