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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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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

3,010 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,010 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 3,010 FDA device recalls in 2019.

Clear
DateProductReasonClassFirm
Mar 21, 2019 ConMed Anchor Tissue Retrieval System 15 MM, 1550 ML (3/BX) Catalog Number: ... Voids in the seal or a partial seal results in an open channel and may compromise the sterility o... Class II Conmed Corporation
Mar 21, 2019 Regard ¿ custom surgical pack labeled as "LAPAROSCOPIC - OSU" including recal... Resource Optimization & Innovation (ROi) has received a recall notice from Stryker regarding tube... Class II ROi Consolidated Service Center (CSC)
Mar 21, 2019 ConMed Anchor Tissue Retrieval System 10 MM, 235 ML, (5/BX) Catalog Number: ... Voids in the seal or a partial seal results in an open channel and may compromise the sterility o... Class II Conmed Corporation
Mar 20, 2019 Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg Produ... Edi Catheter labeled with wrong expiry date on single pack EDI catheter boxes Class III GETINGE US SALES LLC
Mar 20, 2019 Discovery NM 630 Product Usage: The Discovery NM 630 is an all-purpose du... During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some... Class II GE Healthcare, LLC
Mar 20, 2019 VITROS XT 7600 Integrated System, with V3.4 or 3.4.1 SW Product Code: 684446... Potential for sample fluid to be dispensed to an incorrect position on the MicroSlide, potentiall... Class II Ortho-Clinical Diagnostics
Mar 20, 2019 Discovery NM/CT 670 ES Product Usage: The GE Discovery NM/CT 670 system is... During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some... Class II GE Healthcare, LLC
Mar 20, 2019 Discovery NM/CT 670 CZT, Model/Catalogue/Code H3906CT Product Usage: The ... During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some... Class II GE Healthcare, LLC
Mar 20, 2019 NM/CT 850 Product Usage: The GE NM/CT 850 system is intended for general ... During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some... Class II GE Healthcare, LLC
Mar 20, 2019 NM/CT 860 Product Usage: The GE NM/CT 860 system is intended for gene... During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some... Class II GE Healthcare, LLC
Mar 20, 2019 NM 830 Product Usage: The Discovery NM 630 is an all-purpose dual detecto... During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some... Class II GE Healthcare, LLC
Mar 20, 2019 Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is intende... During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some... Class II GE Healthcare, LLC
Mar 20, 2019 Siemens Digital Linear Accelerators of type: ARTISTE MV System MEVATRON M2/... Advisory issued not to disable or bypass the AMP function. Disabling or bypassing the AMP functio... Class II Siemens Medical Solutions USA, Inc
Mar 20, 2019 Discovery NM/CT 670 DR Product Usage: The GE Discovery NM/CT 670 system i... During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some... Class II GE Healthcare, LLC
Mar 20, 2019 NM/CT 870 DR Product Usage: The GE Discovery NM/CT 670 system is a medica... During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some... Class II GE Healthcare, LLC
Mar 20, 2019 NM/CT 870 CZT, Model/Catalogue/Code # H3906CW Product Usage: The GE Disco... During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some... Class II GE Healthcare, LLC
Mar 19, 2019 Performance Series Sagittal Blade, Catalog Number 6125-127-100 Product Usa... During manufacture, packaging materials for a small portion of the lot may not have been properly... Class II Stryker Instruments Div. of Stryker Corporation
Mar 19, 2019 AIR Technology Anterior Array, Catalogue Numbers: (a) 5746694, (b) 5746695, ... The outer seam of the coil, closest to the system cable, may separate and expose the porous mater... Class II GE Healthcare, LLC
Mar 19, 2019 Neomem Resorbable Collagen Membrane, 15 mm x 20 mm Reference Number (model):... Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead ... Class II Collagen Matrix, Inc.
Mar 19, 2019 BIOPHEN UFH Control C2, REF 223901 The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for t... Class III Aniara Diagnostica LLC
Mar 19, 2019 BIOPHEN LMWH Control C4, REF 224201 The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for t... Class III Aniara Diagnostica LLC
Mar 19, 2019 BIOPHEN UFH Control C1, REF 224101 The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for t... Class III Aniara Diagnostica LLC
Mar 19, 2019 OnSight 3D Extremity System- X-Ray, Tomography Computed System Catalog Numbe... When the user performs the re-assignment of a parent / companion pair, the parent volume is trans... Class II Carestream Health, Inc.
Mar 18, 2019 Cios Alpha, Model Number 10308191 Mobile X-ray system - Product Usage: The C... Continuous operation at very high tube output may result in increased wear of the radiation emitt... Class II Siemens Medical Solutions USA, Inc
Mar 18, 2019 Albumin BCP Product Usage: ALBP is an in vitro test used for the quantit... The reagent lot is exhibiting calibration failures, QC imprecision, and elevated QC recovery due ... Class II Roche Diagnostics Corporation
Mar 18, 2019 MRIdian Linac Radiation Therapy System, Model 20000. A discrepancy between optimization and planning forward dose calculation between adaptive optimiz... Class II Viewray, Inc.
Mar 18, 2019 HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode RE... Three materials used in the makeup of the implant were mistakenly left off the list of bio-compat... Class III Advanced Bionics, LLC
Mar 18, 2019 CS011 GNR PNA FISH Control Slide, manufactured as a component of the CS011-10... May show diminished performance prior to its established expiration date resulting in an invalid ... Class II Opgen Inc
Mar 18, 2019 IDEAL IMPLANT Structured Breast Implant, saline breast implant, in the follow... The implants were deflating due to a piece of silicone disrupting the seal of the posterior valve... Class II Ideal Implant Incorporated
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 Innova IGS 630, Interventional Fluoroscopic X-Ray System used in generating f... There is a potential for loss of the x-ray imaging function when the user changes field of view (... Class II GE Healthcare, LLC
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

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.