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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

3,029 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
Apr 20, 2016 Acorn 130 Stairlift, Brooks 130 Stairlift, Acorn 180 Stairlift, and Acorn Out... The design of the seats did not consistently have the adequate strength required to support the c... Class II Acorn Stairlifts, Inc
Apr 20, 2016 GE, Revolution CT. The system is intended for head, whole body, cardiac, and... An out of tolerance torque tool was used on three joints during the manufacturing process. If the... Class II GE Medical Systems, LLC
Apr 20, 2016 MX 16-slice whole body computed tomography X-ray system. Imaging diagnostic t... The following issues have been found in MX 16-slice systems with software version 1.1.4.21426: ... Class II Philips Medical Systems (Cleveland) Inc
Apr 20, 2016 Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at ... Due to some cards in this lot experiencing variations in wave form, resulting in some cards with ... Class II Helena Laboratories, Inc.
Apr 20, 2016 MX 16-slice SKD whole body computed tomography X-ray system. Imaging diagnos... The following issues have been found in MX 16-slice systems with software version 1.1.4.21426: ... Class II Philips Medical Systems (Cleveland) Inc
Apr 19, 2016 Surgical Table Cushion (HybriGel Pads) HybrGel Pads are an optional accessor... The Surgical Table Cushion (HybriGel Pads) could potentially contain staples that's secure two un... Class II Berchtold Corp.
Apr 19, 2016 Radionuclide Radiation Therapy System Product The product is a teletherapy... The latches of the frame adapter can be locked even if the locating pins of the frame adapter is ... Class II Elekta, Inc.
Apr 19, 2016 The VITROS¿ Chemistry Products Calibrator Kit 31, Lot 3155 used in conjunctio... There is an incorrect value (data/calibration mathematics) on ADDs. This incorrect value will pr... Class III Ortho-Clinical Diagnostics
Apr 18, 2016 3.2 mm three-fluted Radiolucent Drill Bit/Needle Point/145 mm Sterile Prod... The sterile packaging may be compromised. A protective cap is to be secured on the tip of the dr... Class II Synthes (USA) Products LLC
Apr 18, 2016 3.2 mm Three-fluted drill bit, sterile, Catalog ID # 03.010.060S Product U... The sterile packaging may be compromised. A protective cap is to be secured on the tip of the dr... Class II Synthes (USA) Products LLC
Apr 15, 2016 Volt Resistance Heated Lower Back Garment Deep penetrating heat garment and ... During an FDA inspection it was found that the firm claims unapproved therapy and medical claims ... Class II 2k Innovations Inc.
Apr 15, 2016 GE Healthcare, Discovery IGS 730. Indicated for use in generating fluoroscop... Potential non-recoverable loss of image acquisition. The affected Discovery systems may experie... Class II GE Medical Systems, LLC
Apr 15, 2016 White Lumax Guiding Coaxial Catheter Catheter, Percutaneous Intended for th... Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or ... Class II Cook Inc.
Apr 15, 2016 Merge LIS software. The firm name on the label is Merge Healthcare. Merge... There are potential issues with results reporting for certain run-based tests. Under certain con... Class II Merge Healthcare, Inc.
Apr 15, 2016 Transluminal Biliary Biopsy Forceps Set Forceps, Biopsy, Non-Electric Inten... Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or ... Class II Cook Inc.
Apr 15, 2016 Slip-Cath Beacon Tip Catheter Catheter, Intravascular, Diagnostic The cathe... Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or ... Class II Cook Inc.
Apr 15, 2016 POROUS PATELLA 32MM X 10MM - 00587806532 POROUS PATELLA 35MM X 10MM- 0058... Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal i... Class II Zimmer Trabecular Metal Technology, Inc.
Apr 15, 2016 IG1, IGF-I reagent, Catalog # LKGF1; For the quantitative measurement of insu... 24 minutes of incubation is required prior to processing patient samples and for the pretreatment... Class II Siemens Healthcare Diagnostics, Inc.
Apr 15, 2016 Selective Salpingography Catheter with Beacon Tip Cannula, Manipulator/ Inje... Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or ... Class II Cook Inc.
Apr 15, 2016 Volt Resistance Heated Therapy Foot Wrap Deep penetrating heat garment and w... During an FDA inspection it was found that the firm claims unapproved therapy and medical claims ... Class II 2k Innovations Inc.
Apr 15, 2016 CARESTREAM Image Suite V3: MINI-PACS/F IMG ST/CLASSIC: REF/Catalog # 1036490... Carestream Health received a complaint related to CARESTREAM Image Suite 4 from a foreign hospita... Class II Carestream Health Inc
Apr 15, 2016 00720504022 ACETAB.CUPW/SH,0DEG,22MMX40MM 00720504222 ACETAB.CUPW/SH,0DEG,2... Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal i... Class II Zimmer Trabecular Metal Technology, Inc.
Apr 15, 2016 Ziehm Solo, Mobile C-arm for Mobile Fluoroscopic Imaging Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute time... Class II Ziehm Imaging Inc
Apr 15, 2016 Liver Access and Biopsy Needle Set Biopsy needle kit Intended for use in ob... Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or ... Class II Cook Inc.
Apr 15, 2016 Volt Resistance Heated Neck Garment Deep penetrating heat garment and wraps During an FDA inspection it was found that the firm claims unapproved therapy and medical claims ... Class II 2k Innovations Inc.
Apr 15, 2016 Beacon Tip Centimeter Sizing Catheter Beacon Tip White Vessel Sizing Cathete... Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or ... Class II Cook Inc.
Apr 15, 2016 Haskal Transjugular Intrahepatic Portal Access Set Introducer, catheter Int... Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or ... Class II Cook Inc.
Apr 15, 2016 Ziehm Vision2, Mobile C-arm for Mobile Fluoroscopic Imaging Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute time... Class II Ziehm Imaging Inc
Apr 15, 2016 Kumpe Access Catheter Cathether, Ureteral, General & Plastic Surgery Used i... Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or ... Class II Cook Inc.
Apr 15, 2016 GE Healthcare, Discovery IGS 740. Indicated for use in generating fluoroscop... Potential non-recoverable loss of image acquisition. The affected Discovery systems may experie... Class II GE Medical Systems, LLC
Apr 15, 2016 REV. SHELL LINER 0D 28X48 00700504828 REV. SHELL LINER 10D 28X50 007010050... Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal i... Class II Zimmer Trabecular Metal Technology, Inc.
Apr 15, 2016 Volt Resistance Unisex Rechargeable Heated Slipper (All sizes) Deep penetra... During an FDA inspection it was found that the firm claims unapproved therapy and medical claims ... Class II 2k Innovations Inc.
Apr 15, 2016 Beacon Tip Torcon NB Advantage Catheter Catheter, Intravascular, Diagnostic Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or ... Class II Cook Inc.
Apr 15, 2016 VIDAS NT-pro-BNP Product Usage: VIDAS¿ NTproBNP (PBNP) is an automated qu... Due to a packaging error; The kit does not contain the correct number of C1 or C2 control vials. Class III Biomerieux France Chemin De L'Or
Apr 15, 2016 Volt Resistance Heated Elbow Garment Deep penetrating heat garment and wraps During an FDA inspection it was found that the firm claims unapproved therapy and medical claims ... Class II 2k Innovations Inc.
Apr 15, 2016 Given Imaging Bravo¿¿ pH capsule delivery device, 1-pack. In- Vitor Diagnost... Potential of an allergic reaction in a patient with nickel sensitivity. Class II Covidien LLC
Apr 15, 2016 TM CR TIB SZ 3 C-H, 10MM- 00588604310 TM CR TIB SZ 3 C-H, 12 mm - 005886... Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal i... Class II Zimmer Trabecular Metal Technology, Inc.
Apr 15, 2016 Ziehm Vision RFD, Mobile C-arm for Mobile Fluoroscopic Imaging Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute time... Class II Ziehm Imaging Inc
Apr 15, 2016 FluoroSet Radiographic Tubal Assessment Set Cannula, Manipulator/ Injector, ... Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or ... Class II Cook Inc.
Apr 15, 2016 CARESTREAM Image Suite V4; Image Suite V4: DICOM STORE SCP: REF/Catalog # 1... Carestream Health received a complaint related to CARESTREAM Image Suite 4 from a foreign hospita... Class II Carestream Health Inc
Apr 15, 2016 TM MONO TIB STR GRN SZ 5 - 00588606510 TM MONO TIB STR GRN SZ 5 12MM - 00588... Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal i... Class II Zimmer Trabecular Metal Technology, Inc.
Apr 15, 2016 Volt Resistance Heated Therapy Shoulder Wrap Deep penetrating heat garment a... During an FDA inspection it was found that the firm claims unapproved therapy and medical claims ... Class II 2k Innovations Inc.
Apr 15, 2016 Volt Resistance Heated Socks (All sizes) Deep penetrating heat garment and w... During an FDA inspection it was found that the firm claims unapproved therapy and medical claims ... Class II 2k Innovations Inc.
Apr 15, 2016 Beacon Tip Royal Flush Plus High-Flow Catheter Catheter, Intravascular, Diag... Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or ... Class II Cook Inc.
Apr 15, 2016 Shuttle Select Slip-Cath Catheter, Intravascular, Diagnostic The catheters ... Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or ... Class II Cook Inc.
Apr 15, 2016 Aprima Access Nonvascular Introducer Set Accessories, Catheter Intended for... Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or ... Class II Cook Inc.
Apr 15, 2016 Volt Resistance Heated Slipper Black (All sizes) Deep penetrating heat garme... During an FDA inspection it was found that the firm claims unapproved therapy and medical claims ... Class II 2k Innovations Inc.
Apr 15, 2016 Volt Resistance Heated Slipper (All sizes) Deep penetrating heat garment an... During an FDA inspection it was found that the firm claims unapproved therapy and medical claims ... Class II 2k Innovations Inc.
Apr 15, 2016 Ziehm Vision RFD Mot, Mobile C-arm for Mobile Fluoroscopic Imaging Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute time... Class II Ziehm Imaging Inc
Apr 15, 2016 Given Imaging Bravo¿ pH capsule delivery device, 5-pack. In-Vitro Diagnostic... Potential of an allergic reaction in a patient with nickel sensitivity. Class II Covidien 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.