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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

3,419 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
Apr 6, 2020 Philips Brilliance iCT Computed Tomography X-Ray System; Model # 728306; UDI ... The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips... Class II Philips North America, LLC
Apr 6, 2020 Philips Brilliance iCT SP Computed Tomography X-Ray System; Model # 728311 The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips... Class II Philips North America, LLC
Apr 3, 2020 Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1... When a user acquires XperCT scan on an Azurion 2.0 system, enters the XperGuide guidance step and... Class II Philips North America, LLC
Apr 2, 2020 Omnipod DASH Insulin Management System (mmol/L configuration), Catalog Numbe... After the device has been in use for about 2 months, data processing in the PDM can be slowed suc... Class II Insulet Corporation
Apr 2, 2020 Omnipod DASH Insulin Management System (mg/dL configuration), Catalog Number ... After the device has been in use for about 2 months, data processing in the PDM can be slowed suc... Class II Insulet Corporation
Mar 30, 2020 MoXy Laser Fiber, Material Number 0010-2400 - Product Usage: The fiber can be... To reinforce existing instructions within the Directions for Use (DFU) and provide further guidan... Class II Boston Scientific Corporation
Mar 23, 2020 LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e165... There has been an increased trend in reports of catheters failing to deflate during use, which ma... Class I LeMaitre Vascular, Inc.
Mar 17, 2020 Smith & Nephew FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5 Part Number: 72202901 Space between the device and the packaging permits excessive movement which could potentially lea... Class II Smith & Nephew, Inc.
Mar 17, 2020 Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, 5.5mm Part Number: 72202902 Space between the device and the packaging permits excessive movement which could potentially lea... Class II Smith & Nephew, Inc.
Mar 12, 2020 Fresenius 2008T BlueStar Hemodialysis Machine Part Number Description: 19... A "Remove USB Device 2" false alarm may be displayed when no USB device or a non-powered USB devi... Class II Fresenius Medical Care Holdings, Inc.
Mar 12, 2020 Fresenius 2008T Hemodialysis Machine: Part Number Description 190573 2008T ... A "Remove USB Device 2" false alarm may be displayed when no USB device or a non-powered USB devi... Class II Fresenius Medical Care Holdings, Inc.
Mar 9, 2020 Percuflex Plus Ureteral Stent Set 7FX24CM with .035 Sensor UPN: M00617527208... An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... Class II Boston Scientific
Mar 9, 2020 Percuflex Plus Ureteral Stent Set 6FX24CM with .038 Sensor UPN: M00617526... An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... Class II Boston Scientific
Mar 9, 2020 Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX STR/150CM UPN: M00667... An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... Class II Boston Scientific
Mar 9, 2020 Stretch VL Ureteral Stent Set 7FX22-30CM with .035 Sensor UPN: M006185157080 An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... Class II Boston Scientific
Mar 9, 2020 Stretch VL Ureteral Stent Set 4.8FX22-30CM with .035 Sensor UPN: M006185155080 An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... Class II Boston Scientific
Mar 9, 2020 Contour VL Ureteral Stent Set 6FX22-30CM with .035 Sensor UPN: M006180156080 An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... Class II Boston Scientific
Mar 9, 2020 Sensor Nitinol Wire with Hydrophilic Tip .038 3CM FLEX STR/150CM UPN: M00... An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... Class II Boston Scientific
Mar 9, 2020 Stretch VL Ureteral Stent Set 6FX22- 30CM with .035 Sensor UPN: M006185156080 An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... Class II Boston Scientific
Mar 9, 2020 Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX /150CM UPN: M00667030... An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... Class II Boston Scientific
Mar 9, 2020 Sensor Nitinol Wire with Hydrophilic Tip .0383CM FLEX ANG/150CM UPN: M006... An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... Class II Boston Scientific
Mar 9, 2020 Polaris Ultra Ureteral Stent Set 6FX24CM with .035 Sensor UPN: M006192132080 An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... Class II Boston Scientific
Mar 9, 2020 Percuflex Plus Ureteral Stent Set 6FX26CM with .038 Sensor UPN: M006175263110 An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... Class II Boston Scientific
Mar 5, 2020 Phillips Azurion 7 M20, Angiographic X-Ray System Code 722079 Image guidan... No torque was specified for the four screws that connect the gearbox and the mounting flange with... Class II Philips North America, LLC
Mar 5, 2020 TRx4851A 2.4 GHz IntelliVue Tele TRX, Model Number 862231; Includes Service N... The ECG signal from patients being monitored using a Philips TRx4841A and TRx4851A Telemetry Tran... Class II Philips North America, LLC
Mar 5, 2020 TRx4841A 1.4 GHz IntelliVue Tele TRX, Model Number 862439; Includes System ... The ECG signal from patients being monitored using a Philips TRx4841A and TRx4851A Telemetry Tran... Class II Philips North America, LLC
Feb 26, 2020 HeartStart MRx Monitor/Defibrillators with model numbers M3535A M3536A, M353... Philips has received a number of reports of HeartStart MRx Monitor/Defibrillators that have suffe... Class II Philips North America, LLC
Feb 20, 2020 Expression MR400 MRI Patient Monitoring System Model Number: 866185 Softwa... Menu selections for users to access the oxygen (O2) sensor calibration were changed and not incor... Class II Philips North America, LLC
Feb 19, 2020 TEG Manager software versions used in conjunction with TEG 5000 are 1.1.0, 3.... Software defect in TEG Manager impacts the displayed alert for out of range test results. Due to ... Class II Haemonetics Corporation
Feb 13, 2020 Omnipod DASH Personal Diabetes Manager (PDM), Catalog numbers US: 18239 M/D... In certain scenarios, the Omnipod DASH PDM may suggest an inaccurate bolus amount based on a blo... Class II Insulet Corporation
Feb 10, 2020 Covidien Force TriVerse Electrosurgical Devices, Product numbers FT3000 and F... Sterile packaging may potentially be compromised, and use of products may result in increased ris... Class II Covidien Llc
Feb 10, 2020 Kits containing Covidien Force TriVerse Electrosurgical Devices. Distributed ... Sterile packaging may potentially be compromised, and use of products may result in increased ris... Class II Covidien Llc
Feb 3, 2020 iTotal CR Knee Replacement System, Model No. TCR-121-1111-010102, (ITOTAL CR ... A limited number of tibial trays were labeled with an incorrect serial number and were delivered ... Class II Conformis, Inc.
Feb 3, 2020 iTotal PS Knee Replacement System, Model No. TPS-111-1111-010101, (ITOTAL PS ... A limited number of tibial trays were labeled with an incorrect serial number and were delivered ... Class II Conformis, Inc.
Jan 29, 2020 Honeywell Pressure Transducer- Part Number: 370506-22. It is a component used... The firm is replacing pressure transducers with an improved design due to an increase in customer... Class II Fresenius Medical Care Holdings, Inc.
Jan 28, 2020 Protective Cover Vivo 55/65 (Used for Vivo 50/65), Part No. 006344. It is an ... The outlet hole of the exhalation valve control pressure tube on the ventilator may become obstru... Class II Breas Medical, Inc.
Jan 17, 2020 Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, trans... Potential for the sterile barrier to be compromised. Products with a compromised sterile barrier ... Class II COVIDIEN LLC
Jan 15, 2020 Monoject Bluntfill with Filter, 18G x 1-1/2" Item Code 11811022F. Used for d... Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "... Class II Cardinal Health 200, LLC
Jan 15, 2020 Monoject Hypodermic Safety Needle 25G x 5/8" Item Code 1182558 - Product Usa... Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "... Class II Cardinal Health 200, LLC
Jan 15, 2020 Monoject 3mL Syringe with Hypodermic Safety Needle, 22G x 1-1/2 . Item Code 1... Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "... Class II Cardinal Health 200, LLC
Jan 15, 2020 Monoject Hypodermic Safety Needle 30G X 1/2" Item Code 1183005 - Product Usag... Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "... Class II Cardinal Health 200, LLC
Jan 14, 2020 Ambulance Parameter Extension (APE) kit M4758A, an accessory to the Philips H... M4758A Ambulance Parameter Extension (APE) kit may cause ECG "Leads Off" condition in hot, humid ... Class II Philips North America, LLC
Jan 13, 2020 Philips DigiTrak XT Holter Recorder Software version number B.1 and C.2. Th... if an AAA battery is inserted in the recorder and a user attempts to start it, or if the recorde... Class II Philips North America, LLC
Dec 30, 2019 Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 ... A capacitor inside the converter of the Velara X-ray generator may fail after a large number of s... Class II Philips North America, LLC
Dec 30, 2019 Allura CV20, system code 722031 A capacitor inside the converter of the Velara X-ray generator may fail after a large number of s... Class II Philips North America, LLC
Dec 30, 2019 Poly G Integris H5000, System code 72246 A capacitor inside the converter of the Velara X-ray generator may fail after a large number of s... Class II Philips North America, LLC
Dec 30, 2019 MultiDiagnost Eleva, System codes 722030 722016 722017 708032 708036 708... A capacitor inside the converter of the Velara X-ray generator may fail after a large number of s... Class II Philips North America, LLC
Dec 30, 2019 TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intende... Due to a potential for sterile barrier breach. A complaint was received that indicated the protec... Class II Smith & Nephew, Inc.
Dec 30, 2019 Integris Allura 15 & 12, monoplane (system code 722043) and biplane (system c... A capacitor inside the converter of the Velara X-ray generator may fail after a large number of s... Class II Philips North America, LLC
Dec 30, 2019 OmniDiagnost Eleva System codes 708028 708027 A capacitor inside the converter of the Velara X-ray generator may fail after a large number of s... Class II Philips North America, LLC

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.