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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

3,550 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,550 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 3,550 FDA device recalls in MA.

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DateProductReasonClassFirm
Jan 9, 2023 ADVIA Centaur Folate 100 test kit-For in vitro diagnostic use in the quantita... Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/Fo... Class II Siemens Healthcare Diagnostics, Inc.
Jan 9, 2023 Atellica IM Folate 700 test kit (REF)-For in vitro diagnostic use in the quan... Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/Fo... Class II Siemens Healthcare Diagnostics, Inc.
Jan 9, 2023 Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitat... Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/Fo... Class II Siemens Healthcare Diagnostics, Inc.
Dec 22, 2022 HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term acce... Label with the incorrect component listed on the inner kit Tyvek header bag Class II Access Vascular, Inc
Dec 22, 2022 ADVIA Centaur XP and ADVIA Centaur XPT Anti-HBe2 (aHBe2) 50T- In vitro diagno... Anti-HBe2 (aHBe2) interference with the Hepatitis B e Antigen (HBeAg) Assay, leads to elevated or... Class II Siemens Healthcare Diagnostics, Inc.
Dec 22, 2022 HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term acc... Product Mislabeled on the outer bag and inner kit Tyvek header bag Class II Access Vascular, Inc
Dec 20, 2022 CustomEyes kits Device packaging may contain open seals, compromising product sterility. Class II Beaver Visitec International, Inc.
Dec 20, 2022 Ultracell Wick with 80cc Collection Bag, 20/box Device packaging may contain open seals, compromising product sterility. Class II Beaver Visitec International, Inc.
Dec 16, 2022 HydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit, Model Number 80001001 Select catheter lots were identified to be labeled with incorrect expiration date, where the cath... Class II Access Vascular, Inc
Dec 16, 2022 HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002 Select catheter lots were identified to be labeled with incorrect expiration date, where the cath... Class II Access Vascular, Inc
Dec 16, 2022 HydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002 Select catheter lots were identified to be labeled with incorrect expiration date, where the cath... Class II Access Vascular, Inc
Dec 12, 2022 epoc Host 2 as follows: Product SMN epoc NXS Host, US 11... pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure Class II Siemens Healthcare Diagnostics Inc
Dec 12, 2022 epoc Host 2 as follows: Product SMN epoc Host 10736387 e... pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure Class II Siemens Healthcare Diagnostics Inc
Dec 7, 2022 MAHURKAR 13.5Fr High Flow Dual Lumen Acute Dialysis Catheter, Sterile, Single... There is a potential leaking condition within the hub of affected devices, due to an inter-lumen ... Class I Covidien LP
Dec 7, 2022 MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomogra... Stryker received one report of an injury to an untrained user that occurred while the untrained u... Class II Mobius Imaging, LLC
Dec 2, 2022 Lamaze Chill Teether, Fluid-Filled Teething Ring, Model No. Y5288L Affected lots of the product are being recalled due to potential microbial growth in the fluid in... Class II Tomy International Inc.
Nov 30, 2022 Beaver EdgeAhead Stiletto/MVR Knife .90mm Straight (20G)-for ocular paracente... Packaging sterile barrier has been compromised. Open seals can lead to a loss of device sterility... Class II Beaver Visitec International, Inc.
Nov 22, 2022 Philips Upgrade to MR 7700 System, Model Number 782130 Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. Class II Philips North America Llc
Nov 22, 2022 Philips Ingenia Elition X MR System, Model Numbers 781358, 782107, 782119, 78... Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. Class II Philips North America Llc
Nov 22, 2022 Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137 Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. Class II Philips North America Llc
Nov 22, 2022 Philips MR 7700 System, Model Number 782120 Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. Class II Philips North America Llc
Nov 22, 2022 Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 78213... Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. Class II Philips North America Llc
Nov 21, 2022 Philips Fetal Spiral Electrode-intended for patients requiring fetal heart ra... Fetal Spiral Electrode (FSE) spiral tip of the FSE breaking off during use and requiring surgical... Class II Philips North America Llc
Nov 18, 2022 MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomogra... Stryker received a report of a battery fire involving an Airo TruCT unit previously subjected to ... Class II Mobius Imaging, LLC
Nov 14, 2022 Omnipod 5 Automated Insulin Delivery System Product catalog numbers: PT-000... The firm has become aware of an issue with the Omnipod 5 Controller where the Controller charging... Class II Insulet Corporation
Nov 14, 2022 iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE Loctite thread locker (epoxy) may not have been applied to the screw that is part of the handle. ... Class II Conformis, Inc.
Nov 8, 2022 FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0 Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages ... Class II Foundation Medicine, Inc.
Nov 8, 2022 FoundationOne CDx (F1CDx), RAL-0003 version 31.0 Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages ... Class II Foundation Medicine, Inc.
Nov 4, 2022 IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests OUS, excep... Potential for falsely elevated specific IgE mold allergen reactivity with quality control materia... Class II Siemens Healthcare Diagnostics, Inc.
Nov 4, 2022 IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests (600T)- US. ... Potential for falsely elevated specific IgE mold allergen reactivity with quality control materia... Class II Siemens Healthcare Diagnostics, Inc.
Nov 4, 2022 IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests Japan Sie... Potential for falsely elevated specific IgE mold allergen reactivity with quality control materia... Class II Siemens Healthcare Diagnostics, Inc.
Nov 1, 2022 Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 16 Fr/Ch ... Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine... Class II Cardinal Health
Nov 1, 2022 Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Cathet... Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine... Class II Cardinal Health
Nov 1, 2022 Dover Closed Urethral Tray with Vinyl Catheter Product Code: 3420 Intended... Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine... Class II Cardinal Health
Nov 1, 2022 Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Cathet... Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine... Class II Cardinal Health
Nov 1, 2022 Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 14 Fr/Ch ... Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine... Class II Cardinal Health
Nov 1, 2022 Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 ml) 5ml Catheter... Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine... Class II Cardinal Health
Oct 25, 2022 IMMULITE and IMMULITE 1000 Total Testosterone Assay- In vitro diagnostic use ... Confirmed an average positive bias of 40% for testosterone concentrations of approximately 660 ng... Class II Siemens Healthcare Diagnostics, Inc.
Oct 24, 2022 Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Blue Electric Heating Pa... The products may have the potential to burn customers. Firm has received complaints of burns, mil... Class I Whele LLC DBA Perch
Oct 24, 2022 Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Grey Electric Heating P... The products may have the potential to burn customers. Firm has received complaints of burns, mil... Class I Whele LLC DBA Perch
Oct 24, 2022 Mighty Bliss Electric Heating Pad, Extra-Large (20 x 24 ) Blue Electric Heat... The products may have the potential to burn customers. Firm has received complaints of burns, mil... Class I Whele LLC DBA Perch
Oct 21, 2022 Philips ProxiDiagnost N90 1.0 (Model 706100) and ProxiDiagnost N90 1.1 (Mode... Potential table stop due to a broken tabletop cable: On the ProxiDiagnost N90 table there is a c... Class II Philips North America Llc
Oct 17, 2022 18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly,... The firm has become aware of PDM battery issues, including battery swelling, fluid leaking from t... Class I Insulet Corporation
Oct 10, 2022 ORISE ProKnife Procedure Kits: indicated for use in gastrointestinal endoscop... ***Update12/13/22***:Product removal due to higher incidence of adverse events of foreign body re... Class II Boston Scientific Corporation
Oct 10, 2022 ORISE Gel Syringe Submucosal Lifting Agent Kits: indicated for use in gastroi... ***Update12/13/22***:Product removal due to higher incidence of adverse events of foreign body re... Class II Boston Scientific Corporation
Oct 10, 2022 ORISE Gel Submucosal Lifting Agent--Indicated for use in gastrointestinal end... ***Update12/13/22***:Product removal due to higher incidence of adverse events of foreign body re... Class II Boston Scientific Corporation
Oct 10, 2022 Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a ... IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions f... Class II Hologic, Inc
Oct 4, 2022 NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallo... The "Nominal Chemical Composition" section of the label incorrectly lists 5.62g/L KCL (potassium ... Class II Fresenius Medical Care Holdings, Inc.
Oct 3, 2022 Blinq Pediatric Vision Scanner-Pediatric Vision Scanner-intended for automate... Unable to charge the battery pack- battery packs will allow the batteries to be charged if the vo... Class II Rebiscan, Inc.
Sep 30, 2022 Beaver Arthro-Lok Pointed Tip Curve L 4mm Blade-an orthopedic blade, which ma... Incorrect configuration of the blades in the package. The blades curve to the right instead of cu... Class II Beaver Visitec International, 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.