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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
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F AL3.0, .070", REF SA6AL30. 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, CHAMP2.0, 55CM.070", REF SA6CHAMP20K. ... 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 EBU3.5 SH, .070", REF SA6EBU35SH. 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 SAL.75, .070", REF SA6SAL75. 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 CHAMP1.0 SH, .070", REF SA6CHAMP10SH. ... 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, RDND1 55CM .070", REF SA6RDND1K. 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 SL4.0, .070", REF SA6SL40. 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 LARA, .070", REF SA6LARA. for cardiov... 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 EBU4.0 SH, .070", REF SA6EBU40SH. 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 AL.75, .070", REF SA6AL75. 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 CHAMP2.0 SH, .070", REF SA6CHAMP20SH. ... 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 SL5.0, .070", REF SA6SL50. 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 110CM AL20, REF SA6AL20A. for cardiov... 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 90CM, .070", REF SA6LCBD. 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 AL2.0, .070", REF SA6AL20. 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 SL4.5, .070", REF SA6SL45. 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 ERAD RIGHT SHORT TIP, .070", REF SA6ERA... 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, 3DRC 100CM .070", REF SA63DRC. 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 JL3.0 SH, .070", REF SA6JL30SH. 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, .070", REF SA6AL10. for cardio... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 13, 2019 Procedure kits include devices from the affected lots distributed OUS only: ... Sterilization method used was not consistent with the labeling and the approved sterilization method Class II COVIDIEN LLC
Mar 13, 2019 Covidien Endo Grasp Auto Suture Grasper 5mm REF: 173030 The Covidien Endo... Sterilization method used was not consistent with the labeling and the approved sterilization method Class II COVIDIEN LLC
Mar 13, 2019 Covidien Endo Clinch II Auto Suture Grasper, 5mm REF: 174317 The Covidi... Sterilization method used was not consistent with the labeling and the approved sterilization method Class II COVIDIEN LLC
Mar 12, 2019 Beaver Xstar Slit Knife 2.4 mm, 45degree Double Bevel, Ophthalmic-utilized i... Mislabeled. The package labeling indicates a size 2.4mm, 45 degree Double Bevel knife however, th... Class II Beaver Visitec
Mar 12, 2019 Azurion FlexArm, 722079 During manufacturing of an Azurion R2.0 system, it was found out that the cable set was not accor... Class II Philips North America, LLC
Feb 28, 2019 Urodiagnost, Product No. 708033 Product Usage: The Philips UroDiagnost MR... The locking plate may be missing from the system, which may result in unexpected stand/table tilt... Class II Philips North America, LLC
Feb 28, 2019 URODiagnost Eleva, Product codes 708026, 708027, 708028 Product Usage: Th... The locking plate may be missing from the system, which may result in unexpected stand/table tilt... Class II Philips North America, LLC
Feb 28, 2019 MultiDiagnost Eleva w/ Flat Detector, Product codes 708034, 708037, 708038 P... The locking plate may be missing from the system, which may result in unexpected stand/table tilt... Class II Philips North America, LLC
Feb 28, 2019 Omnidiagnost Classic, Product Codes 70859, 708023, 708024, 708025 Product ... The locking plate may be missing from the system, which may result in unexpected stand/table tilt... Class II Philips North America, LLC
Feb 28, 2019 MultiDiagnost-Eleva, Product codes 708032, 708036 Product Usage: As a mul... The locking plate may be missing from the system, which may result in unexpected stand/table tilt... Class II Philips North America, LLC
Feb 22, 2019 Paltop 1.25 Hex Drivers, Long Part Number: 60-70101 Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving... Class II Keystone Dental Inc
Feb 22, 2019 Paltop 1.25 Hex Drivers, Short Part Number: 60-70102 Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving... Class II Keystone Dental Inc
Feb 22, 2019 Paltop Fully Guided Surgical Kit- containing the 1.25mm Hex Driver For surgi... Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving... Class II Keystone Dental Inc
Feb 22, 2019 Paltop Premium Surgical Kit-containing the 1.25mm Hex Driver For surgical an... Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving... Class II Keystone Dental Inc
Feb 19, 2019 Micro Knife 5.0mm 30¿, Part Number 0001522 The Beaver¿ Micro Knife 5.0mm... The product contains a misprinted expiration date on the peel pack. Both were printed as "180615... Class III Beaver Visitec
Feb 15, 2019 Kendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736 The product does not meet sterility requirements. Product labeled as sterile was distributed wit... Class II COVIDIEN LLC
Feb 8, 2019 Omega Systems These devices are intended to be used in the environment whe... The firm is recalling their Delta family of patient monitors software due to cybersecurity vulner... Class II Draegar Medical Systems, Inc.
Feb 8, 2019 Infinity Delta Family patient monitors The Infinity Delta Series (Delta/De... The firm is recalling their Delta family of patient monitors software due to cybersecurity vulner... Class II Draegar Medical Systems, Inc.
Feb 6, 2019 Medica Wash1-Wash solution used prior to Lipase assay on the EasyRA clinical ... Wash1 solution is ineffective in cleaning dispensing probe of TRIG and LDL reagents that interfer... Class II Medica Corporation
Jan 29, 2019 TASE 500 Imaging systems the Nominal Ocular Hazard Distance (NOHD) associated with a Class lllb alignment laser utilized i... Class II COLLINS AEROSPACE
Jan 29, 2019 TASE 400 Imaging systems the Nominal Ocular Hazard Distance (NOHD) associated with a Class lllb alignment laser utilized i... Class II COLLINS AEROSPACE
Jan 25, 2019 Lithium-ion Rechargeable Batteries for the Philips MX40 Wearable Monitor REF:... Lithium-ion Rechargeable Batteries for the Philips MX4O Wearable Monitor may have a manufacturin... Class II Philips North America, LLC
Jan 25, 2019 Obturator (shortcone), Part number 26114 Product Usage: The obturator is ... The weld may break, resulting in the rod separating from the cone of the long and short cone Obtu... Class II Medrobotics Corporation
Jan 25, 2019 Fetal Spiral Electrode, Model No. 9898 031 37631 During use of the Philips FSE, it is possible for the metal electrode tip to break off and remain... Class II Philips North America, LLC
Jan 25, 2019 Obturator (long cone), Part number 25162 Product Usage: The obturator is ... The weld may break, resulting in the rod separating from the cone of the long and short cone Obtu... Class II Medrobotics Corporation
Jan 15, 2019 Fujifilm FDR Go PLUS, Mobile X-Ray System Product Usage: This device is ... FUJIFILM Medical Systems U.S.A., Inc., Modality Systems became aware of the possibility that the ... Class II Fujifilm Medical Systems U.S.A., Inc.
Jan 9, 2019 PageWriter TC50 Government Bundle, Product 860429, Software revisions up to a... Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing ... Class II Philips North America, LLC
Jan 9, 2019 PageWriter TC70 w/o trolley Government Bundle, Product 860353, Software revis... Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing ... Class II Philips North America, LLC
Jan 9, 2019 PageWriter TC70 w/trolley Government Bundle, Product 860352, Software revisio... Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing ... Class II Philips North America, LLC
Jan 9, 2019 PageWriter TC30 w/ trolley Government Bundle, Product 860354, Software revisi... Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing ... 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.