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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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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
Aug 24, 2015 Terumo Custom Cardiovascular Procedure Kit X-Coated Pediatric Pack P/N: 74... Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performanc... Class II Terumo Cardiovascular Systems Corp
Aug 24, 2015 Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack with FX25R... Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performanc... Class II Terumo Cardiovascular Systems Corp
Aug 24, 2015 Terumo Custom Cardiovascular Procedure Kit Tubing Pack P/N: 66041-1 Terumo ... Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performanc... Class II Terumo Cardiovascular Systems Corp
Aug 24, 2015 Siemens RAPIDPoint 500 Measurement Cartridge Lactate (750 tests) Part Number... RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodiu... Class II Siemens Healthcare Diagnostics Inc
Jul 28, 2015 RAPIDPoint 500 Blood Gas Analyzer, Siemens Material Numbers (SMN):10492730, ... When both ports (Serial and Ethernet) are configured to transmit data, the data stream from one p... Class II Siemens Healthcare Diagnostics Inc
Jul 27, 2015 ADVIA Centaur¿ Folate Ascorbic Acid/Ascorbic Acid Diluent; SMN 10316877. Use... Low red blood cell control recoveries and low results for red blood cell patient samples when usi... Class II Siemens Healthcare Diagnostics, Inc
Jul 23, 2015 Philips GoSafe Mobile Help Button; 7000MHB. Personal Emergency Response Sy... Irregular battery disconnection resulted in issues with Mobile Health Button (MHB) Charging. Class II Lifeline Systems, Incorporated
Jul 22, 2015 Philips Healthcare TraumaDiagnost; Codes: 72001, 720011, 720013, 720020; A ra... If arm is not fastened securely it could fall down. Class II Philips Electronics North America Corporation
Jul 16, 2015 Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle A Dialysate Conce... Expansion of recall to lots manufactured in 2015 due to the potential for bacterial contamination. Class II Fresenius Medical Care Holdings, Inc.
Jul 13, 2015 OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Cat... OmniPods¿ (Pods) have a higher rate of failure causing: Cannula fails to deploy/retract causing ... Class I Insulet Corporation
Jul 13, 2015 OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Ca... OmniPods¿ (Pods) have a higher rate of failure causing: Cannula fails to deploy/retract causing ... Class I Insulet Corporation
Jul 6, 2015 Actuator for angiographic x-ray monitor ceiling suspension system. Actuator ... The actuator assembly became detached and the monitor carriage with a flexvision monitor dropped ... Class II Philips Electronics North America Corporation
Jul 6, 2015 SENSE Body Coil 1.5T with identification; used in the ACS NT, Intera 1.5T an... Wrong positioning of the coil cables can create unintended resonances via the patient or elevated... Class II Philips Electronics North America Corporation
Jun 17, 2015 Invivo Expression MRI Patient Monitoring System. The device's labeling inaccurately indicates Endotracheal as a body temperature application site.... Class II Philips Electronics North America Corporation
Jun 9, 2015 Offset Femoral Alignment Guide, 2mm x 6¿; Product Code: KS 67022 Product U... The markings on both versions of the OFFSET FEMORAL ALIGNMENT GUIDES are incorrect. Specifically,... Class II Omnilife Science Inc.
Jun 9, 2015 Offset Femoral Alignment Guide 4mm x 6¿; Product Code: KS 67024 Product Us... The markings on both versions of the OFFSET FEMORAL ALIGNMENT GUIDES are incorrect. Specifically,... Class II Omnilife Science Inc.
Jun 9, 2015 Olympus Scientific Solutions Americas Analytical X-ray System. Delta, Delta... Higher than published scatter around the probe head when testing some samples. At the point the c... Class II Olympus Scientific Solutions Americas
Jun 5, 2015 Philips HeartStart XL+ Defibrillator/Monitor Product Usage: The HeartStar... Multiple software and hardware issues with device that can affect its function. Class II Philips Electronics North America Corporation
Jun 4, 2015 APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-1... The device may have improper screw hole placement due to inaccurate location of the index line. Class II Omnilife Science Inc.
Jun 3, 2015 WIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470-0050 The Wi... Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results Class II Perkinelmer
Jun 3, 2015 WIZARD2 2-detector, 550 samples Product Code: 2470-0020 The Wizard¿" gamm... Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results Class II Perkinelmer
Jun 3, 2015 Perkin Elmer WIZARD2 10-detector, 1000 samples Product Code: 2470-0200, 3470... Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results Class II Perkinelmer
Jun 3, 2015 Perkin Elmer WIZARD2 1-detector, 550 samples Product Code: 2470-0010 The ... Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results Class II Perkinelmer
Jun 3, 2015 Perkin Elmer WIZARD2 5-detector, 1 000 samples Product Code: 2470-0150, 3470... Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results Class II Perkinelmer
Jun 3, 2015 Perkin Elmer WIZARD2 1-detector,3", 1000 samples Product Code: 2480-0010 ... Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results Class II Perkinelmer
Jun 3, 2015 Apex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA Product Us... Product may breach the inner and outer sterile pouches during shipping or handling. Class II Omnilife Science Inc.
Jun 3, 2015 Perkin Elmer WIZARD2 10-detector, 550 samples Product Code: 2470-0100, 3470-... Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results Class II Perkinelmer
Jun 2, 2015 CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recording System, 120 channels, ... Boston Scientific has received complaints indicating that, when using the blood pressure (BP) cha... Class II Boston Scientific Corporation
May 22, 2015 American Science & Engineering Inc,Gemini Cabinet X-ray system. During factory testing, we discovered that Gemini systems could, in rare circumstances, experienc... Class II American Science & Engineering, Inc.
May 20, 2015 NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for Hemodial... Bacterial contamination. Class II Fresenius Medical Care Holdings, Inc.
May 19, 2015 ADVIA Centaur Tni-Ultra Assay; SMN 10317708 - 100 tests and SMN 10317709 -500... System-to-system bias between the Tni-Ultra assay on the ADVIA Centaur CP and ADVIA Centaur/ADVI... Class II Siemens Healthcare Diagnostics, Inc
May 8, 2015 Gyrus ACMI Diego Elite Tubeset; intended for cutting, coagulation, drilling, ... Potential lack of sterility assurance. Class II Gyrus Acmi, Incorporated
May 8, 2015 Gyrus ACMI Diego Elite Tubeset, intended for cutting, coagulation, drilling, ... Potential lack of sterility assurance. Class II Gyrus Acmi, Incorporated
May 6, 2015 The Rapidlab 1260 system is a blood gas analyzer used for laboratory testing ... D50 and D51 Diagnostic error codes are not functional. Class II Siemens Healthcare Diagnostics, Inc
May 6, 2015 Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use... The Overpressure Safety Valve is not cleared with an indication for use on the arterial side of t... Class II Terumo Cardiovascular Systems Corp
May 6, 2015 The Rapidlab 1265 system is a blood gas analyzer used for laboratory testing ... D50 and D51 diagnostic error codes are not functional. Class II Siemens Healthcare Diagnostics, Inc
May 1, 2015 BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Gl... Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product Class II Beaver-Visitec International Inc.
May 1, 2015 BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Gl... Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product Class II Beaver-Visitec International Inc.
May 1, 2015 BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Gl... Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product Class II Beaver-Visitec International Inc.
May 1, 2015 BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Gl... Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product Class II Beaver-Visitec International Inc.
May 1, 2015 BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Gl... Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product Class II Beaver-Visitec International Inc.
Apr 30, 2015 ULTRA-FAST FIX Knot Pusher Suture Cutters Product Number: 72201537 Intend... Sterility of device maybe compromised Class II Smith & Nephew, Inc.
Apr 28, 2015 VenaSeal, Sapheon Closure System, Model # SP-101, VS-301 and VS-402. For vasc... Possible sterility breach of the outer packaging (pouch) material which may compromise the outsid... Class II Covidien LLC
Apr 27, 2015 Extractor Pro RX Retrieval Balloon Catheter 9-12 mm Above Retrieval Balloon C... One lot of the Extractor" Pro RX Retrieval Balloon Catheter (9-12mm balloon) contains an incorrec... Class II Boston Scientific Corporation
Apr 27, 2015 CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real ... Blood chamber connection leaks during the use of the CRIT-LINE¿ Blood Chamber Class II Fresenius Medical Care Holdings, Inc.
Apr 23, 2015 Pinnacle3 Software Version 10.0, Model 459800200841. Product Usage: The ... A problem (the dose computed in planning mode is calculated incorrectly ) has been detected in th... Class II Philips Medical Systems, Inc.
Apr 22, 2015 Philips GoSafe Communicator 7000L Personal emergency response system. Home communicator Model 7000L may not sense the phone line under certain unusual landline phone c... Class II Lifeline Systems, Incorporated
Apr 21, 2015 EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut... Device does not mate as intended. Class II DePuy Spine, Inc.
Apr 14, 2015 Philips Healthcare Brilliance 64 Computed Tomography X-ray system During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) sc... Class II Philips Electronics North America Corporation
Apr 14, 2015 Philips Healthcare Ingenuity CT Computed Tomography X-ray system During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) sc... Class II Philips Electronics North America 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.