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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
Aug 23, 2016 Integra Lumbar Drainage Set, REF 910120A, Sterile EO, Rx only, primary packag... During final sampling inspection, one of the lots was discovered with a total incomplete packagin... Class II Integra LifeSciences Corp.
Aug 23, 2016 CUSA Dissectron Fingertip Laparoscopic Cannula, REF F75221, Sterile EO, Rx on... During final sampling inspection, one of the lots was discovered with a total incomplete packagin... Class II Integra LifeSciences Corp.
Aug 23, 2016 Integra Straight Ventricular Catheter F8, 25 cm, Sterile EO, Rx only, package... During final sampling inspection, one of the lots was discovered with a total incomplete packagin... Class II Integra LifeSciences Corp.
Aug 23, 2016 Integra Drainage Accessory Kits, REF 910122, Sterile EO, Rx only, packaged in... During final sampling inspection, one of the lots was discovered with a total incomplete packagin... Class II Integra LifeSciences Corp.
Aug 23, 2016 Integra Ventricular Catheter Accessory Kit, REF 951303, Sterile EO, Rx only, ... During final sampling inspection, one of the lots was discovered with a total incomplete packagin... Class II Integra LifeSciences Corp.
Aug 23, 2016 Integral Lumbar Drainage Set, REF 910420, Sterile EO, Rx only, primary packag... During final sampling inspection, one of the lots was discovered with a total incomplete packagin... Class II Integra LifeSciences Corp.
Aug 18, 2016 Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor, REF 2101-0... Stryker Orthopaedics has received reports of the thread length protruding past the dome of the ac... Class II Stryker Howmedica Osteonics Corp.
Aug 15, 2016 Pentax Video Colonoscope is intended to be used with a PENTAX video processor... Pentax is initiating the product correction of several model numbers of Pentax's Colonoscope that... Class II Pentax of America Inc
Aug 15, 2016 Pentax Video Gastroscope is intended to be used with a Pentax video processor... PENTAX Medical is initiating this field action to provide customers that have purchased the affec... Class II Pentax of America Inc
Aug 12, 2016 The Connecting Bracket (Fixture) Device (1002.65A0) is designed as a connecti... Post Market Surveillance cases reported to Maquet showing instances in which the welded joint bet... Class II Maquet Cardiovascular Us Sales, Llc
Aug 8, 2016 BD Vacutainer Push Button Blood Collection Set, Sterile, Rx only, 0.6 x 19 mm... Becton Dickinson is recalling various lot numbers of BD Vacutainer Push Button Blood Collection S... Class II Becton Dickinson & Company
Aug 8, 2016 BD 23 G x .75 in. BD Vacutainer¿ Push Button Blood Collection Set with 12 in... BD has received multiple reports of units associated with the 23 G x .75 in. BD Vacutainer¿ Push... Class II Becton Dickinson & Company
Aug 4, 2016 MISAGO RX Self Expanding Peripheral Stem During recent routine testing, the MISAGO Peripheral Stent was found not to conform to product sp... Class II Terumo Medical Corp
Aug 2, 2016 catalog # 405612 BD Spinal Anesthesia Tray 22G x 3.5 in. BD" Quincke Spinal... A recall was initiated by Hospira, Inc. for several lots of 5% Lidocaine HCI and 7.5% Dextrose In... Class II Becton Dickinson & Company
Aug 1, 2016 Stryker Orthopaedics Patella Assembly Instrument, REF 3182-1000, Non-Sterile,... Upon failure of the press-fit, the clamping sub components and pins could disassociate from the S... Class II Stryker Howmedica Osteonics Corp.
Aug 1, 2016 ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Str... ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fib... Class II Ethicon, Inc.
Jul 26, 2016 AccuLIF PL 6-9mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLI... Since Stryker acquired the AccuLIF product in March of 2014, there have been Product Inquires (PI... Class II Howmedica Osteonics Corp.
Jul 26, 2016 AccuLIF PL 10-16mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The Accu... Since Stryker acquired the AccuLIF product in March of 2014, there have been Product Inquires (PI... Class II Howmedica Osteonics Corp.
Jul 26, 2016 AccuLIF PL 8-12mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuL... Since Stryker acquired the AccuLIF product in March of 2014, there have been Product Inquires (PI... Class II Howmedica Osteonics Corp.
Jul 21, 2016 FPS 35mm x 3.5 mm non-locking screw Mislabeling of a single batch of FPS 3.5 x 35 mm Locking Screw as being Non-Locking Screws. Class II Ortho Solutions Inc
Jul 21, 2016 Large QWIX Compression screw, dia. 7.5 mm L 90 mm, Lot No. FH86, Rx only, ... Labeling on the Qwix Screw product states that it is a "compression screw" instead of a "position... Class II Integra LifeSciences Corp.
Jul 20, 2016 Integra External Fixation System Slotted Post - Small Catalogue #12224228; In... Through the investigation of reported complaints Integra verified that there have been instances ... Class II Integra LifeSciences Corp.
Jul 20, 2016 Integra External Fixation System Universal Wire Fixation Bolt - 17.5 mm Catal... Through the investigation of reported complaints Integra verified that there have been instances ... Class II Integra LifeSciences Corp.
Jul 7, 2016 The TM Ardis Interbody System implant is a convex, straight TLIF or PLIF devi... This field action is being initiated following the firm's discovery of a procedural error in the ... Class III Zimmer Trabecular Metal Technology, Inc.
Jul 1, 2016 Orthopedic manual surgical instrument Usage: Exeter Rasp Handle is a reus... Malfunctioning of the Exeter Rasp/trial introducer/extractor Handle. Class II Stryker Howmedica Osteonics Corp.
Jul 1, 2016 Integra External Fixation System Rocker Bottom Model # 12225400. For use i... The silicone insert embedded in the rocker bottom has the potential to become dislodged or loose ... Class II Integra LifeSciences Corp.
Jun 30, 2016 Femoral Nail, A/R T2 Femur 011x280 mm T2 Femoral Nailing System is one of ... Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed t... Class II Stryker Howmedica Osteonics Corp.
Jun 30, 2016 Supracondylar Nail T2 SCN 09x300 mm T2 Supracondylar Nail System is intend... Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed t... Class II Stryker Howmedica Osteonics Corp.
Jun 29, 2016 TRYX Neuro Absorbable Antibacterial Envelope Product Usage: Indicated for... TRYX products are being recalled since the processes of spaying, welding, drying oven and polyme... Class II TYRX Inc.
Jun 29, 2016 TRYX Absorbable Antibacterial Envelope Product Usage: Indicated for stabi... TRYX products are being recalled since the processes of spaying, welding, drying oven and polyme... Class II TYRX Inc.
Jun 29, 2016 TRYX Antibacterial Envelope Rx Only Product Usage: Indicated for stabiliz... TRYX products are being recalled since the processes of spaying, welding, drying oven and polyme... Class II TYRX Inc.
Jun 23, 2016 Stryker Orthopaedics Modular Handle Triathlon Instruments, Non-Sterile, REF 6... Stryker Orthopaedic is voluntarily recalling the Triathlon Modular Handle because analysis reveal... Class II Stryker Howmedica Osteonics Corp.
Jun 23, 2016 Mindray DS USA Inc., Passport Series Patient Monitor intended for monitoring,... Mindray has identified a potential leakage issue with the CO2 Module's Dryline II Water Trap used... Class II Mindray DS USA, Inc. dba Mindray North America
Jun 23, 2016 Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Seconda... It was reported that the secondary locking mechanism, and its corresponding components, disassoci... Class II Stryker Howmedica Osteonics Corp.
Jun 17, 2016 Achillon Minimally Invasive Device for Achilles Tendon Rupture Treatment The... Data from internal studies suggests there may be a potential that the secondary package seal inte... Class II Integra LifeSciences Corp.
Jun 15, 2016 A7 Anesthesia Delivery System, a device used to administer to a patient, cont... Potential for a leak to occur on the back-up O2 and air e-size cylinder yokes on the A7 Anesthesi... Class II Mindray DS USA, Inc. dba Mindray North America
Jun 3, 2016 Stryker Orthopaedics Trident Constrained Liner Inserter/Impactor Tip, 22 mm, ... Impactors do not meet the required sterility assurance level (SAL) of 10-6 when using the recomme... Class II Stryker Howmedica Osteonics Corp.
May 31, 2016 Pentax Video Bronchoscope Designed to be used with a Pentax Video Processor... Pentax America Inc. is recalling various bronchoscopes which contain an incorrect Operation and R... Class II Pentax of America Inc
May 31, 2016 Ultrasound Video Bronchoscope The EB-1970UK, Ultrasound Video Bronchoscope,... The EB-1970UK Ultrasound Video Bronchoscope shipped between the clearance date of April 2014 and... Class II Pentax of America Inc
May 20, 2016 K-wire, Smooth Double-pointed 0.8 x 90mm, a component of the METASURG Capture... The affected K-wires do not meet specification requirements. Specifically, a) K-wires were made o... Class II Integra LifeSciences Corp.
May 17, 2016 cobas¿ Liat Influenza A/B Quality Control Kit; For use with cobas¿ Liat Inf... Kit labeled with the incorrect expiration date. Class III Roche Molecular Systems, Inc.
May 13, 2016 MEGA¿ 7.5Fr. 30cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK... It was discovered during post-quarantine packaging on 2/16/2016 that the IFU for the STATLOCK She... Class II Datascope Corporation
May 10, 2016 TS Series Depth Gauge for Integra Ti6 Internal Fixation System 2.0/2.5mm Scre... As a result of an internal investigation of a non-conformance it has been determined: 1) Depth Ga... Class II Integra LifeSciences Corp.
May 9, 2016 cobas¿ Liat¿ Analyzer Device was released with default pcal/gain settings for photometers instead of the pcal/gain set... Class II Roche Molecular Systems, Inc.
May 9, 2016 Small Patient ECC Pack, REF BEQ-TOP 24100, Product Usage: The HLM Tubing Set... Custom Tubing Set BEQ-TOP-24100 (Small Patient ECC Pack) was identified as possessing a level of ... Class II Datascope Corporation
Apr 29, 2016 Cadence Size 5 Left Tibial Tray Implant, designed to treat ankle arthritis th... As a result of an internal review of all labeling for the Cadence System, it was determined that ... Class II Integra LifeSciences Corp.
Apr 28, 2016 Excelsior Disposable Syringe Heparin Lock Flush, USP syringe (5 mL Fill in 10... Certain lots of Heparin Lock Flush, USP Syringes (5 ml Fill in 10 ml Syringe) failed Anti-Factor ... Class II Excelsior Medical Corp
Apr 25, 2016 Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-8... Some cartons used in the secondary packaging of Breathe Right Clear, Large, 30 ct. Nasal Strips w... Class III GSK Consumer Healthcare
Apr 21, 2016 Musculoskeletal Transplant Foundation, AFT Diverted Tube (3/4/Filled), indica... AFT Diverted Tubes are being recalled due to a customer complaint involving one unit which had an... Class II Musculoskeletal Transplant Foundation, Inc.
Apr 15, 2016 POROUS PATELLA 32MM X 10MM - 00587806532 POROUS PATELLA 35MM X 10MM- 0058... Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal i... Class II Zimmer Trabecular Metal Technology, 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.