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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

3,029 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,029 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 3,029 FDA device recalls in 2016.

Clear
DateProductReasonClassFirm
Jun 14, 2016 T095-022, IV Set with 0.22 Micron Filter. Packaged in a Tyvek pouch, with 50 ... WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets D... Class II WalkMed Infusion, LLC
Jun 14, 2016 T090-022V 90" 20 Drop IV Admin Set Needle free Y-Site & 0.22 Fltr. Packaged i... WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets D... Class II WalkMed Infusion, LLC
Jun 14, 2016 T100-000F, 100" IV Set with Free Flow Clip. Packaged in a Tyvek pouch, with 5... WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets D... Class II WalkMed Infusion, LLC
Jun 14, 2016 Stryker AutoPlex System. Model Numbers 0607-687-000, 0605-887-000, 0605-687... The Piston Head can become separated from the Delivery Piston, blocking the injection assembly Va... Class II Stryker Instruments Div. of Stryker Corporation
Jun 14, 2016 Spike Set, 12" Microbore SPM-12. Packaged in a Tyvek pouch, with 50 pouches p... WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets D... Class II WalkMed Infusion, LLC
Jun 14, 2016 T030-000 -30" 20 Drop IV Admin Secondary Set. Packaged in a Tyvek pouch, with... WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets D... Class II WalkMed Infusion, LLC
Jun 14, 2016 T100-000VF, IV Set with Lower Y Site and Free Flow Clip. Packaged in a Tyvek ... WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets D... Class II WalkMed Infusion, LLC
Jun 14, 2016 T090-000W 90" 20 Drop IV Admin Set w/2 Needlefree Y-Sites Back Check Valve. P... WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets D... Class II WalkMed Infusion, LLC
Jun 14, 2016 T100-120F with 1.2 micron filter and FP Clip. Packaged in a Tyvek pouch, with... WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets D... Class II WalkMed Infusion, LLC
Jun 14, 2016 Volker 2080, 2082, S 280 and S 282 series beds with lateral release button. ... The current construction of the side rail latch may not be able to support the full patient weigh... Class II Hill-Rom, Inc.
Jun 14, 2016 T100-022F with 0.22 micron filter and FP Clip. Packaged in a Tyvek pouch, wit... WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets D... Class II WalkMed Infusion, LLC
Jun 14, 2016 Big Bore Oncology tomography X-ray system scanner, model number 728243. The... Socket Head Cap Screws (SHCS) used in the Z-Axis Adjustment Plate were found to be made of stainl... Class II Philips Medical Systems (Cleveland) Inc
Jun 14, 2016 T100-000WF, IV Set with Upper Y-Site, Lower Y-Site, Back Check Valve, and Fre... WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets D... Class II WalkMed Infusion, LLC
Jun 14, 2016 T090-000 90" 20 Drop IV Admin Set. Packaged in a Tyvek pouch, with 50 pouches... WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets D... Class II WalkMed Infusion, LLC
Jun 14, 2016 The pump (with cushioning foam inserts) is packaged in a single pump box. Fou... WalkMed Infusion, LLC Announces a Voluntary Field Action of the Triton Infusion Pump (model 30000... Class II WalkMed Infusion, LLC
Jun 14, 2016 T105-000WC IV Set w/2 Y-Sites, BC Vlv & Filter Cap. Packaged in a Tyvek pouch... WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets D... Class II WalkMed Infusion, LLC
Jun 14, 2016 T100-022WF, IV Set with 2 Y-Sites, 0.22 micron filter, Back Check Valve, & FP... WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets D... Class II WalkMed Infusion, LLC
Jun 14, 2016 Big Bore Radiology tomography X-ray system scanner, model number 728244. Th... Socket Head Cap Screws (SHCS) used in the Z-Axis Adjustment Plate were found to be made of stainl... Class II Philips Medical Systems (Cleveland) Inc
Jun 14, 2016 The pump (with cushioning foam inserts) is packaged in a single pump box. Fou... WalkMed Infusion, LLC Announces a Voluntary Field Action of the Triton Infusion Pump (model 30000... Class II WalkMed Infusion, LLC
Jun 14, 2016 T095-120 IV Set with 1.2 Micron Filter. Packaged in a Tyvek pouch, with 50 po... WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets D... Class II WalkMed Infusion, LLC
Jun 13, 2016 Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure o... Potential sterility deficiency. Class II Biomet Microfixation, LLC
Jun 13, 2016 ViperWire Advance Peripheral Guide Wire, Sterilized with Ethylene Oxide, Rx O... The pouch label was missing the use by date (UBD) of 2018-04. Class II Cardiovascular Systems Inc
Jun 13, 2016 Richard Allan Scientific 10% Neutral Buffered Formalin, Part Number: 53901 a... potential contamination with potassium hydroxide may have an impact when performing immunohistoch... Class II Richard-Allan Scientific Company
Jun 10, 2016 TSP Hip Fracture Plating System device, fixation, proximal femoral, implant ... The screw may fracture at the junction of the shaft and the head during implantation. The patient... Class II Biomet, Inc.
Jun 10, 2016 Dako HER2 CISH pharmDx Kit, product code: SK 109 Product Usage: For in vi... An incorrect HER2 probe concentration was used when producing the probe component (Vial 3) in thi... Class II Dako North America Inc.
Jun 10, 2016 Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S000... Medtronic has voluntarily decided to retrieve unused Model 3387S-40 and 3389S-40 DBS leads from t... Class II Medtronic Neuromodulation
Jun 9, 2016 FUJIFILM Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Posit... If an exposure is aborted during a stereo biopsy workflow, an error may occur which would prevent... Class II Fujifilm Medical Systems U.S.A., Inc.
Jun 9, 2016 Angiographic Injector and Syringe, MEDRAD MRXperion MR Injection System, MEDR... Bayer Healthcare is initiating this recall due to complaints that were received from customer sit... Class II Bayer Healthcare
Jun 8, 2016 Peripherally Inserted Central Catheters (PICC), UPN H965750191, Catalog # 75-... There is a potential for stylet stiffening that is not accurately represented on the labeling. Th... Class II Angiodynamics Inc. (Navilyst Medical Inc.)
Jun 8, 2016 Sarns TCM II; The Sarns Temperature Control and Monitor unit (TCM) II (sy... Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler ... Class II Terumo Cardiovascular Systems Corporation
Jun 8, 2016 HX2" Temperature Management Systems; The Terumo¿ HX2" Temperature Managem... Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler ... Class II Terumo Cardiovascular Systems Corporation
Jun 8, 2016 Access Free T3 Assay, Ref No. A13422 The Access Free T3 assay is a paramag... Demonstrate an upward shift in patient results. Class II Beckman Coulter Inc.
Jun 8, 2016 HeartWare Ventricular Assist System Controller Product Usage: For use as... Loose connector ports in controller body. Class I Heartware, Inc.
Jun 8, 2016 Preamendments device-Sarns Dual Cooler-Heater. The Sarns Dual Cooler-He... Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler ... Class II Terumo Cardiovascular Systems Corporation
Jun 8, 2016 Peripherally Inserted Central Catheters (PICC), UPN H965750141, Catalog # 75-... There is a potential for stylet stiffening that is not accurately represented on the labeling. Th... Class II Angiodynamics Inc. (Navilyst Medical Inc.)
Jun 8, 2016 GE Healthcare, Discovery MR750w GE Healthcare has recently become aware of a potential safety issue with the patient bore heating... Class II GE Healthcare, LLC
Jun 8, 2016 AMD-Ritmed Transparent Dressing - Window with label, 4 " x 4 3/4" (10 cm x 1... The lot of transparent dressing was found to be contaminated (not sterile) based on FDA sampling ... Class II Amd-Ritmed, Inc.
Jun 8, 2016 Sarns TCM; The Sarns Temperature Control and Monitor unit (TCM) is a sour... Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler ... Class II Terumo Cardiovascular Systems Corporation
Jun 7, 2016 Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as o... Instructions For Use had incorrect lot number and calibrator values Class III Tosoh Bioscience, Inc.
Jun 7, 2016 Depuy Synthes Trauma- Trochanteric Fixation Nail Advanced (TFNA) Blade/Screw ... DePuy Synthes is initiating a voluntary medical device recall due to Blade/Screw Guide Sleeves (P... Class II Synthes (USA) Products LLC
Jun 6, 2016 Target Detachable Coils: TARGET HELICAL NANO 3MM X 4CM MODEL Number:M003545... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET 360 NANO 1 MM X 2 CM MODEL Number: M0035421... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Covidien Cytosponge Cell Collection Device. Item code CYTO-101-01. Gastro... Medtronic is recalling all lots of the Covidien Cytosponge Cell Collection device after two repor... Class II Covidien, LLC
Jun 6, 2016 Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 4 CM MODEL Number:M00... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET 360 NANO 3MM X 6CM MODEL Number:M0035443060... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET HELICAL NANO 3MM X 8CM MODEL Number:M003545... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET 360 NANO 2MM X 3CM MODEL Number:M0035442030... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 SYNGO Breast Care, visualization and image enhancement tools to aid radiolog... Software issues. Siemens is voluntarily initiating a recall after they became aware of the follow... Class II Siemens Medical Solutions USA, Inc
Jun 6, 2016 Target Detachable Coils: TARGET HELICAL NANO 2MM X 3CM MODEL Number:M003545... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET 360 NANO 1.5 MM X 2 CM MODEL Number: M00354... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular

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.