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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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Bridge Safety624,000 bridge inspections Aviation Safety30,000+ NTSB aviation events Dam Safety92,600 dam safety records Water Safety433,000+ public water systems Railroad Safety438,000+ rail crossings Pipeline Safety8,800+ pipeline incidents State DashboardsSafety grades for all 50 states ZIP ReportAny 5-digit ZIP across 9 datasets

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Browse Device Recalls

5,428 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,428 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 5,428 FDA device recalls.

Clear
DateProductReasonClassFirm
Apr 4, 2016 5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm Sterile; Catalog ID #... This lot of the 5.0 mm Periprosthetic Locking Screw, Self-tapping, 12mm Sterile, was shipped afte... Class II Synthes (USA) Products LLC
Apr 4, 2016 iConnect Enterprise Archive (ICEA) software. The firm name on the labeling i... An error message can occur resulting in the prior studies being unavailable for viewing. Class II Merge Healthcare, Inc.
Apr 4, 2016 Merge Hemo software. The firm name on the labeling is Merge Healthcare, Hart... Use of the software may show an incorrect value to the user when viewing the Fractional Flow Rese... Class II Merge Healthcare, Inc.
Mar 31, 2016 Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit; Catalog... Biocare Medical has identified a single lot (082715) of its Mach 4 HRP Polymer kit in which some ... Class III Biocare Medical, LLC
Mar 30, 2016 Pleur-evac Chest Drainage System, Dry Suction/Dry Seal Control, REF A-6000-08... The label on the Tyvek bag is missing. This is used by customers to identify material code, lot ... Class II Teleflex Medical
Mar 29, 2016 ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, S... Medtronic is conducting a voluntary Urgent Medical Device Recall of two lots of the PowerCross 0.... Class II ev3, Inc.
Mar 28, 2016 Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and ... Eye Station images were not importing properly and were imported under "unknown" due to an issue ... Class II Merge Healthcare, Inc.
Mar 28, 2016 Boston Scientific, PT Graphix Magnet J-TIP Guidewire with ICE Hydrophilic Co... Boston Scientific is voluntarily implementing a Medical Device Recall of one batch of PT Graphix ... Class II Boston Scientific Corporation
Mar 24, 2016 Weck EFx Classic Fascial Closure System, Rx Only, Sterile, The product is ... Incorrect expiration date was printed on the product label. Class II Teleflex Medical
Mar 23, 2016 Nutrient Gelatin, Acumedia Part Number 7471 A Product Usage: Nutrient Gel... Incorrect expiration date was listed on the label. Correct expiration date was November 30, 2016.... Class III Acumedia Manufacturers, Inc.
Mar 21, 2016 SurgiCounter scanner, part of the SurgiCount Safety-Sponge System. Model nu... The affected scanner does not correctly interact with the SC360 software. When docked pre/postope... Class II Stryker Instruments Div. of Stryker Corporation
Mar 18, 2016 Boston Scientific Ultraflex Tracheobronchial Distal Release Stent System 12mm... Mislabeled: 10mm diameter x 30mm length Ultraflex Tracheobronchial stents were labeled as 12mm di... Class II Boston Scientific Corporation
Mar 18, 2016 BD-Retic-Count Reticulocyte Reagent System; Hematology: Used for in vitro ... The carton label for one lot of BD Retic-Count Reticulocyte Reagent System had the incorrect stor... Class III Becton, Dickinson and Company, BD Biosciences
Mar 17, 2016 Medtronic Navigation O-arm 02 surgical x-ray imaging system Review of on-system electronic product labeling and Instr uctions for Use in response to an inter... Class II Medtronic Navigation, Inc.-Littleton
Mar 15, 2016 Boston Scientific TSX Transseptal Needle, Model Number M004TSX60o; Used to c... Merit Medical Systems, Inc. is voluntarily conducting a recall of one lot of the TSX" Transseptal... Class II Merit Medical Systems, Inc.
Mar 14, 2016 Vaxcel PICC with PASV MST-30 Kit under the following labels: 1) 4F, UPN M0014... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... Class II Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016 Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... Class II Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016 Vaxcel PICC with PASV IR-145 Kit under the following labels: 1) 4F, UPN M0014... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... Class II Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016 Vaxcel PICC with PASV Intermediate Safety MST Kit under the following labels:... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... Class II Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016 Vaxcel PICC with PASV MST-60 Kit under the following labels: 1) 3F, UPN H9654... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... Class II Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016 Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... Class II Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016 Vaxcel PICC with PASV Catheter Kit under the following labels: 1) 3F, UPN H96... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... Class II Navilyst Medical, Inc., an AngioDyamics Company
Mar 10, 2016 Poly-bags containing the strap labeled with "Adult" sticker. Each strap ki... On March 9, 2016, the firm was contacted regarding the possibility of incorrect labeling on the o... Class II Ferno-Washington Inc
Mar 10, 2016 Poly-bags containing splint strap labeled with "Pediatric" sticker. Each s... On March 9, 2016, the firm was contacted regarding the possibility of incorrect labeling on the o... Class II Ferno-Washington Inc
Mar 7, 2016 Estradiol III; Elecsys and cobas e analyzers; REF 06656021 190; M 6.5 mL, R1 ... Due to the risk of a recently identified cross reactivity, the Elecsys Estradiol assay should not... Class II Roche Diagnostics Operations, Inc.
Mar 7, 2016 Estradiol II Elecsys and cobas e analyzers REF 03000079 190; M 6.5mL, R1 8 ... Due to the risk of a recently identified cross reactivity, the Elecsys Estradiol assay should not... Class II Roche Diagnostics Operations, Inc.
Mar 3, 2016 TOPAZ MicroDebrider 0.8 mm REF AC4040-01; TOPAZ MicroDebrider IFS 0.8 mm REF ... During functional testing of devices after real time aging, it was determined that product failed... Class II ArthroCare Corporation
Mar 3, 2016 dynarex Specimen Containers, Screw-On, Leak-Resistant Lid, Tamper-Evident Sea... Exterior carton is mis-labeled as Sterile. Non-sterile, bulk specimen containers were packed in ... Class II Dynarex Corporation
Mar 2, 2016 IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK PF PINK... Possible presence of foreign material (rust). Class II CMP Industries, Llc
Feb 29, 2016 Gomco Style Circumcision Clamp Trays is an instrument used to compress the fo... Two lots of Gomco Style Circumcision Clamp Trays, SSI-0034 and 10-1100 contained a 1.3cm circumci... Class II Cardinal Health
Feb 24, 2016 PureWick External Catheter for Women-Wick Product Usage: A flexible, con... PureWick is recalling external catheter for women Wicks because the labeling did not contain the ... Class II Purewick Corporation
Feb 22, 2016 Molteno3 Glaucoma Implants G-Series: GS-Single Plate 175mm2 (IOP reorder#:... Innovative Ophthalmic Products (IOP) is recalling the Molteno 3 G-Series Glaucoma Implant the pac... Class II Innovative Ophthalmic Products, Inc
Feb 19, 2016 Apollo EZ: Model: 9784152036 Multi-function x-ray systems capable of routi... The analysis showed that the incident was caused by a chain of four faults: 1.) The injured pers... Class II Villa Radiology Systems LLC
Feb 19, 2016 Apollo DRF: Model: 9784220831 Multi-function x-ray systems capable of rout... The analysis showed that the incident was caused by a chain of four faults: 1.) The injured pers... Class II Villa Radiology Systems LLC
Feb 19, 2016 Juno DRF; Model: 709020 Multi-function x-ray systems capable of routine ra... The analysis showed that the incident was caused by a chain of four faults: 1.) The injured pers... Class II Villa Radiology Systems LLC
Feb 19, 2016 Apollo: Models: 9784000131, 9784000231, 9784020131, 9784020231, 9784100231, 9... The analysis showed that the incident was caused by a chain of four faults: 1.) The injured pers... Class II Villa Radiology Systems LLC
Feb 18, 2016 Oblique Posterior Atraumatic Lumbar (OPAL) System, Polymeric spinal fusion ca... The label on the outer packaging does not match the product inside and intended use of the device. Class II Synthes (USA) Products LLC
Feb 17, 2016 EZ adjust aluminum crutch under the following labels: 1) EZ adjust aluminum c... Tip crutch failure involving the bottom of the metal portion which comes in contact with ground Class II Medical Depot Inc.
Feb 17, 2016 Aluminum crutch under the following labels: 1) Aluminum crutch, adult, 1 pair... Tip crutch failure involving the bottom of the metal portion which comes in contact with ground Class II Medical Depot Inc.
Feb 17, 2016 Universal Quick Adjust under the following labels: 1) Aluminum crutch, adult,... Tip crutch failure involving the bottom of the metal portion which comes in contact with ground Class II Medical Depot Inc.
Feb 17, 2016 Universal Quick Adjust under the following labels: 1) Aluminum crutch, adult,... Tip crutch failure involving the bottom of the metal portion which comes in contact with ground Class II Medical Depot Inc.
Feb 16, 2016 4.0 mm Cortex Screw, Product code HWC, Device Listing Number D137404 and D137... Labeling does not match the cleared indications for use in the United States and Canada. Class II Synthes (USA) Products LLC
Feb 16, 2016 3.5 mm and 4.0 mm Cannulated Screw, Product code HWC, Device Listing Number D... Labeling does not match the cleared indications for use in the United States and Canada. Class II Synthes (USA) Products LLC
Feb 16, 2016 6.5 mm Cancellous Screw, Product code HWC, Device Listing Number D029043, Scr... Labeling does not match the cleared indications for use in the United States and Canada. Class II Synthes (USA) Products LLC
Feb 16, 2016 7.0 mm and 7.3 mm Cannulated Screw, Product code HWC, Device Listing Number D... Labeling does not match the cleared indications for use in the United States and Canada. Class II Synthes (USA) Products LLC
Feb 16, 2016 6.5 mm Cannulated Screw, Product code HWC, Device Listing Number D028949, Scr... Labeling does not match the cleared indications for use in the United States and Canada. Class II Synthes (USA) Products LLC
Feb 16, 2016 4.5 mm Cortex Screw, Product code HWC, Device Listing Number D137402, Screw, ... Labeling does not match the cleared indications for use in the United States and Canada. Class II Synthes (USA) Products LLC
Feb 16, 2016 4.5 mm Cannulated Screw, Product code HWC, Device Listing Number D029092 and ... Labeling does not match the cleared indications for use in the United States and Canada. Class II Synthes (USA) Products LLC
Feb 12, 2016 10mm X 12o Solitaire Ti Medium Spacer  Solitaire Anterior Spinal System, Mod... Zimmer Biomet Spine initiated a recall of certain Solitaire Ti Spacers because they may have a mi... Class II Biomet Spine, LLC
Feb 11, 2016 KAMRA Inlay, ACI 7000 Corneal Inlay, Part No. 76195-01 and 76195-10 (OUS) ... AcuFocus is recalling KAMRA ACI 7000 Corneal Inlays due to concerns with the labeled shelf life. Class II AcuFocus, 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.