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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

5,543 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,543 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 5,543 FDA device recalls.

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DateProductReasonClassFirm
Sep 4, 2012 Anatomical Shoulder" Inverse/Reverse Glenoid Sterile, Rx Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Anatomical Shoulder" Inverse Humeral Cup Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Bard Ventralight ST Mesh. - Ellipse 8" x 10" (20.3 cm x 25.4 cm) Product Co... Mislabeled: The 8" x 10" package contains 7" x 9" VENTRALIGHT ST Mesh product and the 7" x 9" pa... Class II Davol, Inc., Subs. C. R. Bard, Inc.
Sep 4, 2012 zimmer Anatomical Shoulder Glenoid S, cemented, sterile; REF 01.04214.340 P... Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Biolox¿ Option Ceramic Femoral Head System Rx, sterile Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Anatomical Shoulder" Inverse/Reverse Humeral PE-Insert Sterile, Rx Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Alloclassic SL Shaft Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Anatomical Shoulder" Fracture Humeral stem Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 DTO" Implant Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 NCB¿ screw ¿ 4.0 self-tapping Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Dynesys¿ Top-Loading System Cannulated Pedicle + Set Screw Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Aug 30, 2012 ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 1... Lines on the screw gauge may not placed on the caddy properly which could result in improper meas... Class II Medtronic Sofamor Danek USA Inc
Aug 30, 2012 PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 E... Lines on the screw gauge may not placed on the caddy properly which could result in improper meas... Class II Medtronic Sofamor Danek USA Inc
Aug 30, 2012 ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-... Lines on the screw gauge may not placed on the caddy properly which could result in improper meas... Class II Medtronic Sofamor Danek USA Inc
Aug 27, 2012 Trilogy II Constrained Liner The Trilogy Longevity Constrained Liner ser... Trilogy Longevity Constrained Liner devices were packaged in incorrect cartons. The product is p... Class II Zimmer, Inc.
Aug 24, 2012 The brand name is MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Exten... Iradimed Corporation is recalling MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Extension... Class II Iradimed Corporation
Aug 23, 2012 Universal Flex2 Breathing Circuit Class I 510(k) Exempt An anesthesia b... King Systems received a customer complaint indicating that the customer had ordered a breathing c... Class I King Systems Corp.
Aug 22, 2012 S-Rom¿ Total Hip System Poly Liner Packaging: The insert is placed into ... Orthopaedics, Inc. (DePuy) is issuing a voluntary recall of four lots of the S-ROM" liner becaus... Class II DePuy Orthopaedics, Inc.
Aug 21, 2012 Oxoid Antimicrobial Susceptibility Discs, Cefoxitin 30ug REF CT0119B, package... The firm is recalling the product because the cartridges may contain discs that have an insuffici... Class II Remel Inc
Aug 15, 2012 0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 3 mL in 12 mL... One lot of 0.9% Sodium Chloride Flush syringe, 3 mL in 12 mL may be mislabeled as 0.9% Sodium Chl... Class III Amsino Medical USA
Aug 15, 2012 0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 10 mL in 12 m... One lot of 0.9% Sodium Chloride Flush syringe, 3 mL in 12 mL may be mislabeled as 0.9% Sodium Chl... Class III Amsino Medical USA
Aug 13, 2012 Progel Pleural Air Leak Sealant, Model #: PGPS002 Lot #: 111202-002 Produ... Product was distributed with an incorrect expiration date. Product was labeled with an expiratio... Class II Neomend Inc
Aug 10, 2012 IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase), Catalog Number IS-2800. Pac... It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are l... Class II Immunodiagnostics Systems Ltd
Aug 10, 2012 IDS-iSYS Intact PINP, Catalog Number IS-4000. Packaged in cardboard Box conta... It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are l... Class II Immunodiagnostics Systems Ltd
Aug 10, 2012 IDS-iSYS N-Mid¿ Osteocalcin, Catalog Number IS-2930. Packaged in cardboard Bo... It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are l... Class II Immunodiagnostics Systems Ltd
Aug 10, 2012 MyRay RXDC dental unit x-ray unit The RX DC dental x-ray unit was found to be noncompliant with 21CFR 1010,2, 1020.30(e) & 1020.30... Class II CEFLA DENTAL GROUP
Aug 10, 2012 IDS-iSYS Intact PINP Control Set, Catalog Number IS-4030. Packaged in cardboa... It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are l... Class II Immunodiagnostics Systems Ltd
Aug 10, 2012 IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase) Control Set, Catalog Number ... It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are l... Class II Immunodiagnostics Systems Ltd
Aug 10, 2012 QKC1692E The QKC1692E Quick Connect device connects endoscopes to the ste... STERIS has been actively seeking devices for quick connect revalidation projects. STERIS was una... Class II Steris Corporation
Aug 10, 2012 IDS Urine BETA CrossLaps ELISA, Catalog Number AC-05F1. Type of packaging: Ca... It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are l... Class II Immunodiagnostics Systems Ltd
Aug 10, 2012 IDS-iSYS N-Mid¿ Osteocalcin, Catalog Number IS-2900. Packaged in cardboard Bo... It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are l... Class II Immunodiagnostics Systems Ltd
Aug 9, 2012 3DKnee e+ Tibial Insert - HXLPE-VE, Sterile, Material: Highly cross linked vi... The firm is recalling one lot of 392-09-706, 3DKnee e+ Tibial insert, 9 mm, Size 6, Right. The s... Class II Encore Medical, Lp
Aug 2, 2012 PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test ... Customers were not following the labeled assay procedure. This was due to a letter issued to them... Class III Phadia US Inc
Jul 27, 2012 The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ B... An investigation of customer complaints identified that for two product lots, Left Horseshoe Gel ... Class II Integra Limited
Jul 27, 2012 The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ B... An investigation of customer complaints identified that for two product lots, Left Horseshoe Gel ... Class II Integra Limited
Jul 25, 2012 Philips Essenta DR, X-Ray System, Diagnostic, general-purpose Model: 712070.... Essenta DR C-Arm may fall Class II Philips Healthcare Inc.
Jul 24, 2012 Altrx" Altralinked" Polyethylene liners Description: An acetabular liner i... In the recalled lot, the products were not machined according to the production router, a size 52... Class II DePuy Orthopaedics, Inc.
Jul 20, 2012 TAUT, Cholangiogram Catheter Intraducer, Peritoneal Catheter, Teleflex Medica... Product is missing the label on the internal packaging. Class III Teleflex Medical
Jul 19, 2012 Laserworld RGB & Piko Nano RGB Models All models are laser light show proj... A potential lack of certification, and/or missing laser certification, laser safety warning and a... Class II Laserworld Usa Inc
Jul 17, 2012 13.5 mm x 50 mm BrainPath Sheath The NICO BrainPath is a family of product... BrainPath sheaths were mislabeled. Sheaths which measure 50mm were labeled as 60mm. The length c... Class II Nico Corp.
Jul 17, 2012 13.5 mm x 60 mm BrainPath Sheath The NICO BrainPath is a family of product... BrainPath sheaths were mislabeled. Sheaths which measure 50mm were labeled as 60mm. The length c... Class II Nico Corp.
Jul 17, 2012 Conformis iTotal CR-Cruciate Retaining Knee Replacement System Model Number... Addendum Labeling iTotal CR Surgical Technique with Detailed Instructions of Total CR Poly Insert... Class II Conformis Inc
Jul 16, 2012 djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for t... One lot of the 010-55-030, 6.5 mm Cancellous Bone Screw was recalled because a product complaint ... Class II Encore Medical, Lp
Jul 14, 2012 Smith & Nephew Dyonics Electroblade Resector, 4.5mm Full Radius Blade, BONECU... Devices labeled with an expiry period of 48 months instead of 36 months; an additional 12 months ... Class II Smith & Nephew, Inc. Endoscopy Division
Jul 14, 2012 Smith & Nephew 5.5 mm Dyonics Bonecutter ,Electroblade Full Radius Part Nu... Device labeled with an expiry period of 48 months instead of 36 months; an additional 12 months f... Class II Smith & Nephew, Inc. Endoscopy Division
Jul 13, 2012 Oto Ease by Westone, labeled as a bacteria free, greaseless lubricant. Sold ... Westone is recalling all Oto Ease ear lubricant in all packaging configurations and sizes due to ... Class II Westone Laboratories, Inc.
Jul 10, 2012 Caremor Cliner is labeled in part: "***Manufactured By Winco***Ocala, FL 344... Winco Mfg., LLC in Ocala, FL is recalling the Caremor Cliner model numbers 5351 and 5361. The rec... Class II Winco Mfg., LLC
Jul 6, 2012 PopLok Punch labeled in part: "PKL-35M***3.5mm***QTY 1***PopLok Punch***ConM... ConMed Linvatec recalled one lot of their PopLok bone Punch 3.5MM because the metal shaft diamete... Class II Linvatec Corp. dba ConMed Linvatec
Jul 5, 2012 ULTRA Fabric Reinforced surgical Gown X-Large Sterile The product is a ste... Package seam of some units may not remain properly sealed to ensure the contents might not be ste... Class II Kimberly-Clark Corporation
Jul 5, 2012 MicroCool Breathable Gown with Towels, X-Larg, X-Long, Sterile The product... Package seam of some units may not remain properly sealed to ensure the contents might not be ste... Class II Kimberly-Clark Corporation

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.