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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

3,505 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,505 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 3,505 FDA device recalls in MA.

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DateProductReasonClassFirm
Jun 21, 2013 LeGoo Internal Vessel Occluder 5mL Product Number: 10-0500 LeGoo is a wat... Product contains particulates (fibers) Class II Genzyme Corporation, A Sanofi Company
Jun 21, 2013 LeGoo¿ Endovascular Occlusion Gel-1.0 mL LeGoo with 3 Cannula Pouch Produc... Product contains particulates (fibers) Class II Genzyme Corporation, A Sanofi Company
Jun 21, 2013 LeGoo Internal Vessel Occluder 10mL Product Number: 10-1000 LeGoo is a wa... Product contains particulates (fibers) Class II Genzyme Corporation, A Sanofi Company
Jun 21, 2013 LeGoo Internal Vessel Occluder 2.5mL Product Number: 10-0250 LeGoo is a w... Product contains particulates (fibers) Class II Genzyme Corporation, A Sanofi Company
Jun 21, 2013 LeGoo Internal Vessel Occluder .25mL Product Number: 10-0025 LeGoo is ... Product contains particulates (fibers) Class II Genzyme Corporation, A Sanofi Company
Jun 21, 2013 LeGoo¿ Endovascular Occlusion Gel-0.5 mL LeGoo w/ no Cannula Product Numbe... Product contains particulates (fibers) Class II Genzyme Corporation, A Sanofi Company
Jun 20, 2013 TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurp... Research Use Only (RUO) parameters were included in TEG 5000 User Manual. Class II Haemonetics Corporation
Jun 19, 2013 Philips HeartStart MRx Monitor/Defibrillator, Model numbers M3535A, M3536A,... The MRx may deliver a non-synchronized cardioversion shock resulting in the delivery of incorrect... Class II Philips Healthcare Inc.
Jun 17, 2013 AlboGraft Knitted with Collagen, Bifurcate 14x08 Catalog Number: AMC1408 ... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Knitted with Collagen, Straight 15x06 Catalog Number: AMC1506 ... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Woven with Collagen, Straight 30x24 Catalog Number: ATC3024 Alb... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Woven with Collagen, Straight 30x16 Catalog Number: ATC3016 Alb... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Knitted with Collagen, Straight 60x07 Catalog Number: AMC6007 A... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Knitted with Collagen, Bifurcate 18x10 Catalog Number: AMC1810 ... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Knitted with Collagen, Bifurcate 18x09 Catalog Number: AMC1809 ... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Woven with Collagen, Straight 30x26 Catalog Number: ATC3026 Alb... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Woven with Collagen, Straight 15x26 Catalog Number: ATC1526 Alb... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Knitted with Collagen, Bifurcate 20x10Catalog Number: AMC2010 ... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Knitted with Collagen, Straight 60x06 Catalog Number: AMC6006 A... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Knitted with Collagen, Straight 40x07 Catalog Number: AMC4007 A... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Woven with Collagen, Straight 30x18 Catalog Number: ATC3018 Alb... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Woven with Collagen, Straight 15x30 Catalog Number: ATC1530 AlboG... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Knitted with Collagen, Straight 60x08 Catalog Number: AMC6008 A... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Knitted with Collagen, Straight 40x08 Catalog Number: AMC4008 A... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 Albo Graft Knitted with Collagen, Bifurcate 16x08 Catalog Number: AMC1608 ... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 11, 2013 Philips Healthcare MobileDiagnostwDR system. Mobile Digital radiography X-Ra... The Instructions for Use (IFU) for the MobileDiagnost wDR fails to comply with a Federal standard... Class II Philips Healthcare Inc.
Jun 7, 2013 MedStream Programmable Infusion Pump , Implantable for the intrathecal delive... Miscalibrated Fill Level Sensor may affect dosing level Class I Codman & Shurtleff, Inc.
Jun 7, 2013 Philips HeartStart MRx Monitor/Defibrillator Models: M3536A Options A20 - A2... Error in the printing of the therapy energy setting labels on Philips HeartStart M3536A MRx Monit... Class II Philips Medical Systems, Inc.
Jun 7, 2013 MedStream Programmable Infusion Pump- Implantable for the intrathecal deliver... Miscalibrated Fill Level Sensor may affect dosing level Class I Codman & Shurtleff, Inc.
Jun 3, 2013 Fresenius Liberty Cycler Set Single Conn./Ext DL Product Number: 050-87216 ... Cassette may leak during set up or during peritoneal dialysis treatment Class II Fresenius Medical Care Holdings, Inc.
May 31, 2013 27023WU Balloon Catheter, 3 Fr., 2/pkg, sterile, contains latex. The RUS... Karl Storz Endoscopy-America has initiated the recall of the 27023WU Balloon Catheter because the... Class II Karl Storz Endoscopy America Inc
May 28, 2013 NephroMax high Pressure Nephrostomy Balloon Catheter. Material Number/Catalog... Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Ca... Class II Boston Scientific Corporation
May 28, 2013 Alair Bronchial Thermoplasty Catheter, Bronchial Thermoplasty System; Materia... Boston Scientific has discovered an inconsistent "Use By" expiration date on a single lot/batch o... Class II Boston Scientific Corporation
May 28, 2013 NephroMax high Pressure nephrostomy Balloon Catheter Kit. Material Number/Ca... Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Ca... Class II Boston Scientific Corporation
May 28, 2013 RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00... Product labeled with incorrect expiration date. Class III Boston Scientific Corporation
May 24, 2013 S-LIFT Inserter Outer Sleeve Product Usage: The Inserter Sleeve is an op... The outer sleeve would not fit over the S-LIFT Inserter assembly because the hole at the top of t... Class II SpineFrontier, Inc.
May 24, 2013 Fresenius Service Replacement 0-Ring. Used in as a service part in 4 sub... Incorrect rubber nitrile O-rings distributed instead of the correct material EPDM. (Ethylene Pro... Class II Fresenius Medical Care Holdings, Inc.
May 24, 2013 GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 13071... lack of sterility assurance Class II Gyrus Acmi, Incorporated
May 17, 2013 BASE, S-LIFT Instrument Case Product Usage: System cases are designed to... The S-LIFT Instrument Case contained a bracket with peeling nylon coating. Class II SpineFrontier, Inc.
May 16, 2013 Codman Certas Programmable Valve In Line Valve Only Product Code: 82-8800 ... Codman Certas Programmable Valves used for hydrocephalus may not operate properly Class II Codman & Shurtleff, Inc.
May 16, 2013 Codman Certas Programmable Valve In Line Valve with Catheter and Accessories ... Codman Certas Programmable Valves used for hydrocephalus may not operate properly Class II Codman & Shurtleff, Inc.
May 16, 2013 Codman Certas Programmable Valve In Line Valve only with SiphonGuard Device ... Codman Certas Programmable Valves used for hydrocephalus may not operate properly Class II Codman & Shurtleff, Inc.
May 16, 2013 Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Cathe... Codman Certas Programmable Valves used for hydrocephalus may not operate properly Class II Codman & Shurtleff, Inc.
May 16, 2013 Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Uniti... Codman Certas Programmable Valves used for hydrocephalus may not operate properly Class II Codman & Shurtleff, Inc.
May 16, 2013 Codman Certas Programmable Valve In Line Valve with Siphonguard, Unitized Cat... Codman Certas Programmable Valves used for hydrocephalus may not operate properly Class II Codman & Shurtleff, Inc.
May 16, 2013 Codman Certas Programmable Valve In Line Valve with Unitized BactiSeal Cathet... Codman Certas Programmable Valves used for hydrocephalus may not operate properly Class II Codman & Shurtleff, Inc.
May 14, 2013 ADVIA Centaur¿ iPTH ReadyPack Assay 100 Tests; REF 10492368. For in vitro ... iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability Class II Siemens Healthcare Diagnostics, Inc
May 14, 2013 ADVIA Centaur iPTH Calibrator 2 pk; REF 10492394. For in vitro diagnostic ... iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability Class II Siemens Healthcare Diagnostics, Inc
May 14, 2013 ADVIA Centaur¿ iPTH ReadyPack Assay 500 Tests; REF 10492369, 10493615, 104936... iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability Class II Siemens Healthcare Diagnostics, Inc
May 14, 2013 ADVIA Centaur¿ iPTH Calibrator 6 pk; REF: 10492387, 10630628. For in vitr... iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability Class II Siemens Healthcare Diagnostics, 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.