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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

Infrastructure

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

3,419 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,419 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 3,419 FDA device recalls in MA.

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DateProductReasonClassFirm
Feb 4, 2014 Optiflux F160NRe High Flux Dialyzers; Product Number: 0500316E. Single Use... Dialysate Port Leak During Priming of the Dialyzers Class II Fresenius Medical Care Holdings, Inc.
Feb 4, 2014 Optiflux F200NRe High Flux Dialyzers; Product Number: 0500320E. Single Use... Dialysate Port Leak During Priming of the Dialyzers Class II Fresenius Medical Care Holdings, Inc.
Feb 4, 2014 Optiflux F200NR High Flux Dialyzers; Product Number: 0500320N. Single Use ... Dialysate Port Leak During Priming of the Dialyzers Class II Fresenius Medical Care Holdings, Inc.
Jan 24, 2014 NovaSure Impedance Controlled Endometrial Ablation System Radiofrequency Cont... NovaSure Radiofrequency Control Units may not meet a requirement of the electrical standard, IEC ... Class II Hologic, Inc
Jan 24, 2014 NxStage PureFlow-B Solution; Model/Catalog Number: RFP-401. Product is packa... Mislabeled product. Class II NxStage Medical, Inc.
Jan 24, 2014 Philips HeartStart XL+ Defibrillator/Monitor Model: 861290 The HeartStart... HeartStart XL+ battery charge time to 100% capacity at 35¿C (95¿F) is slightly longer than the sp... Class II Philips Medical Systems, Inc.
Jan 17, 2014 MEDITECH Microbiology - Calculator/data processing module, for clinical use. Potential for patient results being removed from LAB/EMR. Class II Medical Information Technology, Inc.
Dec 18, 2013 ADVIA Centaur¿ Systems Phenytoin Calibrator N ( PHTN) 6-pack SMN 10314977 ... ADVIA Centaur¿ Systems Phenytoin Calibrator N, lots CN58 and higher, change in recovery observe... Class II Siemens Healthcare Diagnostics, Inc
Dec 18, 2013 ADVIA Centaur¿ Systems Phenytoin Calibrator N ( PHTN) 2-pack SMN 10311391 ... ADVIA Centaur¿ Systems Phenytoin Calibrator N, lots CN58 and higher, change in recovery observe... Class II Siemens Healthcare Diagnostics, Inc
Dec 18, 2013 Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Inject... Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloo... Class II Boston Scientific Corporation
Dec 18, 2013 Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injec... Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloo... Class II Boston Scientific Corporation
Dec 18, 2013 Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 9-12 mm Injects... Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloo... Class II Boston Scientific Corporation
Dec 17, 2013 Fresenius Bicarbonate Jug Adapter to the 2008 Series Hemodialysis machine Pa... Bicarbonate Jug Adapter distributed prior to 510(k) approval Class II Fresenius Medical Care Holdings, Inc.
Dec 13, 2013 CODMAN CERTAS Programmable Valves, central nervous system shunt, models as fo... Ensuring all customers have the tools to assist in verifying the setting of the valve on x-ray im... Class II Codman & Shurtleff, Inc.
Dec 11, 2013 AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the identificat... Kits incompatible with certain fluorescence microscope light sources Class III AdvanDx, Inc.
Dec 10, 2013 Philips HeartStart MRx Monitor/Defibrillator with CO2/EtCO2 Measurement T... MRx defibrillator displays a -?- for EtCO2 and does not display EtCO2 values when patient CO2 lev... Class II Philips Medical Systems, Inc.
Dec 5, 2013 Philips Essenta DR, a Stationary x-ray system, X-ray system Model: 712070 ... X-ray system C-arm casting may loosen and fall Class II Philips Medical Systems, Inc.
Nov 25, 2013 Port Kit with Access Infusion Set under the following labels: 1) 8F/SL/Plasti... Navilyst Medical has recalled a Port Kit with Access Infusion Set due to a possible breach of ste... Class II Navilyst Medical, Inc.
Nov 20, 2013 TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 5 configuration) Univ... Sterility of device may be compromised due to lack of pouch seal integrity Class II Boston Scientific Corporation
Nov 20, 2013 Indus Invue Screws: IM71058-XX: 04.2mm, SelfTapping, Tapered. Used to sec... Mismarked and unmarked screws Class II SpineFrontier, Inc.
Nov 20, 2013 Indus Invue Screws: IM71016-XX: 04.5mm, SelfTapping. Used to secure the In... Mismarked and unmarked screws Class II SpineFrontier, Inc.
Nov 20, 2013 PedFuse Reset Screw Inserters; PedFuse Screw Inserter 08-9 REset Part# 11-801... Screw inserters may not mate properly with hex interface of the screws. Class II SpineFrontier, Inc.
Nov 20, 2013 PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REset Part #11-801... Screw inserters may not mate properly with hex interface of the screws. Class II SpineFrontier, Inc.
Nov 20, 2013 TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 10 configuration) Unive... Sterility of device may be compromised due to lack of pouch seal integrity Class II Boston Scientific Corporation
Nov 20, 2013 TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 1 configuration) Univ... Sterility of device may be compromised due to lack of pouch seal integrity Class II Boston Scientific Corporation
Nov 20, 2013 Indus Invue Screws: lM71059-XX: Indus Screw 04.2mm SelfDrilling. Used to s... Mismarked and unmarked screws Class II SpineFrontier, Inc.
Nov 20, 2013 Indus Invue Screws: IM71013-XX: Indus Screw04.0mm SelfDrilling. Used to se... Mismarked and unmarked screws Class II SpineFrontier, Inc.
Nov 20, 2013 TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 5 configuration) Unive... Sterility of device may be compromised due to lack of pouch seal integrity Class II Boston Scientific Corporation
Nov 20, 2013 TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 10 configuration) Inte... Sterility of device may be compromised due to lack of pouch seal integrity Class II Boston Scientific Corporation
Nov 20, 2013 PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REspond Part# 11-8... Screw inserters may not mate properly with hex interface of the screws. Class II SpineFrontier, Inc.
Nov 20, 2013 TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 1 configuration) Univ... Sterility of device may be compromised due to lack of pouch seal integrity Class II Boston Scientific Corporation
Nov 15, 2013 HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220 HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval Class II Instrumentation Laboratory Co.
Nov 15, 2013 HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120 HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval Class II Instrumentation Laboratory Co.
Nov 15, 2013 HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320 HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval Class II Instrumentation Laboratory Co.
Nov 13, 2013 Intubation Flexible Fiberscope, Models: 11301AA1, 11301BN1, 11302BD1, 11302BD... KARL STORZ Endoscopy America, Inc. is recalling the Flexible Broncho Fiberscope or a Flexible Int... Class II Karl Storz Endoscopy America Inc
Nov 13, 2013 Broncho Flexible Fiberscope, models: 11001BN1, 11002BD1, 11004BC1, and 11009B... KARL STORZ Endoscopy America, Inc. is recalling the Flexible Broncho Fiberscope or a Flexible Int... Class II Karl Storz Endoscopy America Inc
Nov 12, 2013 Fresenius 2008 Series Hemodialysis Machines: Models: 2008H, 2008K, 2008K2, 2... 2008 Series Hemodialysis Machines complaints of saline bags inappropriately filling during recirc... Class II Fresenius Medical Care Holdings, Inc.
Nov 6, 2013 Candela Laser GentleLase Pro, Powered Laser Surgical Instrument for dermatolo... Unintended single pulse maybe emitted to handpiece prior to pressing of trigger or footswitch an... Class II Candela Corporation
Nov 6, 2013 Axillent Debakey Grasping Forceps, Part No. 33821DYD In general the surgeo... KARL STORZ is recalling the Axillent Debakey Grasping Forceps because the 33821WTD Wavy grasper w... Class II Karl Storz Endoscopy America Inc
Nov 5, 2013 Navigator HD l3F/15F x 28 cm Ureteral Access Sheath Set Product No M00625022... The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports ... Class II Boston Scientific Corporation
Nov 5, 2013 Navigator HD l3F/15F x 36cm Ureteral Access Sheath Set Product No M006250228... The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports ... Class II Boston Scientific Corporation
Nov 5, 2013 Navigator HD l3F/15F x 46cm Ureteral Access Sheath Set Product No M006250228... The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports ... Class II Boston Scientific Corporation
Oct 30, 2013 Easy Diagnost Eleva Universal Fluoroscopic applications The delivered application software was an outdated version to the model of equipment. Class II Philips Medical Systems, Inc.
Oct 23, 2013 BrightView XCT is a gamma camera for Single Photon Emission Computed Tomograp... It was discovered the CT portion of the scan was interrupted ( stopping the CT exposure at the ti... Class II Philips Medical Systems, Inc.
Oct 21, 2013 Cougar¿ Nitinol Workhorse Guidewire: Models: CGRLS190HJ, CGRLS190HS, CGRLS19... Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. Class I Medtronic Vascular
Oct 21, 2013 Zinger¿ Stainless Steel Workhorse Guidewire; Models: ZNGRLS180HJ, ZNGRLS180HS... Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. Class I Medtronic Vascular
Oct 21, 2013 THUNDER¿ Extra Support Guidewire; Models: THNDR190J, THNDR190S, THNDR300J, T... Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. Class I Medtronic Vascular
Oct 21, 2013 ATTAIN HYBRID¿ Guide Wire; Models: GWR419478, GWR419488, GWR419688 The Att... Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. Class I Medtronic Vascular
Oct 21, 2013 ZINGER¿ Steerable Guidewire; Models: LVZRLS180J, LVZRLS180S, LVZRMS180J, LVZR... Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. Class I Medtronic Vascular
Oct 21, 2013 ProVia¿ CROSSING GUIDEWIRE; Models: 15PROV300HS, 3PROV180HS, 3PROV180SS, 3PR... Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. Med... Class I Medtronic Vascular

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.