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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

2,057 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 19, 2023 Integra Cranial Access Kit- For access to the subarachnoid space or the later... Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split withou... Class II Integra LifeSciences Corp.
Oct 19, 2023 Integra Cranial Access Kit-For access to the subarachnoid space or the latera... Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split withou... Class II Integra LifeSciences Corp.
Oct 19, 2023 Integra Cranial Access Kit -For access to the subarachnoid space or the later... Defect in the outer packaging of the Cranial Access Kits can cause the packaging to split without... Class II Integra LifeSciences Corp.
Oct 19, 2023 Integra¿ Cranial Access Kit-For access to the subarachnoid space or the later... Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split withou... Class II Integra LifeSciences Corp.
Oct 19, 2023 Integra Cranial Access Kit-For access to the subarachnoid space or the latera... Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split withou... Class II Integra LifeSciences Corp.
Oct 19, 2023 Integra Cranial access kit (without Prep solutions) Bit and Guard-For access ... Defect in the outer packaging of the Cranial Access Kits can cause the packaging to split without... Class II Integra LifeSciences Corp.
Oct 19, 2023 Integra Cranial Access Kit - For access to the subarachnoid space or the late... Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split withou... Class II Integra LifeSciences Corp.
Oct 12, 2023 Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbe... It was found that the fixation (weld) employed by the supplier of the nut bolt to the slide rail ... Class II Maquet Medical Systems USA
Oct 11, 2023 BD Alaris Pump infusion sets (Product Name, Catalog #) BD AlarisTM Pump In... Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DE... Class II Becton Dickinson & Company
Oct 11, 2023 BD Extension Sets (Product Name, Catalog #) BD SmartSite Filter Extension ... Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DE... Class II Becton Dickinson & Company
Oct 11, 2023 BD gravity sets (Product Name, Catalog #) 32-IN GRAV SET W/0.2 MICRON FILT... Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DE... Class II Becton Dickinson & Company
Oct 10, 2023 CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOH... Product removal due to possible blocking or impairment of the CARDIOHELP Emergency Drive. This is... Class I Maquet Medical Systems USA
Oct 5, 2023 CereLink ICP Extension Cable (Extension Cable), Model No. 826845 Used with... Firm is expanding the existing recall RES 90457 for the Cerelink, initiated in June 2022, to incl... Class I Integra LifeSciences Corp.
Sep 22, 2023 DBX Demineralized Bone Matrix Putty 10cc-Indicated for treatment of surgicall... Units are labeled as 10cc; however the units have a fill volume of 1cc units. This may result in ... Class II Musculoskeletal Transplant Foundation, Inc.
Sep 19, 2023 Vasoview 6 Pro (VV6) - Endoscopic Vessel Harvesting System, Model VH-2400 pri... Device packaged inside an incorrect outer box; displaying artwork & illustrations for a different... Class II Maquet Cardiovascular, LLC
Sep 13, 2023 Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance... Housing Mount Jaw of these devices breaking during normal use and may result in injury to the epi... Class II Maquet Cardiovascular, LLC
Sep 6, 2023 Meera Mobile Operating Table-to support and position the patient immediately ... Under certain conditions, an issue might prevent the device from performing as intended. A specif... Class II Getinge Usa Sales Inc
Sep 1, 2023 Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-0... Potential for breach of Tyvek seals. Class II Onkos Surgical, Inc.
Sep 1, 2023 Male-Female Midsection with the following sizes and model numbers. a. Male... Potential for breach of Tyvek seals. Class II Onkos Surgical, Inc.
Sep 1, 2023 Segmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Numbers: CB-11152-03M, ... Potential for breach of Tyvek seals. Class II Onkos Surgical, Inc.
Sep 1, 2023 Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Numb... Device reaching End of Service prematurely. Class II Angel Medical Systems, Inc.
Sep 1, 2023 Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-111... Potential for breach of Tyvek seals. Class II Onkos Surgical, Inc.
Sep 1, 2023 Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-0... Potential for breach of Tyvek seals. Class II Onkos Surgical, Inc.
Sep 1, 2023 a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100... Potential for breach of Tyvek seals. Class II Onkos Surgical, Inc.
Aug 25, 2023 Detector H. Pylori, Catalog Number IHP-30 Labeling for affected lots incorrectly indicates the expiration date is 10/31/2023. However, the ... Class II Immunostics, Inc.
Aug 10, 2023 Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Mo... A software update corrected an issue where "low" and "terminal" battery alerts did not display on... Class II Turncare, Inc
Jul 31, 2023 Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080... Users were experiencing a failure in the IAB Fiber Optic Sensor input on the IABP when inserting ... Class II Datascope Corp.
Jul 31, 2023 Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080... Users were identifying autofill failure conditions on the devices causing pump stops. Class I Datascope Corp.
Jul 31, 2023 Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080... Users were reporting instances of "Gas Loss in IAB Circuit" and "Gas Gain in IAB Circuit" alarms ... Class I Datascope Corp.
Jul 31, 2023 Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080... Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Card... Class I Datascope Corp.
Jul 31, 2023 Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080... Users were experiencing a failure in the IAB Fiber Optic Sensor input on the IABP when inserting ... Class II Datascope Corp.
Jul 31, 2023 Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080... Users were identifying autofill failure conditions on the devices causing pump stops. Class I Datascope Corp.
Jul 31, 2023 Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080... Users were reporting that the device was not charging as expected. It was discovered that users w... Class I Datascope Corp.
Jul 31, 2023 Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080... Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Card... Class I Datascope Corp.
Jul 31, 2023 Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080... Users were reporting instances of "Gas Loss in IAB Circuit" and "Gas Gain in IAB Circuit" alarms ... Class I Datascope Corp.
Jul 31, 2023 Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080... Users were reporting that the device was not charging as expected. It was discovered that users w... Class I Datascope Corp.
Jul 21, 2023 Keystone Bosworth Copaliner Cavity Varnish .5oz (14 ml)- Intended to provide ... A bottle of Copaliner Solvent was inadvertently packaged into a box labeled as Copaliner Varnish ... Class II Keystone Industries
Jun 28, 2023 ACROBAT V Vacuum Off-Pump System, Part Number C-OM-9100S. Component of a ches... The Standard Blade may not securely latch onto the Activator Drive. This may result in the inabil... Class II Maquet Cardiovascular, LLC
Jun 28, 2023 ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a ch... The Standard Blade may not securely latch onto the Activator Drive. This may result in the inabil... Class II Maquet Cardiovascular, LLC
Jun 28, 2023 ACCESSRAIL Platform (Standard Blade) Part Number SB-1000, and (Deep Blades) P... The Standard Blade may not securely latch onto the Activator Drive. This may result in the inabil... Class II Maquet Cardiovascular, LLC
Jun 28, 2023 ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a c... The Standard Blade may not securely latch onto the Activator Drive. This may result in the inabil... Class II Maquet Cardiovascular, LLC
Jun 23, 2023 SENSATION PLUS 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used ... During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body o... Class II Datascope Corp.
Jun 23, 2023 MEGA 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide... During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body o... Class II Datascope Corp.
Jun 23, 2023 REINFORCED INTRODUCER SET, Intra-Aortic Balloon Catheter and Accessories, use... During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body o... Class II Datascope Corp.
Jun 23, 2023 MEGA 7.5Fr.IAB , Intra-Aortic Balloon Catheter and Accessories, used to provi... During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body o... Class II Datascope Corp.
Jun 23, 2023 TRANS-RAY IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide... During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body o... Class II Datascope Corp.
Jun 23, 2023 SENSATION PLUS 7.5Fr IAB, Intra-Aortic Balloon Catheter and Accessories, used... During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body o... Class II Datascope Corp.
Jun 23, 2023 YAMATO PLUS IAB; intra-aortic balloon catheter and accessories used to provid... During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body o... Class II Datascope Corp.
Jun 23, 2023 SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to p... During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body o... Class II Datascope Corp.
Jun 23, 2023 LINEAR 7.5Fr.IAB, Intra-Aortic Balloon Catheter and Accessories, used to prov... During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body o... Class II 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.