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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

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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

3,505 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,505 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 3,505 FDA device recalls in MA.

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DateProductReasonClassFirm
May 29, 2019 Zyno Medical Administration Set -105"ADMIN SET 20DP, W/2 Y SITE, CVCLMPS- For... Administration sets assembled with inverted pinch clamp cause the fluid from the distal end of th... Class II Zyno Medical LLC
May 29, 2019 Stratus CS Acute Care cTNI TestPak, SMN 10445071 Product Usage: In vitro ... Potential for increased rate of false positive results and/or increased rate of random non-repeat... Class II Siemens Healthcare Diagnostics Inc
May 29, 2019 Zyno Medical Administration Set -105"ADMIN SET 20DP W/FILTER 2YSITES CLMP- Fo... Administration sets assembled with inverted pinch clamp cause the fluid from the distal end of th... Class II Zyno Medical LLC
May 28, 2019 Nimbus Administration Set, REF HS-004, UDI # 00817170020031 Product Usage:... Potential for tube leakage Class II InfuTronix LLC
May 6, 2019 Samsung GM85 Mobile Digital X-ray Imaging System Product Usage: The GM85... Potential issue related to the operation of the safety latch within the column that supports the ... Class II NeuroLogica Corporation
May 1, 2019 Medtronic 0-arm TM 1000 Imaging Systems: Bl-700-00027-XXX and B1-700-00028-XX... The 0-arm 1000 Imaging System uses energy from the batteries to generate X-rays and move the syst... Class II Medtronic Navigation, Inc.-Littleton
Apr 30, 2019 Monoject Blunt Cannula, 19 G x 1-1/2" (1.067 mm x 3.8 cm) Item code: 88812... Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject" 201 Vet Pak Hypodermic Needle, 16 ga x 1-1/2 Item code: 8881201654 Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject Standard Hypodermic Needle, 16 G x 1-1/2" Item code: 8881200037 Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject Standard Hypodermic Needle, 18 G x 1-1/2" Item code: 8881200078 Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject 201 Vet Pak Hypodermic Needle, 18 ga x 1-1/2 Item code: 8881201548 Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject Blunt Cannula, 20 G x 1-1/2" (0.902 mm x 3.8 cm) Item code: 88812... Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject Blunt Cannula, 15 G x 1-1/2" (1.829 mm x 3.8 cm) Item code: 88812... Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject 201 Vet Pak Hypodermic Needle, 20 ga x 1-1/2" Item code: 8881201498 Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject 201 Vet Pak Hypodermic Needle, 22 ga x 1-1/2" Item code: 8881201456 Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject 201 Vet Pak Hypodermic Needle, 19 ga x 1-1/2 Item code: 8881201522 Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject Blunt Cannula, 22 G x 1-1/2" (0.711 mm x 3.8 cm) Item code: 88812... Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject Standard Hypodermic Needle, 14 G x 1-1/2" Item code: 8881200011 Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject Blunt Cannula, 16 G x 1-1/2" (1.651 mm x 3.8 cm) Item code: 8881202322 Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject Standard Hypodermic Needle, 16 G x 1-1/2" Item code:8881200045 Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject Standard Hypodermic Needle Item code: 8881200029 Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject Standard Hypodermic Needle, 27 G x 1-1/4" Item code: 8881200508 Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject Standard Hypodermic Needle, 20 G x 1-1/2" bulk Item code: 888120... Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 29, 2019 Philips Patient Information Center iX configured with a regional setting whic... Infusion Pump Data Storage Accuracy-Data from the BBraun Space LAN or Arcomed UniqueDoc infusion ... Class III Philips North America, LLC
Apr 29, 2019 Philips IntelliBridge System configured with a regional setting which uses a ... Infusion Pump Data Storage Accuracy-Data from the BBraun Space LAN or Arcomed UniqueDoc infusion ... Class III Philips North America, LLC
Apr 29, 2019 MAHURKAR and Argyle acute hemodialysis catheters, Material numbers 8813793009... The priming volume values printed on the MAHURKA and Argyle acute catheters and Instructions for ... Class II COVIDIEN LLC
Apr 19, 2019 SureSigns VS4 NBP, SpO2, Product Number 863283. For monitoring the physiolog... System software inhibits the monitor and as a result does not measure, display and alarm for puls... Class II Philips North America, LLC
Apr 19, 2019 SureSigns VS3 NBP, Product Number 863069. For monitoring the physiological p... System software inhibits the monitor and as a result does not measure, display and alarm for puls... Class II Philips North America, LLC
Apr 19, 2019 SureSigns VS3 NBP, SpO2, Rec, Product Number 863072. For monitoring the phys... System software inhibits the monitor and as a result does not measure, display and alarm for puls... Class II Philips North America, LLC
Apr 19, 2019 SureSigns VS4 Government Bundle, Product Number 863286. For monitoring the p... System software inhibits the monitor and as a result does not measure, display and alarm for puls... Class II Philips North America, LLC
Apr 19, 2019 SureSigns VS3 NBP, SpO2, Product Number 863071. For monitoring the physiolog... System software inhibits the monitor and as a result does not measure, display and alarm for puls... Class II Philips North America, LLC
Apr 19, 2019 SureSigns VS3 NBP, SpO2, Temp, Rec, Product Number 863074. For monitoring th... System software inhibits the monitor and as a result does not measure, display and alarm for puls... Class II Philips North America, LLC
Apr 19, 2019 SureSigns VS3 NBP, SpO2, Temp, Product Number 863073. For monitoring the phy... System software inhibits the monitor and as a result does not measure, display and alarm for puls... Class II Philips North America, LLC
Apr 19, 2019 SureSigns VS3 NBP Temp, Product Number 863070. For monitoring the physiologi... System software inhibits the monitor and as a result does not measure, display and alarm for puls... Class II Philips North America, LLC
Apr 12, 2019 OMNIBotics iBlock Cutting Guide, 4146-1000 - Product Usage: The OMNIBotics iB... The OMNIBotics iBlock Cutting Guide does not lock onto the iBlock Saw Guide as intended and may ... Class II OMNIlife science Inc.
Apr 11, 2019 NxStage PureFlow B Solution, REF RFP-400, M535RFP4000 Product NxStage Pure... Certain lots were mislabeled with incorrect product number. Class II NxStage Medical, Inc.
Apr 11, 2019 NxStage PureFlow B Solution, REF RFP-401, M535RPF4010 NxStage PureFlow B S... Certain lots were mislabeled with incorrect product number. Class II NxStage Medical, Inc.
Apr 8, 2019 AURIGA XL 4007 GENERAL - ZERO COST SYSTE UPN: FS4007GZ0 Product Usage: ... Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue... Class II Boston Scientific Corporation
Apr 8, 2019 AURIGA 30 GENERAL - DEMO SYSTEM UPN: M0068S30GD0 Product Usage: The Au... Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue... Class II Boston Scientific Corporation
Apr 8, 2019 Concorde Lift, Lordotic Expandable Interbody Device, spinal fusion implant 9x... A complaint trend was observed for post-operative loss of height and migration for Concorde Lift ... Class II DePuy Spine, Inc.
Apr 8, 2019 AURIGA XL 4007 GENERAL - DEMO SYSTEM UPN: M0068FS4007GD0 Product Usage: ... Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue... Class II Boston Scientific Corporation
Apr 8, 2019 Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21... A complaint trend was observed for post-operative loss of height and migration for Concorde Lift ... Class II DePuy Spine, Inc.
Apr 8, 2019 AURIGA XL 4007 GENERAL SYSTEM UPN: M0068FS4007G0 Product Usage: The Aur... Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue... Class II Boston Scientific Corporation
Apr 8, 2019 AURIGA 30 GENERAL SYSTEM UPN: M0068S30G0 Product Usage: The Auriga XL ... Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue... Class II Boston Scientific Corporation
Apr 8, 2019 AURIGA 30 BRAZIL SYSTEM UPN: M0068S30B0 Product Usage: The Auriga XL 4... Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue... Class II Boston Scientific Corporation
Apr 8, 2019 AURIGA XL 4007 BRAZIL SYSTEM Model: M0068FS4007B0 Product Usage: The A... Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue... Class II Boston Scientific Corporation
Apr 8, 2019 AURIGA 30 GENERAL ZERO COST SYSTEM UPN: M0068S30GZ0 Product Usage: The... Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue... Class II Boston Scientific Corporation
Apr 8, 2019 AURIGA 30 BRAZIL ZERO COST SYSTEM UPN: M0068S30BZ0 Product Usage: The A... Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue... Class II Boston Scientific Corporation
Apr 3, 2019 2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 1... Power Logic Board Fail Message on the 2008T BlueStar Machine with software version 2.72. Class III Fresenius Medical Care Renal Therapies Group, LLC
Mar 29, 2019 Conformis iTotal Hip Replacement System: HBS-033-00xx-020101, (HIP-PATIENT S... Discrepancy of 3mm between the values displayed and approved by surgeons in iViews as the neck/he... Class II Conformis, 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.