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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
May 7, 2018 PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881 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) 8-0 BLUE, D8292 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, D9067 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 MONO POLY - SH-1 Taperpoint 1/2C, D10027 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 18" 7-0 D/A BV-1, DC631 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 Taper Point 3/8C, D10031 The needle associated with certain suture product codes has the potential to perforate the packag... Class II Ethicon, Inc.
May 3, 2018 CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), Part Number 0998-00-0800-... Ingress of fluids into the device can affect various electronic circuit boards which would preven... Class I Maquet Datascope Corp - Cardiac Assist Division
May 2, 2018 MagNA Pure 24 System, GMMI: 07290519001 Product Usage: The MagNA Pure 24... Cross-contamination of samples has been reported when running the existing protocol on the system... Class II Roche Molecular Systems, Inc.
Apr 11, 2018 The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated ... Approximately 3.4% of BD Vacutainer Plus Plastic Citrate Blood Collection Tubes (2.7mL) (light bl... Class II Becton Dickinson & Company
Apr 11, 2018 The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated ... Approximately 3.4% of BD Vacutainer Plus Plastic Citrate Blood Collection Tubes (2.7mL) (light bl... Class II Becton Dickinson & Company
Apr 11, 2018 The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated ... Approximately 3.4% of BD Vacutainer Plus Plastic Citrate Blood Collection Tubes (2.7mL) (light bl... Class II Becton Dickinson & Company
Apr 9, 2018 Angio-Seal Evolution Vascular Closure Device, Cat. No. C610135 Two lots of product were released for distribution prior to the completion of all required valida... Class II Terumo Medical Corp
Mar 22, 2018 BD Vacutainer¿ EDTA Lavender Top Tubes: Catalog Numbers: 1. 366401 (UDI: 5038... BD Vacutainer EDTA Lavender, Tan, and Pink Top Tubes and BD Vacutainer Lithium Heparin Green Top ... Class I Becton Dickinson & Company
Mar 22, 2018 BD Vacutainer¿ EDTA Tan Top Tube; Catalog Number: 367855 (UDI: 50382903678551) BD Vacutainer EDTA Lavender, Tan, and Pink Top Tubes and BD Vacutainer Lithium Heparin Green Top ... Class I Becton Dickinson & Company
Mar 22, 2018 BD Vacutainer¿ EDTA Pink Top Tube; Catalog Numbers: 1. 367842 (UDI: 503829036... BD Vacutainer EDTA Lavender, Tan, and Pink Top Tubes and BD Vacutainer Lithium Heparin Green Top ... Class I Becton Dickinson & Company
Mar 22, 2018 BD Vacutainer¿ Lithium Heparin Green Top Tube; Catalog Numbers: 1. 366664 (UD... BD Vacutainer EDTA Lavender, Tan, and Pink Top Tubes and BD Vacutainer Lithium Heparin Green Top ... Class I Becton Dickinson & Company
Mar 20, 2018 BD Vacutainer¿ Push Button Blood Collection Set 0.6 x 19 mm x 305 mm 23G x ¿... Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6. Class II Becton Dickinson & Company
Mar 20, 2018 BD Vacutainer¿ Push Button Blood Collection Set 0.8 x 19 mm x 305 mm 21G x ¿ ... Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6. Class II Becton Dickinson & Company
Mar 20, 2018 BD Vacutainer¿ Ultra TouchTM Push Button Blood Collection Set 0.6 x 19 mm x 3... Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6. Class II Becton Dickinson & Company
Mar 7, 2018 Evicel Accessory Device - 45 cm Flexible Tip (SET OF 3), Product Code EVT45. ... Products labeled for distribution outside the United States may have been distributed to customer... Class II Ethicon, Inc.
Mar 6, 2018 Manuka Honey Wound Gel Catalogue No: 716597 Product Usage: Helps maintai... Incorrect gel part number listed in a master manufacturing record Class II Integra LifeSciences Corp.
Feb 21, 2018 Intra-Aortic Balloon Catheter Mega 8FR 50cc Product Usage: The intra-aortic... The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Co... Class II Datascope Corporation
Feb 21, 2018 Intra-Aortic Balloon Catheter Mega 7.5FR 40cc Product Usage: The intra-ao... The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Co... Class II Datascope Corporation
Feb 21, 2018 Intra-Aortic Balloon Catheter Mega 7.5FR 30cc Product Usage: The intra-ao... The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Co... Class II Datascope Corporation
Feb 13, 2018 BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x75mm 3.5ml PLBL Gold, Ca... Tubes may exhibit stopper creepout/pullout, where the stopper dissociates from the tube Class II Becton Dickinson & Company
Feb 13, 2018 BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x100mm 5.0ml PLBL Gold, C... Tubes may exhibit stopper creepout/pullout, where the stopper dissociates from the tube Class II Becton Dickinson & Company
Feb 13, 2018 Pentax Video Duodenoscope Model: ED-3490TK (UDI of design being recalled: 049... The duodenoscopes are being recalled in order to replace the forceps elevator mechanism, the O-ri... Class II Pentax of America Inc
Feb 7, 2018 VOLISTA StandOP Surgical Light; Model numbers VLT600 SF AIM STP, VLT600 DF AI... The manufacturer received complaints indicating that the device's central handle holder detaches ... Class II GETINGE US SALES LLC
Jan 30, 2018 Triathlon Revision Knee Catalog #5545-A-301 and Catalog #5546-A-601 The kn... Customers may receive the incorrect size implant from what is labeled on the box. Class II Howmedica Osteonics Corp.
Jan 24, 2018 Hematology Diluent M-53D used with BC-5390 Hematology Analyzer; Part Number: ... Certain lots of M-30D diluent used with BC-3200 and BC-3600 Hematology Analyzers and M-53D diluen... Class II Mindray DS USA, Inc. dba Mindray North America
Jan 24, 2018 Hematology Diluent M-30D used with BC-3200 and BC-3600 Hematology Analyzer; P... Certain lots of M-30D diluent used with BC-3200 and BC-3600 Hematology Analyzers and M-53D diluen... Class II Mindray DS USA, Inc. dba Mindray North America
Jan 12, 2018 Knee Prosthesis, Sterile, Single-Use devices Product Usage: The knee syst... Firm became aware that the specific product/lot combinations referenced above may contain the inc... Class II Howmedica Osteonics Corp.
Jan 10, 2018 PDS Plus Antibacterial (Polydioxanone) Suture Size 1 PDS PLUS Violet 27 Si... Three (3) lots were distributed with the incorrect expiry date on the label. The lots were label... Class II Ethicon, Inc.
Jan 10, 2018 PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Si... Three (3) lots were distributed with the incorrect expiry date on the label. The lots were label... Class II Ethicon, Inc.
Jan 10, 2018 PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Si... Three (3) lots were distributed with the incorrect expiry date on the label. The lots were label... Class II Ethicon, Inc.
Jan 3, 2018 HEMASHIELD Knitted Double Velour Cardiovascular Fabric A probable mislabeling of the product: a different-sized product is referenced on the product pac... Class II GETINGE US SALES LLC
Dec 21, 2017 Custom Made Implant System with Minimum Invasive Grower (MIG) component From March 2007 to October 2014, product did not contain updated instructions for use (IFU) to cl... Class II Howmedica Osteonics Corp.
Dec 20, 2017 The humeral stems trials are packaged in a kit for Titan Modular Shoulder Sys... Incidents of stem trial breakage were reported to the firm suggesting that these fractures all oc... Class II Integra LifeSciences Corp.
Dec 18, 2017 Johnson & Johnson BAND-AID¿ Brand First Aid Products SECURE-FLEX¿ Wrap (size:... Johnson & Johnson Consumer Inc. is initiating a voluntary, Class II recall at the retail level in... Class II Johnson & Johnson Consumer, Inc.
Dec 18, 2017 COACH¿ Self-Adhering Sports Wrap (size: 3in) Johnson & Johnson Consumer Inc. is initiating a voluntary, Class II recall at the retail level in... Class II Johnson & Johnson Consumer, Inc.
Dec 18, 2017 Johnson & Johnson BAND-AID¿ Brand First Aid Products HURT-FREE¿ Wrap (size: 1in) Johnson & Johnson Consumer Inc. is initiating a voluntary, Class II recall at the retail level in... Class II Johnson & Johnson Consumer, Inc.
Dec 18, 2017 Johnson & Johnson BAND-AID¿ Brand First Aid Products HURT-FREE¿ Wrap (size: 2in) Johnson & Johnson Consumer Inc. is initiating a voluntary, Class II recall at the retail level in... Class II Johnson & Johnson Consumer, Inc.
Dec 18, 2017 Johnson & Johnson BAND-AID¿ Brand First Aid Products SECURE-FLEX¿ Wrap (size:... Johnson & Johnson Consumer Inc. is initiating a voluntary, Class II recall at the retail level in... Class II Johnson & Johnson Consumer, Inc.
Dec 18, 2017 COACH¿ Self-Adhering Sports Wrap (size: 2in) Johnson & Johnson Consumer Inc. is initiating a voluntary, Class II recall at the retail level in... Class II Johnson & Johnson Consumer, Inc.
Dec 4, 2017 Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A7AP, UDI: 0456014194... There is a risk of circuit board breakage within the main housing of the AC Adapter unit. Smoke m... Class II Konica Minolta Medical Imaging USA, Inc.
Dec 4, 2017 Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8WA, UDI: 0456014194... There is a risk of circuit board breakage within the main housing of the AC Adapter unit. Smoke m... Class II Konica Minolta Medical Imaging USA, Inc.
Dec 4, 2017 Sonimage HS1 Ultrasound Kit AC adapter, Product Number: 1. A9RP, UDI: 0456014... There is a risk of circuit board breakage within the main housing of the AC Adapter unit. Smoke m... Class II Konica Minolta Medical Imaging USA, Inc.
Dec 4, 2017 Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8AR, UDI: 0456014194... There is a risk of circuit board breakage within the main housing of the AC Adapter unit. Smoke m... Class II Konica Minolta Medical Imaging USA, Inc.
Dec 1, 2017 Gas Module 3 monitoring spirometer, Part Number: 115-030108-00 Product Usa... The firm made multiple changes to the product requiring the submission of a new 510(k) premarket ... Class III Mindray DS USA, Inc. dba Mindray North America
Nov 27, 2017 DERMABOND" PRINEO" Skin Closure System Product Usage: DERMABOND PRINEO ... Ethicon discovered that specific lots of DERMABOND"PRINEO"System may not dry within the specified... 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.