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Vehicle Safety

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 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.
Mar 29, 2019 Conformis iTotal Hip Replacement System: HBS-033-00xx-010101, (HIP-PATIENT S... Discrepancy of 3mm between the values displayed and approved by surgeons in iViews as the neck/he... Class II Conformis, Inc.
Mar 28, 2019 IntelliVue MX40 Patient Monitor, Product number 857146, Service Numbers All: ... The MX40 may experience increased power consumption and may have a lack of visual and/or audible ... Class II Philips North America, LLC
Mar 28, 2019 IntelliVue MX40 Patient Monitor, Product number 865352, Service Numbers All: ... The MX40 may experience increased power consumption and may have a lack of visual and/or audible ... Class II Philips North America, LLC
Mar 28, 2019 IntelliVue MX40 Patient Monitor, Product number 865350, Service # USA: 453564... The MX40 may experience increased power consumption and may have a lack of visual and/or audible ... Class II Philips North America, LLC
Mar 28, 2019 IntelliVue MX40 Patient Monitor, Product number 865351, Service Numbers All ... The MX40 may experience increased power consumption and may have a lack of visual and/or audible ... Class II Philips North America, LLC
Mar 22, 2019 ChemoPlus Chemo Spill Kit Product Code:DP5016K Product Usage: ChemoPlus ... Kit label states not made with natural rubber latex,however safety goggles within the kits contai... Class II Cardinal Health 200, LLC
Mar 22, 2019 TLS2 Thermal Ligating Shears, Catalog Number 132-131D The shears exhibited a high rate of complete or intermittent failure to actuate. As a result, th... Class II Microline Surgical, Inc.
Mar 22, 2019 ChemoPlus Protective Wrap-around Goggles Product Code:DP5030G Product Usa... Kit label states not made with natural rubber latex,however safety goggles within the kits contai... Class II Cardinal Health 200, LLC
Mar 22, 2019 ChemoPlus Chemo Spill Kit, Home Health Kit Product Code:DP5108K Product U... Kit label states not made with natural rubber latex,however safety goggles within the kits contai... Class II Cardinal Health 200, LLC
Mar 22, 2019 ChemoPlus Chemo Spill Kit Product Code:CT4004 Product Usage: ChemoPlus ... Kit label states not made with natural rubber latex,however safety goggles within the kits contai... Class II Cardinal Health 200, LLC
Mar 21, 2019 Prometra II Programmable Pump (Clinical), Cat. No. 01827 For intrathecal in... The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout,... Class II Flowonix Medical Inc
Mar 21, 2019 Prometra II Programmable Pump, Cat. No. 13827 For intrathecal infusion. The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout,... Class II Flowonix Medical Inc
Mar 21, 2019 Prometra Programmer (Grand Prime) Software version 2.00.29, Cat. No. 13828, u... The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout,... Class II Flowonix Medical Inc
Mar 21, 2019 Prometra Clinician Programmer (Touchscreen) Software version 2.00.29, Cat. No... The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout,... Class II Flowonix Medical Inc
Mar 21, 2019 Prometra Programmable Pump, Cat. No. 11827 For intrathecal infusion. The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout,... Class II Flowonix Medical Inc
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR2.0, 100CM.070", REF SA6AR20. for ... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F, RCB SH, 90CM, 070", REF SA6RCBSHD. f... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F LCB SH, .070", REF SA6LCBSH. for card... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F MP ST, .070", REF SA6MPST. for cardio... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR1.0SH 100CM.070", REF SA6AR10SH. f... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F JL4.5, .070", REF SA6JL45. for cardio... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR1.0 100CM.070", REF SA6AR10. for c... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL1.0 110CM .070", REF SA6AL10A. for... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F, NOTO, 100CM, 070", REF SA6NOTO. for ... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F RBU4.0 SH, .070", REF SA6RBU40SH. for... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F, RBU3.5, 100CM, 070", REF SA6RBU35. f... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F ERAD LEFT SH, .070", REF SA6ERADLSH. ... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F, HSI, 100CM, 070", REF SA6HSI. for ca... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL3.0, .070", REF SA6SAL30. for card... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR2.0 SH, 100CM.070", REF SA6AR20SH. ... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F JL4.0, .070", REF SA6JL40. for cardio... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F ALR1-2, .070", REF SA6ALR12. for card... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F AL2.5, .070:, REF SA6AL25. for cardio... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL.75 110CM.070", REF SA6AL75A. for ... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F M RESS, .070", REF SA6MRESS. for card... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F MP1 SH, .070", REF SA6MP1SH. for card... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular

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.