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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

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

2,729 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,729 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 2,729 FDA device recalls in 2014.

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DateProductReasonClassFirm
Jul 18, 2014 Prisma HF1000 preset (new design). Product number 107639. Each set is package... Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors ... Class II Gambro Renal Products, Incorporated
Jul 18, 2014 Prismaflex HF 1000. Product number 107140. Each set is packaged in a plastic ... Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors ... Class II Gambro Renal Products, Incorporated
Jul 18, 2014 RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage:... RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister... Class II Smith & Nephew, Inc.
Jul 18, 2014 X-MARS Set (component of MARS Treatment Kit Type 1116/1 X-MARS US), Product ... Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors ... Class II Gambro Renal Products, Incorporated
Jul 18, 2014 Single Line Transpac IV Monitoring Kit w/03 ml Squeeze Flush Device, CSP and ... ICU has become aware of an issue with a component where the connection on an arterial monitoring ... Class II ICU Medical, Inc.
Jul 18, 2014 Prismaflex M150. Product number 109990. Each set is packaged in a plastic pou... Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors ... Class II Gambro Renal Products, Incorporated
Jul 18, 2014 Trifurcated Transpac IT Monitoring Kit w/03 ml Flush Devices, Needleless Valv... ICU has become aware of an issue with a component where the connection on an arterial monitoring ... Class II ICU Medical, Inc.
Jul 18, 2014 Prisma TPE 2000 set. Product number 109672. Each set is packaged in a plastic... Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors ... Class II Gambro Renal Products, Incorporated
Jul 18, 2014 Prisma M 60 PRE set (new design). Product number 103658. Each set is packaged... Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors ... Class II Gambro Renal Products, Incorporated
Jul 18, 2014 RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage:... RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister... Class II Smith & Nephew, Inc.
Jul 18, 2014 Transpac IV Trifurcated Monitoring Kit w/84" Safeset Reservoir, 03 ml Squeeze... ICU has become aware of an issue with a component where the connection on an arterial monitoring ... Class II ICU Medical, Inc.
Jul 18, 2014 Prisma M 100 PRE set. Product number 103657. Each set is packaged in a plasti... Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors ... Class II Gambro Renal Products, Incorporated
Jul 17, 2014 Pedi-Pak Pedi-Syringe Filter 30 mL Becton Dickinson Syringe Rx Only Genesis ... Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to i... Class II Genesis BPS, LLC.
Jul 17, 2014 Pedi-Pak Pedi-Syringe Filter 35 mL Monoject Syringe Rx Only Genesis BPS, LLC... Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to i... Class II Genesis BPS, LLC.
Jul 17, 2014 Vital Sync RMS 1.0 when loaded with v2.4 software, packaged on a CD or other ... Covidien is conducting a field correction of the Vital Sync Virtual Patient Monitoring Platform a... Class II Nellcor Puritan Bennett Inc. (dba Covidien LP)
Jul 17, 2014 Tapered-Screw Vent Implant, HA, 4.7mmD x 8mmL x 4.5mm, Part No. TSVWH8 Denta... Zimmer Dental is recalling the Tapered Screw-Vent Implant because the inner vial state "03.7 x 8m... Class II Zimmer, Inc.
Jul 17, 2014 Vital Sync" VPMP & IM, software, V2.4. (DVD), packaged on a CD or other elect... Covidien is conducting a field correction of the Vital Sync Virtual Patient Monitoring Platform a... Class II Nellcor Puritan Bennett Inc. (dba Covidien LP)
Jul 17, 2014 CloverSnare 4-Loop Vascular Retrieval Snare. Product is packaged in a Tyvek-... This remedial action is the result of six product complaints associated with separation of the sn... Class I Cook Inc.
Jul 17, 2014 PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve The Instructions for Use for the Pentax OF-B130 and OF-B194 Gas/Water Valve IFU if not followed c... Class II Pentax Medical Company
Jul 17, 2014 Pedi-Pak Pedi-Syringe Filter 60 mL Becton Dickinson/Monoject Syringe Rx Only... Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to i... Class II Genesis BPS, LLC.
Jul 17, 2014 TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003... Accuray is voluntarily recalling TomoTherapy H Series software versions 1.2.0, 1.2.1 and 1.2.2 (H... Class II TomoTherapy Incorporated
Jul 16, 2014 Henry Schein Natural Elegance SE Bond Self-Etch Light-Cure Adhesive contains... Septodont is recalling Self-Etch bond because the material was incorrectly packaged. Class II Novocol, Inc.
Jul 16, 2014 Instructions for Use for the blue endo MOREsolution Electromechanical Laparos... Some pages of the Instructions for Use were omitted, including pages regarding the Indications fo... Class II Market-Tiers Inc
Jul 16, 2014 Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic devices... The Reagent Lid hinge may lose its effectiveness and slowly shift downward during maintenance pro... Class II Siemens Healthcare Diagnostics, Inc.
Jul 16, 2014 Darby Dental Supply Compolite Bond SE Self-Etch/Light-Curing. This product i... Septodont is recalling Self-Etch bond because the material was incorrectly packaged. Class II Novocol, Inc.
Jul 16, 2014 VITROS¿ Immunodiagnostic Products CA 19-9 Calibrators and Reagent Packs, Lot ... Customers may receive positively biased results when using VITROS¿ Immunodiagnostic Products CA 1... Class II ORTHO-CLINICAL DIAGNOSTICS
Jul 16, 2014 Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF-004355;... Some sheets of the medical screen film are fogged. Class III AGFA Healthcare Corp.
Jul 16, 2014 TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003... Accuray is voluntarily recalling TomoTherapy H Series software versions 2.0.0 and 2.0.1 (Hi-Art¿ ... Class II TomoTherapy Incorporated
Jul 15, 2014 Siemens Dimension Chemistry Wash (RD701) is an accessory of the flex cartridg... Siemens Healthcare Diagnostics has received complaints for the Dimension Chemistry Wash (RD701) o... Class II Siemens Healthcare Diagnostics, Inc.
Jul 15, 2014 VITROS¿ Chemistry Products CDM PROM Calibration Data Module Rev. No. 0168 and... Inability to calibrate or use VITROS NH3 DT Slides, GEN 59 with VITROS Chemistry Products DT Cali... Class II Ortho-Clinical Diagnostics
Jul 15, 2014 Gelweave (TM) Vascular Prostheses Manufactured by - VASCUTEK Ltd a TERUMO c... The cautery that is provided with the Gelweave graft in the box has a shorter shelf life indicate... Class II Vascutek, Ltd.
Jul 15, 2014 AB SCIEX API 3200MD" LC/MS/MS System with software: MultiQuantMD 3.0In vit... Software- AB SCIEX API 3200MD LC/MS/MS SYSTEM with MultiQuantMD 3.0 software may provide incorrec... Class II Ab Sciex
Jul 14, 2014 Medtronic, Activa PC, Model 37601, Method of Sterilization: Ethylene Oxide, S... Medtronic is recalling six Activa PC (model 37601) Implantable Neurostimulators due to the potent... Class II Medtronic Neuromodulation
Jul 14, 2014 ***Baxter***BURETROL Solution Set***105" (2.7 m) 150 mL Burette***Drip Chamb... Baxter Healthcare Corporation is voluntarily issuing a recall for specific lots of Buretrol Solut... Class II Baxter Healthcare Corp
Jul 14, 2014 ***Baxter***Non-DEHP***BURETROL Solution Set 105" (2.7 m), 150 mL Burette***... Baxter Healthcare Corporation is voluntarily issuing a recall for specific lots of Buretrol Solut... Class II Baxter Healthcare Corp
Jul 14, 2014 ***Baxter***Buretrol Solution Set***105" (2.7 m)***150 mL Burette***Drip Cham... Baxter Healthcare Corporation is voluntarily issuing a recall for specific lots of Buretrol Solut... Class II Baxter Healthcare Corp
Jul 11, 2014 Patella 38mm, REF164-0038 Product Usage: UHMWPE component used in a TKA ... Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila In... Class II Ortho Development Corporation
Jul 11, 2014 FlowCOUPLER. An implantable device that is used to detect blood flow in ves... Baxter Healthcare is recalling the FlowCOUPLER Device because there is a possibility that some un... Class II Baxter Healthcare Corporation
Jul 11, 2014 Pivot Bipolar Cup 22x42/43-51/53mm, REF 133-YYYY Product Usage: Used in a... Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila In... Class II Ortho Development Corporation
Jul 11, 2014 Amerigel Post-Op Surgical Kits . Kit includes: Amerigel Wound Dressing, Amer... Not approved labeling claims (antimicrobial and autolytic debridement) Class II Amerx Health Care Corp.
Jul 11, 2014 PS Tibial Insert, REF 163-1XXX Product Usage: UHMWPE component used in TK... Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila In... Class II Ortho Development Corporation
Jul 11, 2014 Tibila Insert CK, Balanced Knee System Revision, REF563-1YYY Product Usage... Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila In... Class II Ortho Development Corporation
Jul 11, 2014 Medtronic Ascenda Intrathecal Catheter models 8780 and 8781, and Ascenda Intr... Medtronic is removing specific lots of the Ascenda Intrathecal Catheters and Revision Kits, which... Class II Medtronic Neuromodulation
Jul 11, 2014 Luma Wrap Phototherapy Swaddler is designed to provide centered and comfortab... Beevers Manufacturing & Supply Inc. is recalling Luma Wrap neonatal phototherapy blankets because... Class II Beevers Manufacturing & Supply, Inc.
Jul 11, 2014 Amerigel Wound Dressing Maximum Strength CAT# A2001. Wound management. Not approved labeling claims (antimicrobial and autolytic debridement) Class II Amerx Health Care Corp.
Jul 11, 2014 Amerigel Daily Dressing Advanced 3-in-1 Hydrogel; 30 single used foil packets... Not approved labeling claims (antimicrobial and autolytic debridement) Class II Amerx Health Care Corp.
Jul 11, 2014 Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the S... Revision B of the tissue shields of the device was 7 mm longer than the previous design. Class II X Spine Systems Inc
Jul 11, 2014 Amerigel Hydrogel Saturated Gauze Dressing; 10 Individually Packaged pads siz... Not approved labeling claims (antimicrobial and autolytic debridement) Class II Amerx Health Care Corp.
Jul 11, 2014 Tibila Insert UC, Balanced Knee System, REF163-3YYY Product Usage: UHMWPE... Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila In... Class II Ortho Development Corporation
Jul 10, 2014 Medical Positioning Rapid Response HUT table, Powered Medical Examination tab... Excessive weight on the table will cause tables with the affected component to drop into the Tren... Class II Medical Positioning 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.