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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

3,164 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,164 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 3,164 FDA device recalls.

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DateProductReasonClassFirm
Nov 2, 2021 RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518 Potential for open packaging seals compromising the sterility of the surgical gowns Class II Cardinal Health
Nov 2, 2021 RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548 Potential for open packaging seals compromising the sterility of the surgical gowns Class II Cardinal Health
Sep 27, 2021 BD Syringe Tip Cap Bulk Sterile Convenience Pak-1000 units/shelf carton. Used... Holes in product packaging impacts package integrity and may compromise sterility. Class II Becton Dickinson & Company
Sep 10, 2021 FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 0... During a regular requalification review, affected flexible intubation video endoscopes did not ac... Class II Karl Storz Endoscopy
Aug 9, 2021 DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressin... There is a potential for open seals which can compromise sterility. Class II ConvaTec, Inc
Aug 5, 2021 Bone Marrow Transplantation biopsy needle Sterility assurance may be compromised. Class II M.D.L. S.r.l.
Aug 5, 2021 Aspirated Cyto-Histological Biopsy needle Sterility assurance may be compromised. Class II M.D.L. S.r.l.
Aug 5, 2021 General Manual surgical instrument Sterility assurance may be compromised. Class II M.D.L. S.r.l.
Aug 5, 2021 Mammary Nodules Localization Sterility assurance may be compromised. Class II M.D.L. S.r.l.
Aug 5, 2021 Soft Tissue Biopsy Needles Sterility assurance may be compromised. Class II M.D.L. S.r.l.
Jul 28, 2021 Corin Trinity Screw, diameter 6.5mm 35mm Length, Cancellous Bone Screw, REF 3... The packaging system on the devices have potential physical and water damage resulting in damage ... Class II Corin Ltd
Jul 28, 2021 Corin Trinity Dual Mobility, Size 4, Dual Mobility CoCr Liner, REF 321.04.540... The packaging system on the devices have potential physical and water damage resulting in damage ... Class II Corin Ltd
Jul 28, 2021 Corin Trinity Liner ECIMA, diameter 40mm Neutral Offset, Taper Size 4, REF 3... The packaging system on the devices have potential physical and water damage resulting in damage ... Class II Corin Ltd
Jul 28, 2021 Corin Trinity-i, diameter 50mm Taper Size 3, Non-Occluded Ti Plasma Shell, RE... The packaging system on the devices have potential physical and water damage resulting in damage ... Class II Corin Ltd
Jul 28, 2021 Corin Unity Knee Augments, Size 5, 6 & 7 / 10mm Thick, Femoral Posterior Augm... The packaging system on the devices have potential physical and water damage resulting in damage ... Class II Corin Ltd
Jul 28, 2021 Corin Unity Knee Patella, Size 3 / 8.5mm, Centered Dome 3 PEG-UHMWPE, REF 112... The packaging system on the devices have potential physical and water damage resulting in damage ... Class II Corin Ltd
Jul 28, 2021 Corin TriFit TS, Size 8, Standard Tapered Stem, REF 694.0008, Sterile. The packaging system on the devices have potential physical and water damage resulting in damage ... Class II Corin Ltd
Jul 28, 2021 Corin MetaFix Hip Stem, Size 1, Short Neck, 135 degrees, Collared Hip Stem, R... The packaging system on the devices have potential physical and water damage resulting in damage ... Class II Corin Ltd
Jul 28, 2021 Corin BIOLOX Delta Mod Head, diameter 28mm Medium 0mm, 12/14 Taper, REF 104.2... The packaging system on the devices have potential physical and water damage resulting in damage ... Class II Corin Ltd
Jul 28, 2021 Corin Unity Knee CS Insert, Size 5 / 9.0mm, Fixed Condylar Stabilised - UHMWP... The packaging system on the devices have potential physical and water damage resulting in damage ... Class II Corin Ltd
Jul 23, 2021 MIVI Super 90 Guide Catheters, MIVI Mi-Axus 8F Catheters, REF MIA-9080S (80 c... There is potential for nonsterility of product due to a possible defect in the pouch seal. Class II Mivi Neuroscience Inc
Jul 23, 2021 MIVI Super 90 8F Guide Catheter, 95 cm, REF MIA-9095S-IDE, For Investigationa... There is potential for nonsterility of product due to a possible defect in the pouch seal. Class II Mivi Neuroscience Inc
Jul 9, 2021 COPAN FLOQSwabs, STERILE.EO, for drawing clinical samples. CE0123, for the ... A sterility assurance level of 10-6 cannot be guaranteed due to intentional fraud and data integr... Class II Copan Italia
Jun 21, 2021 DELTAVEN Y, Safety I.V. Catheter in Pur with closed system a) REF 3832072 b... Problems related to the sterilization of the medical devices; possible missing sterility of the m... Class II Delta Med SpA
Jun 21, 2021 NEO DELTA SELFSAFE PUR 1, I.V. Catheter, REF 3718122 Problems related to the sterilization of the medical devices; possible missing sterility of the m... Class II Delta Med SpA
Jun 21, 2021 DELTAVEN FASTFLASH, Safety I.V. Catheter in Pur with closed system: a) REF 3... Problems related to the sterilization of the medical devices; possible missing sterility of the m... Class II Delta Med SpA
Jun 21, 2021 DELTAVEN Safety I.V. Catheter in Pur with closed system: a) REF 3836272 b) ... Problems related to the sterilization of the medical devices; possible missing sterility of the m... Class II Delta Med SpA
Jun 21, 2021 WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c)... Problems related to the sterilization of the medical devices; possible missing sterility of the m... Class II Delta Med SpA
Jun 21, 2021 NEO DELTA SELFSAFE PUR T, I.V. Catheter: a) REF 3738522 b) REF 3738822 Problems related to the sterilization of the medical devices; possible missing sterility of the m... Class II Delta Med SpA
Jun 21, 2021 DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 383257... Problems related to the sterilization of the medical devices; possible missing sterility of the m... Class II Delta Med SpA
Jun 21, 2021 NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 ... Problems related to the sterilization of the medical devices; possible missing sterility of the m... Class II Delta Med SpA
Jun 21, 2021 NEO DELTA SELFSAFE PUR T, I.V. Catheter: Problems related to the sterilization of the medical devices; possible missing sterility of the m... Class II Delta Med SpA
Jun 21, 2021 NEO DELTA Self Safe, I.V. Catheter REF 3738222 Problems related to the sterilization of the medical devices; possible missing sterility of the m... Class II Delta Med SpA
Jun 21, 2021 NEO DELTA Self Safe 1, I.V. Catheter with PUR REF 3708122, Lot 00A1160627 5... Problems related to the sterilization of the medical devices; possible missing sterility of the m... Class II Delta Med SpA
Jun 3, 2021 BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bu... Lack of Sterility Assurance; needle in procedure pack labeled as sterile may not have been adequ... Class II Axonics Modulation Technologies, Inc.
Apr 30, 2021 Medline Tissue Recovery Instrument Set, Reorder #DYNJ64347A, packaged 3/case,... The devices may not meet the minimum required sterility assurance level. Class II Medline Industries Inc
Apr 27, 2021 Quanta System Sterile Optical Laser Fiber, single use Product sterility is potentially compromised. Class II Quanta System, S.p.A.
Apr 27, 2021 Olympus Sterile Optical Laser Fiber, single use and reusable Product sterility is potentially compromised. Class II Quanta System, S.p.A.
Apr 27, 2021 Quanta System Sterile Optical Laser Fiber, reusable Product sterility is potentially compromised. Class II Quanta System, S.p.A.
Apr 26, 2021 REF 3987, SAFESCRAPER CURVE TWIST, CE 0123, STERILE EO. Used in oral surgery. Sterility issues; single use devices labeled as sterile may not have been adequately sterilized Class II Meta C.G.M. Spa
Apr 26, 2021 REF: 3598 SAFESCRAPER TWIST, CE 0123, STERILE EO. Used in oral surgery. Sterility issues; single use devices labeled as sterile may not have been adequately sterilized Class II Meta C.G.M. Spa
Apr 26, 2021 REF 4890 SMARTSCRAPER CE0123, STERILE EO. Used in oral surgery. Sterility issues; single use devices labeled as sterile may not have been adequately sterilized Class II Meta C.G.M. Spa
Apr 26, 2021 REF 4049 MICROSS, CE0123, STERILE EO. Used in oral surgery. Sterility issues; single use devices labeled as sterile may not have been adequately sterilized Class II Meta C.G.M. Spa
Apr 23, 2021 Sapi Med sterile disposable colorectal anoscopes and proctoscopes. REF/Pro... Due to issue with product sterility. Sterilization service provider had falsified records. Class II Adler MicroMed, Inc.
Apr 21, 2021 Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the f... Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequatel... Class II INNOVATIVE TOMOGRAPHY PRODUCT GMBH
Apr 21, 2021 Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the f... Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequatel... Class II INNOVATIVE TOMOGRAPHY PRODUCT GMBH
Apr 21, 2021 Semi-automatic Biopsy-Needle, ITP innotom.com, CE 0297, STERILE EO for the fo... Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequatel... Class II INNOVATIVE TOMOGRAPHY PRODUCT GMBH
Mar 23, 2021 Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For ... Potential for the pouch to contain an extra laminate layer, creating the potential for the device... Class II Covidien Llc
Feb 23, 2021 Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended ... Evidence of face masks or other material in the seal in several kits, causing improper seals and ... Class II Trinity Sterile, Inc.
Feb 22, 2021 Smart Port CT-Implantable Port Catalogue #: CT96STSD-VI, CT96STSA-VI - Produc... AngioDynamics, Inc. is recalling a specific batch of AngioDynamics Implantable Infusion Port kits... Class II Angiodynamics Inc. (Navilyst 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.