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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
Feb 9, 2021 Magellan Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x 1.6 cm). A single ... Safety shield not locking into the cannula. If the safety shield activation fails to lock a conta... Class II Cardinal Health 200, LLC
Feb 9, 2021 Magellan 3 mL Syringe with Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x ... Safety shield not locking into the cannula. If the safety shield activation fails to lock a conta... Class II Cardinal Health 200, LLC
Feb 9, 2021 McKesson PREVENT M NEEDLE (Magellan Technology) 25G X 5/8". A single lumen ... Safety shield not locking into the cannula. If the safety shield activation fails to lock a conta... Class II Cardinal Health 200, LLC
Feb 8, 2021 Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2 Potential false positive HSV results. Siemens Healthcare Diagnostics, Inc. initiated a correctio... Class II Siemens Healthcare Diagnostics, Inc
Feb 3, 2021 Coronavirus antigen detection test system - Product Usage: intended for the q... Two lots of test strips failed QC testing using blank buffer due to false positives. Class II LumiraDx
Feb 2, 2021 IntelliVue MX40 Patient Monitor, Model Number: 865350 (US) 865352 (OUS) Softw... Manufacturing failed to follow process steps resulting in the distribution of potentially defecti... Class II Philips North America Llc
Feb 1, 2021 Omnipod DASH Insulin Management System User Guide (OUS Only) Product Catalo... Certain foreign user guides include a misprint which could lead to an incorrect bolus delivery an... Class II Insulet Corporation
Jan 19, 2021 Captivator II Single-Use Polypectomy Snares Outer box UPN, Inner Pouch UP... Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a pa... Class II Boston Scientific Corporation
Jan 19, 2021 Captivator/Captiflex/Sensation Short Throw Single-Use Polypectomy Snares O... Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a pa... Class II Boston Scientific Corporation
Jan 19, 2021 Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Sn... Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a pa... Class II Boston Scientific Corporation
Jan 15, 2021 Medtronic 6F Launcher Guide Catheter 100 cmJL 3.5 Model Number: LA6JL35 Sterility may be compromised due to an unsealed pouch Class II Medtronic Vascular
Jan 15, 2021 Medtronic 6F Launcher Guide Catheter 100 cm JR 4.0 Model Number: LA6JR40 Sterility may be compromised due to an unsealed pouch Class II Medtronic Vascular
Jan 15, 2021 Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75 Model Number: LA6EBU375 Sterility may be compromised due to an unsealed pouch Class II Medtronic Vascular
Jan 15, 2021 Medtronic 6F Launcher Guide Catheter 100 cm EBU 3.0 Model Number: LA6EBU30 Sterility may be compromised due to an unsealed pouch Class II Medtronic Vascular
Jan 13, 2021 Covidien Parietex hydrophilic anatomical mesh 15 cm x 10 cm polyester left - ... incorrect device is contained in the package. The packaging label indicates that the device is fo... Class II Covidien Llc
Jan 12, 2021 Grasper/Retriever, Alligator Jaw 2.4 mm x 5 mm x 230 cm Catalog Number: 7208 ... Mislabeled: Devices labeled as catalog #7208 (Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 2... Class II Shent USA, Inc.
Jan 12, 2021 Grasper/Retriever, Alligator Jaw, Rat Tooth 2.4 mm x 8 mm x 230 cm Catalog ... Mislabeled: Devices labeled as catalog #7208 (Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 2... Class II Shent USA, Inc.
Jan 11, 2021 LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Sever... Observations of potential false positive results in the specified lots. Use of these test strips ... Class II LumiraDx
Dec 24, 2020 PHILIPS Incisive Computed tomography X-ray system Incisive CT Software Upgra... Patient tabletop moved out to the home position during scan initialization, may cause operator/by... Class II Philips North America
Dec 23, 2020 Infinity Acute Care System (IACS) Monitoring Solution: The IACS is intended ... The Infinity M540 patient monitor may randomly reboot due to an error to correctly transmit and r... Class II Draegar Medical Systems, Inc.
Dec 22, 2020 Wako HDL-C/LDL-C Calibrator - Product Usage: designed to be used with Wako L-... FUJIFILM has become aware that incorrect concentration values were printed on the bottle label fo... Class III Fujifilm Medical Systems U.S.A., Inc.
Dec 21, 2020 SERF Novae Dual Mobility Cup Insert 47/28- ApeX-LNK Poly Liner. Intended for ... Acetabular Liners have a higher than acceptable oxidation limit, potential for patients to experi... Class II OMNIlife science Inc.
Dec 21, 2020 SERF Novae Dual Mobility Cup Insert 51/28- ApeX-LNK Poly Liner. Intended for ... Acetabular Liners have a higher than acceptable oxidation limit, potential for patients to experi... Class II OMNIlife science Inc.
Dec 21, 2020 SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner. Intended for u... Acetabular Liners have a higher than acceptable oxidation limit, potential for patients to experi... Class II OMNIlife science Inc.
Dec 17, 2020 Fresenius Medical Care NaturaLyte Liquid Acid concentrate-Liquid Acid Concent... Bottles Missing Product Label Class II Fresenius Medical Care Holdings, Inc.
Dec 11, 2020 FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Usage: in... The software does not update measurements and calculations in the Clinical Reporting Application ... Class II Fujifilm Medical Systems U.S.A., Inc.
Dec 8, 2020 ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system After the user selects the Lock-in command, the kV and mA values are not locked immediately and c... Class II PHILIPS HOME HEALTHCARE SOLUTION
Dec 1, 2020 AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm UPN: M00... The rotating luer fitting at the distal end of the delivery system handle may become detached fr... Class II Boston Scientific Corporation
Dec 1, 2020 Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm (OUS... The rotating luer fitting at the distal end of the delivery system handle may become detached fr... Class II Boston Scientific Corporation
Dec 1, 2020 AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm UPN: M00... The rotating luer fitting at the distal end of the delivery system handle may become detached fr... Class II Boston Scientific Corporation
Dec 1, 2020 Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm (OUS... The rotating luer fitting at the distal end of the delivery system handle may become detached fr... Class II Boston Scientific Corporation
Dec 1, 2020 AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm UPN: M00... The rotating luer fitting at the distal end of the delivery system handle may become detached fr... Class II Boston Scientific Corporation
Dec 1, 2020 Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm (OUS... The rotating luer fitting at the distal end of the delivery system handle may become detached fr... Class II Boston Scientific Corporation
Nov 23, 2020 Naturalyte Liquid Acid concentrate bottles, Product Code 08-2301-3 - Product ... The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity... Class II Fresenius Medical Care Holdings, Inc.
Nov 23, 2020 Naturalyte Liquid Acid concentrate drums, Product Code 13-3251-9 - Product Us... The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity... Class II Fresenius Medical Care Holdings, Inc.
Nov 23, 2020 Naturalyte Liquid Acid concentrate bottles, Product Code 08-1251-1 - Product ... The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity... Class II Fresenius Medical Care Holdings, Inc.
Nov 23, 2020 Naturalyte Liquid Acid concentrate bottles, Product Code 08-3251-9 - Product ... The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity... Class II Fresenius Medical Care Holdings, Inc.
Nov 23, 2020 Citrasate Liquid Acid concentrate drums, Product Code 13-2251 -CA - Product U... The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity... Class II Fresenius Medical Care Holdings, Inc.
Nov 23, 2020 Naturalyte Liquid Acid concentrate bottles, Product Code 08-2251-0 - Product ... The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity... Class II Fresenius Medical Care Holdings, Inc.
Nov 23, 2020 Covidien TA Auto Suture Vascular Stapler with DST Series Technology 30mm-V 3... May contain a damaged internal component which could impede staple deployment and result in incom... Class II Covidien Llc
Nov 23, 2020 Naturalyte Liquid Acid concentrate drums, Product Code 13-2251-0 - Product Us... The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity... Class II Fresenius Medical Care Holdings, Inc.
Nov 23, 2020 Citrasate Liquid Acid concentrate bottles, Product Code 08-2251-CA - Product ... The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity... Class II Fresenius Medical Care Holdings, Inc.
Nov 23, 2020 Naturalyte Liquid Acid concentrate bottles, Product Code 08-4231-0 - Product ... The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity... Class II Fresenius Medical Care Holdings, Inc.
Nov 23, 2020 Covidien TA Auto Suture Vascular Loading Unit with DST Series Technology 30 m... May contain a damaged internal component which could impede staple deployment and result in incom... Class II Covidien Llc
Nov 23, 2020 Naturalyte Liquid Acid concentrate bottles, Product Code 08-2351-8 - Product ... The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity... Class II Fresenius Medical Care Holdings, Inc.
Nov 23, 2020 Naturalyte Liquid Acid concentrate bottles, Product Code 08-2201-5 - Product ... The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity... Class II Fresenius Medical Care Holdings, Inc.
Nov 19, 2020 Emission Computed Tomography System Image Process System - Product Usage: int... A software defect that has the potential to result in image misdiagnosis and incorrect treatment ... Class II Philips North America, LLC
Nov 18, 2020 Philips IntelliVue X2 Multi measurement Server: M3002A (865039) - Product Usa... Speakers on IntelliVue X2 and IntelliVue MP2 may fail, identified by the display of a Speaker M... Class II Philips North America Llc
Nov 18, 2020 Philips IntelliVue MP2 Patient Monitors (865040) - Product Usage: intended fo... Speakers on IntelliVue X2 and IntelliVue MP2 may fail, identified by the display of a Speaker M... Class II Philips North America Llc
Nov 16, 2020 Contour VL Variable Length Ureteral Stent, UPN M0061801550, M0061801560, M006... Trace amounts of metallic debris were found on the stent related to the manufacturing process. Th... Class II Boston Scientific 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.