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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

39,949 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 39,949 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 39,949 FDA device recalls.

DateProductReasonClassFirm
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1961 Some foil pouches were found torn open, impacting the sterile barrier which was traced to a speci... Class II Ethicon Sarl, a Johnson & Johnson Company
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Numb... A customer found product with incomplete seals of P/N 20400161S, lot #185198 which can lead to no... Class II Canadian Hospital Specialties Ltd.
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 10, 2024 BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144 Pneumonia panels have an increased risk of control failures due to an issue in the manufacturing ... Class II BioFire Diagnostics, LLC
Jun 10, 2024 BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143 Pneumonia panels have an increased risk of control failures due to an issue in the manufacturing ... Class II BioFire Diagnostics, LLC
Jun 7, 2024 AURORA Surgiscope System. Sterile, single use device that contains a Sheath, ... Potential sheath damage that could lead to tissue damage and/or track hemorrhage. Class II Integra LifeSciences Corp.
Jun 7, 2024 RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) us... Cystatin C Reagent marketed without a 510 (k) Class II Randox Laboratories Ltd.
Jun 7, 2024 smiths medical portex BLUgriggs Percutaneous Dilation Procedural Trays with B... There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation l... Class I Smiths Medical ASD Inc.
Jun 7, 2024 smiths medical portex BLUperc Percutaneous Diliation Procedural Trays with BL... There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation l... Class I Smiths Medical ASD Inc.
Jun 7, 2024 smiths medical portex BLUselect, tracheostomy tube, labeled as follows: 1) ... There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation l... Class I Smiths Medical ASD Inc.
Jun 7, 2024 OMTech Desktop Laser Engraver Lack of redundant interlocks, missing required labels and certification labels as required by 21 ... Class II Rygel Advanced Machines d/b/a Omtech Laser
Jun 5, 2024 SENSE XL TORSO COIL 1.5T Mk2. 16-element receive only coil for torso and abdo... Potential for coils to heat up and harm patients (burn). Class I Philips North America Llc
Jun 5, 2024 Synergetics I Pack Injection Kit- Tray for use with Ophthalmic injections ... Could not confirm products were exposed to the proper sterilization cycle can potentially cause p... Class II MICROspecialties, Inc.
Jun 5, 2024 Synergetics I Pack Injection Kit with Wire Speculum- Tray for use in Opthalm... Could not confirm products were exposed to the proper sterilization cycle can potentially cause p... Class II MICROspecialties, Inc.
Jun 5, 2024 Synergetics I-Pack Injection Kit with Drape -For use with Ophthalmic injecti... Could not confirm products were exposed to the proper sterilization cycle can potentially cause p... Class II MICROspecialties, Inc.
Jun 5, 2024 Synergetics I Pack Injection Kit Custom-Tray for use with Ophthalmic injectio... Could not confirm products were exposed to the proper sterilization cycle can potentially cause p... Class II MICROspecialties, Inc.
Jun 5, 2024 SENSE XL TORSO COIL 3.0T. 16-element receive only coil for torso and abdomen ... Potential for coils to heat up and harm patients (burn). Class I Philips North America Llc
Jun 5, 2024 SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen ... Potential for coils to heat up and harm patients (burn). Class I Philips North America Llc
Jun 5, 2024 DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemist... There are two software bug issues with the analyzer. Issue 1: When a dedicated rack is reserved f... Class II Beckman Coulter Mishima K.K.
Jun 4, 2024 Zyno Medical Z800, Z800F, Z800W, and Z800WF Infusion Pumps Zyno Medical has found that certain Z800, Z800F, Z800W, and Z800WF pumps have faulty power supply... Class II Zyno Medical LLC
Jun 4, 2024 Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137. The analyzers were built with nonconforming USB cables made with brass contacts instead of specif... Class II Beckman Coulter, Inc.
Jun 4, 2024 VidiaPort carrying arm, mount for auxiliary products, model numbers: a) 40... Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer repo... Class II Baxter Healthcare Corporation
Jun 4, 2024 iLED 7 surgical lights, Model Numbers: a) 4068110 (Ceiling Single Surgical... Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer repo... Class II Baxter Healthcare Corporation
Jun 4, 2024 Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/... Insufficient weld around the cap component of the instrument is insufficient to withstand impact... Class II SEASPINE ORTHOPEDICS CORPORATION
Jun 4, 2024 Trulight 5000/3000 Surgical Light, model numbers: a) 4038210 (Duo Surgical... Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer repo... Class II Baxter Healthcare Corporation
Jun 3, 2024 Transfer Device, REF 2008S. Packaged on a form, fill and seal machine with a ... During sterile barrier testing performed on the decanter product line, the samples were identifie... Class II Microtek Medical Inc.
Jun 3, 2024 C-Flow Bag Decanter, REF 2000S. Packaged on a form, fill and seal machine wit... During sterile barrier testing performed on the decanter product line, the samples were identifie... Class II Microtek Medical Inc.
Jun 3, 2024 RTL190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Mode... An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) a... Class II Fresenius Medical Care Holdings, Inc.
Jun 3, 2024 Bottle Decanter, REF 2004S. Packaged on a form, fill and seal machine with a ... During sterile barrier testing performed on the decanter product line, the samples were identifie... Class II Microtek Medical Inc.
Jun 3, 2024 191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - Blood Pump Rotor spare part, ... An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) a... Class II Fresenius Medical Care Holdings, Inc.
Jun 3, 2024 Curved, super elastic cement delivery needle that passes through the cannula ... Expired Products distributed to customers Class II Stryker Corporation
Jun 3, 2024 This product is a single use sterile device that is used to direct the lesion... Expired Products distributed to customers Class II Stryker Corporation
Jun 3, 2024 Vial Decanter, REF 2006S. Packaged on a form, fill and seal machine with a po... During sterile barrier testing performed on the decanter product line, the samples were identifie... Class II Microtek Medical Inc.
Jun 3, 2024 Bag Decanter II, REF 2002S. Packaged on a form, fill and seal machine with a ... During sterile barrier testing performed on the decanter product line, the samples were identifie... Class II Microtek Medical Inc.
Jun 3, 2024 RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare p... An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) a... Class II Fresenius Medical Care Holdings, Inc.
Jun 3, 2024 190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model N... An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) a... Class II Fresenius Medical Care Holdings, 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.