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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.

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DateProductReasonClassFirm
Dec 8, 2015 Perkin Elmer WIZARD2 10-detector, 550 samples Product Code: 2470-0100, 3470-0... The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The... Class II Perkinelmer
Dec 8, 2015 SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name... It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post... Class II Synthes (USA) Products LLC
Dec 8, 2015 SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name... It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post... Class II Synthes (USA) Products LLC
Dec 8, 2015 SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name... It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post... Class II Synthes (USA) Products LLC
Dec 7, 2015 Excella II Rod Cat. No.: SR 55100 5.5 x 100 mm LOT 1502 and Excella II Rod ... Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's la... Class II Innovasis, Inc
Dec 4, 2015 Synaptive Medical BrightMatter Navigator System (Guide System). Part number S... Out of tolerance for radio frequency emissions. At the 150-1000MHz frequency, the testing indicat... Class II Synaptive Medical, Inc.
Dec 3, 2015 Gynecare Thermachoice III Uterine Balloon Therapy System Ethicon, Inc. The... Stability data does not substantiate the labeled two-year shelf life of affected product. Class II Ethicon, Inc.
Dec 3, 2015 NexGEN System REF 5980-37-01 Tibial Component Size Stemmed 3 Precoat, and RE... A product complaint was received stating that a carton labeled as a Precoat Stemmed Tibia Size 3 ... Class II Zimmer Manufacturing B.V.
Dec 2, 2015 Label reading in part as: "NexGen System, Complete Knee Solution; Reference N... Complaints were received from Thailand reporting that there was no white paper (Tyvek) seal on th... Class II Zimmer Manufacturing B.V.
Dec 1, 2015 3M Coban Self-Adherent Wrap Shipper carton label identified the product as 3M... Product mislabeled as latex free. Actual Catalog number 1581, lot 2020-10AN. contains latex. Thi... Class II 3M Company - Health Care Business
Nov 30, 2015 Columbus Revision Knee System, EnduRo Knee System Product Usage: The Colu... Aesculap Inc. US has initiated a recall on Tibial and Femur extension sterile pressfit stem impla... Class II Aesculap, Inc.
Nov 25, 2015 Battery Power Line II Battery Oscillator, DePuy Synthes Power Tools, The Ansp... Has the incorrect operating directions on the mode switch ring, i.e. its is labeled "FWD, LOCK, R... Class II The Anspach Effort, Inc.
Nov 20, 2015 FMS neXtra¿ 3.5mm Full Radius Cutter Shaver Blades; Product Code: 283305 ... Product is incorrectly labeled. The blade configuration in the affected lots does not match the d... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Nov 20, 2015 WARM STEAM Personal Steam Inhaler-Adjustable control to regulate flow of stea... "The public reason for the recall is that the product is being recalled out of an abundance of ca... Class II Bigwall Enterprises
Nov 20, 2015 FMS 3.5mm Ultra-Aggressive Cutter Shaver Blades; Product Code: 287325 Inte... Product is incorrectly labeled. The blade configuration in the affected lots does not match the d... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Nov 20, 2015 FMS neXtra¿ 3.5mm Aggressive Cutter Shaver Blades; Product Code: 283315 In... Product is incorrectly labeled. The blade configuration in the affected lots does not match the d... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Nov 19, 2015 VentriClear¿ II Ventricular Drainage Catheter Set. Allows external access an... Cook Medical initiated a voluntary recall of specific lot numbers of the VentriClear II Ventricul... Class II Cook Inc.
Nov 18, 2015 Dressit-X, Radiopaque D-545, NDC 11004-545-40, Dental Use Only, Active Ingred... Rainbow Specialty & Health Products initiated a field action for Dressol-X and Dressit-X because ... Class II Rainbow Specialty & Health Products
Nov 18, 2015 Dressol-X, Radiopaque D-502, NDC 11004-502-40, Dental Use Only, Active Ingred... Rainbow Specialty & Health Products initiated a field action for Dressol-X and Dressit-X because ... Class II Rainbow Specialty & Health Products
Nov 17, 2015 Merge RadSuite software. The firm name on the label is Merge Healthcare, Har... The values provided from the Pixel Value tool do not appear to be correct, which may result in po... Class II Merge Healthcare, Inc.
Nov 17, 2015 Biomet Integral Centralizer Hip System, Lateralized Femoral Stem (Co-Cr-Mo), ... PMMA is listed as a material on the label but the product does not contain PMMA. Class II Biomet, Inc.
Nov 16, 2015 Sodium Chloride Inhalation Solution, USP 7%, 60 x 4 mL Sterile Unit-Dose Vial... Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the ... Class II Nephron Pharmaceuticals Corp.
Nov 16, 2015 BIRMINGHAM HIP RESURFACING MODULAR HEAD, REF numbers: 74121238, MODULAR HE... The 16 devices distributed in the United States were incorrectly labeled as the monoblock Birming... Class II Smith & Nephew, Inc.
Nov 16, 2015 Sodium Chloride Inhalation Solution, USP 3%, 60 x 4 mL Sterile Unit-Dose Vial... Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the ... Class II Nephron Pharmaceuticals Corp.
Nov 12, 2015 Digital Temple Thermometer labeled under: Bestmed, Good Neighbor (Amerisource... An incorrect calibration of the thermometer that causes the device to display inaccurate and freq... Class II Bestmed, LLC
Nov 11, 2015 Siemens Acute Care CTNI TestPak-in vitro diagnostic test for the measurement... Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class II Siemens Healthcare Diagnostics Inc
Nov 11, 2015 Siemens Acute Care BHCG TestPak-an in vitro diagnostic product intended to be... Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class II Siemens Healthcare Diagnostics Inc
Nov 11, 2015 Siemens Acute Care BHCG CalPak-in vitro diagnostic product intended to be use... Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class II Siemens Healthcare Diagnostics Inc
Nov 11, 2015 Siemens Acute Care CKMB TestPak- in vitro diagnostic test for the measuremen... Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class II Siemens Healthcare Diagnostics Inc
Nov 11, 2015 Siemens Acute Care CCRP CalPak-in vitro diagnostic product intended to be use... Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class II Siemens Healthcare Diagnostics Inc
Nov 11, 2015 Siemens Acute Care pBNP TestPak- in vitro diagnostic test for the quantitativ... Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class II Siemens Healthcare Diagnostics Inc
Nov 11, 2015 Siemens Acute Care" MYO TestPak-in vitro diagnostic test for the quantitative... Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class II Siemens Healthcare Diagnostics Inc
Nov 11, 2015 Siemens Acute Care MYO DilPak Catalog Number: CMYO-D SMN:10445081 in vitro... Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class II Siemens Healthcare Diagnostics Inc
Nov 11, 2015 Siemens Acute Care DDMR TestPak Catalog Number: CDDMRE SMN: 10701511 in ... Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class II Siemens Healthcare Diagnostics Inc
Nov 11, 2015 Siemens Acute Care CKMB DilPak- an in vitro diagnostic product intended to be... Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class II Siemens Healthcare Diagnostics Inc
Nov 11, 2015 Siemens Acute Care" CCRP TestPak-in vitro diagnostic product intended to be u... Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class II Siemens Healthcare Diagnostics Inc
Nov 9, 2015 Smith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR COMPONENT, RESURFACING ROUN... One lot of 35 mm patella implants is labeled as 32 mm. These implants have pegs which are spaced... Class II Smith & Nephew, Inc.
Nov 6, 2015 MicroCutter Xchange 30 Blue Curved Tip Cartridge. Model Number: FG-025321; T... Cardica, Inc. has received reports that use of the Blue Cartridges with the MicroCutter XCHANGE ... Class II Cardica, Inc.
Nov 6, 2015 Destination Renal Guiding Sheath Intended for the introduction of interven... Based on internal investigation and testing that revealed the distal end of certain lots of Terum... Class II Terumo Medical Corporation
Nov 4, 2015 Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part N... Ormco Corporation is recalling Copper NiTi Preformed Archwires because the product transformation... Class II Ormco/Sybronendo
Nov 3, 2015 NAMIC CONVENIENCE KIT RENOWN REGIONAL MEDICAL CENTER, REF Catalog No. 6523002... Procedure Products initiated the recall due to the inner lumen of the needles not meeting the int... Class II AngioDynamics Inc.
Oct 30, 2015 RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx ... An incorrect label reading 10.5mm and not the specified 15mm was placed on the implant inner ... Class II BioHorizons Implant Systems Inc
Oct 27, 2015 Thermo Scientific p21 WF1 Ab-3 (DCS-60.2) 1 ml (0.4mg/ml): Product code: MS... It was discovered that the labeling of MS-230 antibody incorrectly describes the concentration - ... Class III Lab Vision Corporation
Oct 26, 2015 PROLARYN Injectable Implant 1.0 cc Gel, Model No. 8602M0K5. A restorable impl... The expiration date encoded in the UDI barcode on the label on the product carton and the peelabl... Class II Merz North America, Inc.
Oct 26, 2015 Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1. Indicated fo... The expiration date encoded in the UDI barcode on the label on the product carton and the peelabl... Class II Merz North America, Inc.
Oct 26, 2015 MiniArc Pro Single incision Sling System, Model number / Product Reference 90... The lot number on the outer carton label did not match the lot number printed on the tray label o... Class II Astora
Oct 26, 2015 PROLARYN PLUS Injectable Implant 1.0 cc Plus Calcium Hydroxlyapatite (CaHA) I... The expiration date encoded in the UDI barcode on the label on the product carton and the peelabl... Class II Merz North America, Inc.
Oct 9, 2015 miraDry System consisting of the MD4000-MC Console, the MD4000-HP miraDry Han... Update to labeling for the miraDry Console to remind users to only use approved lubricants in a t... Class II Miramar Labs, Inc.
Oct 8, 2015 Merge OrthoCase software. The firm name on the label is Merge Healthcare, H... Measurements in the software are changing after saving a plan with a measurement result, which ma... Class II Merge Healthcare, Inc.
Oct 8, 2015 Easy Dial Oxygen Regulator, 168708D and 168715D. Eight liter from .0.25 t... These lots of Oxygen Dial Regulators could have the settings label off by one position. When the ... Class II Precision Medical, 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.