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Vehicle Safety

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

2,057 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,057 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 2,057 FDA device recalls in NJ.

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DateProductReasonClassFirm
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 16, 2019 i-STAT cTnI cartridge i-STAT¿ cTnI blue cartridges may generate a higher than expected number of quality check codes. T... Class II Abbott Point Of Care Inc.
Oct 14, 2019 7% BSA (Bovine Serum Albumin), Product Code: 8262487 - Product Usage: is used... Potential for the instability of the diluents VITROS 7% BSA (Product Code 8262487) and VITROS Uri... Class II Ortho Clinical Diagnostics Inc
Oct 14, 2019 Urine Electrolyte Diluent, Product Code: 1112352 - Product Usage: used to dil... Potential for the instability of the diluents VITROS 7% BSA (Product Code 8262487) and VITROS Uri... Class II Ortho Clinical Diagnostics Inc
Oct 14, 2019 BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306547 Limited number of syringes labeled Posiflush Experimental Product and Not for Human Use being... Class II Becton Dickinson & Company
Oct 14, 2019 BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306575 (Canad... Limited number of syringes labeled Posiflush Experimental Product and Not for Human Use being... Class II Becton Dickinson & Company
Oct 3, 2019 Stryker X-Change Medial Wall Mesh Small (6-Petal)-Intended to be implanted to... Boxes of the 6-Petal X-Change Wall Mesh Small (Part # 0942-8-025) contain the 4-Petal X-Change Wa... Class II Howmedica Osteonics Corp.
Oct 3, 2019 Low Level Output Cable Interface to Philips Monitor For Use With Cardiosave... One lot of "Low Level Output Cable - Interface to Philips Monitor" was received from the supplier... Class II Datascope Corp.
Oct 1, 2019 Accutorr 7 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679... NIBP valve assembly board subject to this recall includes enhancements that are not included in t... Class II Mindray DS USA, Inc. dba Mindray North America
Oct 1, 2019 Rosie4 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00,... NIBP valve assembly board subject to this recall includes enhancements that are not included in t... Class II Mindray DS USA, Inc. dba Mindray North America
Oct 1, 2019 Rosebud Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00... NIBP valve assembly board subject to this recall includes enhancements that are not included in t... Class II Mindray DS USA, Inc. dba Mindray North America
Oct 1, 2019 Accutorr 3 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679... NIBP valve assembly board subject to this recall includes enhancements that are not included in t... Class II Mindray DS USA, Inc. dba Mindray North America
Sep 16, 2019 13 Fr. Trialysis Catheter with Alphacurve. Catalog No. 5653150. UDI: 00801741... A portion of the lot was incorrectly packaged with a 12.5cm catheter instead of a 15cm catheter. Class II Becton Dickinson & Company
Sep 12, 2019 Cerelink ICP Monitor, Model Number 826820; intended for use as an interface ... There is a potential for a progressive decline in observed ICP readings of the monitor during use. Class II Integra LifeSciences Corp.
Sep 10, 2019 A&E Medical Thorecon Plating System Kits Model No. 94-1300-04-S. For fractur... Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding d... Class II Alto Development Corp
Sep 10, 2019 A&E Medical Thorecon Plating System Kits Model No. 94-1500-04-S. For fractur... Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding d... Class II Alto Development Corp
Sep 10, 2019 A&E Medical Thorecon Plating System Kits Model No. 94-1200-08. For fracture ... Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding d... Class II Alto Development Corp
Sep 10, 2019 A&E Medical Thorecon Plating System Kits Model No. 94-1700-10. For fracture ... Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding d... Class II Alto Development Corp
Sep 10, 2019 A&E Medical Thorecon Plating System Kits Model No. 94-1400-04. For fracture ... Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding d... Class II Alto Development Corp
Aug 28, 2019 1 STRATAFIX" Spiral PDS Plus Violet 12" (30 cm) CT-1 Needle, SXPP1B429 The product do not meet certain internal testing specifications. Class II Ethicon, Inc.
Aug 28, 2019 1 STRATAFIX" Spiral PDS Plus Violet 36" (90cm) CTX Needle, SXPP1B402 The product do not meet certain internal testing specifications. Class II Ethicon, Inc.
Aug 28, 2019 1 STRATAFIX Spiral PDS Plus Violet 18" (45cm) OS-6 Needle, SXPP1B201 The product do not meet certain internal testing specifications. Class II Ethicon, Inc.
Aug 22, 2019 The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is a woven double ... Based on an internal incident report, Getinge/Intervascular SAS has identified that the one (1) H... Class II GETINGE US SALES LLC
Aug 19, 2019 TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 RIGHT Catalog # 5541-A-202 - ... Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral com... Class II Howmedica Osteonics Corp.
Aug 19, 2019 TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 LEFT Catalog # 5541-A-201 - P... Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral com... Class II Howmedica Osteonics Corp.
Aug 19, 2019 TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 LEFTTriathlon Femoral Distal A... Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral com... Class II Howmedica Osteonics Corp.
Aug 19, 2019 TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 RIGHT Catalog # 5542-A-202 - ... Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral com... Class II Howmedica Osteonics Corp.
Aug 15, 2019 QuickGraft¿ Model # 430PST Measurement listed on the label is not taken under tension, and this would cause possible extensi... Class II Musculoskeletal Transplant Foundation, Inc.
Aug 13, 2019 STRATAFIX Spiral PDS Plus Violet 18 (45cm) CT-1 Needle Product code: SXPP1B... The product does not meet certain internal strength testing specifications. Class II Ethicon, Inc.
Aug 13, 2019 STRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle Product code: SXPP1B4... The product does not meet certain internal strength testing specifications. Class II Ethicon, Inc.
Aug 12, 2019 ZEUS ELISA Parvovirus B19 IgM Test System, UDI 00845533001755 - Product Usage... FDA inspection identified that due to increased positivity (false positives) on the Parvovirus B1... Class II Zeus Scientific, Inc.
Aug 7, 2019 Integra Jarit GEMINI CLAMP 9 1/4 inch - used in vascular and cardiothoracic p... A small crack at the box lock corner may after multiple cleaning and sterilization cycles produce... Class II Integra LifeSciences Corp.
Aug 1, 2019 8 G x 10 CM Jamshidi Crown Bone Marrow biopsy/Aspiration Needle with MAC Cat... Product Pouches may not be sealed properly and compromise the sterility of the device Class II Becton Dickinson & Company
Jul 31, 2019 BD Vacutainer¿ Push Button Blood Collection Set with Pre-Attached Holder Ca... Separation of front and rear barrels upon activation of the safety feature that retracts the needle Class II Becton Dickinson & Company
Jul 22, 2019 Dynex DSX Software-IVD ELISA Assays effected as follows: DSX Assay File Sof... Assay files used on the open Dynex DSX Instrument to process IVD ELISA samples-programming error ... Class II Zeus Scientific, Inc.
Jul 22, 2019 Getinge MCC Flow i Disposable CO2 absorber, used in anesthesia systems. Reversed expiration and manufacturing date on the label Class II GETINGE US SALES LLC
Jul 19, 2019 Codman ISOCOOL Bipolar Forceps-are indicated for cauterizing, coagulating, gr... Tips have an inadequate product insulation coating, which could result in the tips not coagulatin... Class II Integra LifeSciences Corp.
Jul 11, 2019 Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. Model Number BEQ-H... The sets are configured with quick connectors that have been assembled in reverse on the arterial... Class II Maquet Cardiovascular Us Sales, Llc
Jun 21, 2019 A&E Medical Corp. Ultra-Flex MYO/Wire Ultra-Flex Monopolar Pacing Wire Looped... Updated instructions for use: Ultra-Flex MYO/WIRE Monopolar pacing wire looped electrode (M-21 Se... Class II Alto Development Corp
Jun 19, 2019 Alpha Conducting solution product codes:3310-15 ACS - Product Usage: Electrod... Potential for failed stability antimicrobial effectiveness testing. Class II Pharmaceutical Innovations, Inc.
Jun 19, 2019 ElectroMist product codes: 36-3310-04 - Product Usage: Electrode Conductivity... Potential for failed stability antimicrobial effectiveness testing. Class II Pharmaceutical Innovations, Inc.
Jun 19, 2019 ElectroMist product codes: 36-3310-60 - Product Usage: Electrode Conductivity... Potential for failed stability antimicrobial effectiveness testing. Class II Pharmaceutical Innovations, Inc.
Jun 19, 2019 Alpha Conducting solution product codes: 3310-25 ASCR - Product Usage: Electr... Potential for failed stability antimicrobial effectiveness testing. Class II Pharmaceutical Innovations, Inc.
Jun 19, 2019 ElectroMist product codes: 36-3310-25 - Product Usage: Electrode conductivity... Potential for failed stability antimicrobial effectiveness testing. Class II Pharmaceutical Innovations, Inc.
Jun 18, 2019 Serrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590 Serrato 9.5mm... Discrepant length; Lot B88751 90mm screws were manufactured with a 100mm length instead of the re... Class II Howmedica Osteonics Corp.
Jun 17, 2019 Cardiosave Rescue IABP, 0998-00-0800-83 Intra-Aortic Balloon Pump For card... If battery maintenance is not performed appropriately, the battery may provide less than the mini... Class I Datascope Corp.

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.