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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
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
Jul 3, 2012 Fona Srl IntraOs 70 intra-oral x-ray system IntraOS 70 is an extra oral so... The IntraOs 70 system was found to have missing or incomplete system labels as required by 21 CFR... Class II Chicago X-Ray Systems, Inc.
Jun 29, 2012 MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporat... The MXR-35 X-ray Generator's labeling did not include the certification statement as required by ... Class II Fujifilm Medical System USA, Inc.
Jun 28, 2012 STERRAD Cyclesure Biological Indicator (BI), P/N 14324 are sold in cases, pac... Advanced Sterilization Products (ASP) is recalling certain lots of the STERRAD CYCLESURE 24 Biolo... Class II Advanced Sterilization Products
Jun 26, 2012 GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal... Disposable T-Piece circuits used with resuscitation systems are unable to achieve maximum Peak In... Class I GE Healthcare, LLC
Jun 20, 2012 System 8000 Base Product Usage: The Sarns Modular Perfusion System 8000 ... During a retrospective review of complaint events, TCVS identified on 06/15/12 that three (3) Sa... Class III Terumo Cardiovascular Systems Corporation
Jun 18, 2012 MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for ... Synthes is initiating a Medical Device Labeling Correction following a detailed review of the cur... Class II Synthes USA HQ, Inc.
Jun 15, 2012 AngioDynamics Angiographic catheter --- Soft-Vu (JB-1) Non-braided. --- Size:... AngioDynamics is recalling one lot of Soft-Vu Angiographic catheters because one of the catheter ... Class II Angiodynamics Worldwide Headquarters
Jun 15, 2012 Equinoxe Reverse Shoulder Fracture Adapter Tray Screw Intended for Primary... Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinox... Class II Exactech, Inc.
Jun 15, 2012 Equinoxe Reverse Compression Screw Intended for Primary and Reverse Total ... Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinox... Class II Exactech, Inc.
Jun 15, 2012 Equinoxe Anatomic Replicator Plate Intended for Primary and Reverse Total ... Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinox... Class II Exactech, Inc.
Jun 15, 2012 Equinoxe Reverse Glenosphere Locking Screw Intended for Primary and Revers... Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinox... Class II Exactech, Inc.
Jun 15, 2012 Equinoxe Fixed Angle Replicator Plate Intended for Primary and Reverse Tot... Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinox... Class II Exactech, Inc.
Jun 15, 2012 Octane-C Cervical, 6¿ Lordotic Intended for anterior cervical spine interver... Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinox... Class II Exactech, Inc.
Jun 14, 2012 OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compressi... The device is a Left 8 hole plate but is incorrectly labeled and etched as a Right device. Class II OrthoPediatrics Corp
Jun 8, 2012 NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system... One of the four screws that secure the Oil-accumulator to the X-Ray Tube pulled out in the NeuViz... Class II Philips And Neusoft Medical Systems Co., Ltd.

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.