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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

706 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 706 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 706 FDA device recalls in GA.

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DateProductReasonClassFirm
Feb 7, 2018 Halyard Closed Suction System for Adults, Turbo- cleaning¿Closed¿Suction¿Syst... Certain Flex Connectors supplied with Halyard Closed Suction Kits with Flex Connector may become ... Class II Halyard Health, Inc
Jan 22, 2018 Apollo XT Suture Anchor, 5.5 x 15 Product Usage: Apollo XT Suture Anchors... The label on Apollo XT 5.5mm Suture Anchor (part # XTS-5515; lots 2358, 2362, and 2363) indicated... Class II Valeris Medical, LLC
Dec 13, 2017 CORTRAK* 2 Nasogastric/Nasointestinal (NG/NI) Feeding Tubes with Electromagne... The transmitting stylet within CORTRAK* 2 nasogastric/Nasointestinal (NG/NI) Feeding Tubes with A... Class II Halyard Health, Inc
Dec 13, 2017 Bardex Lubricath 3-Way 75cc Continuous Irrigation Foley Catheter (Creevy), 22... Foley Catheter with Incorrect Retainer Cap Print Class II C.R. Bard, Inc.
Dec 1, 2017 ELEKTA Digital Accelerator under the following brand names: Elekta Synergy, S... There is a potential for an uncontrolled extension of iViewGT / XVI detector arms. Class II Elekta, Inc.
Nov 13, 2017 Piranha Screw 4.0 x 12mm, used in Piranha Surgical Plate System The Piranh... Potential incorrect marking and color identification of Piranha screw. Some screws marked as 12 ... Class II Amendia, Inc dba Spinal Elements
Nov 10, 2017 BARD(R) CRITICORE(R) MONITOR, Model: 000002N Series The CritiCore(R) Autom... BMD has identified that some lots of CritiCore(R) monitors may experience failures involving urin... Class II C.R. Bard, Inc.
Nov 10, 2017 CritiCore Automated Urine Output and Temperature Monitor Issues identified with the monitor including urine output measurement errors, temperature measure... Class II C.R. Bard, Inc.
Nov 8, 2017 Medivance(R) ARCTIC SUN(R) ARCTICGEL(TM) Pads: Description, Catalog Number ... Specific lots of ArcticGel Pads have potential issues which may result in the insufficient adhesi... Class II Bard Medical Division
Nov 6, 2017 Unifine Pentips 5mm x 31G pen needles, packaged in 30 ct pen needles. Pro... Device may potentially be compromised by water in end user packaging. Exposure to liquid may comp... Class II Owen Mumford USA, Inc.
Nov 6, 2017 Unifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles. Pro... Device may potentially be compromised by water in end user packaging. Exposure to liquid may comp... Class II Owen Mumford USA, Inc.
Oct 16, 2017 Medivance ArcticGel Small Pad Kit - a box containing a single foil pouch, whi... Hydrogel peeling from the pads. Class II C.R. Bard, Inc.
Oct 6, 2017 Halyard Closed Suction System for Adults, 14 F, T-Piece, MDI, Wet Pak. 12 via... Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptibl... Class II Halyard Health, Inc
Oct 6, 2017 Halyard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, Wet Pak. ... Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptibl... Class II Halyard Health, Inc
Oct 6, 2017 Halyard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI, Wet ... Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptibl... Class II Halyard Health, Inc
Oct 6, 2017 NOVAPLUS* Endotracheal WET PAK* Closed Suction System for Adults with BALLARD... Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptibl... Class II Halyard Health, Inc
Oct 6, 2017 Halyard Closed Suction System for Adults, 14 F, Elbow, Directional Tip, Wet P... Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptibl... Class II Halyard Health, Inc
Oct 6, 2017 Halyard Turbo-Cleaning Closed Suction System for Adults, 14 F, T-Piece, Wet P... Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptibl... Class II Halyard Health, Inc
Oct 6, 2017 Halyard Closed Suction System for Adults with BALLARD Technology WET PAK. 12 ... Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptibl... Class II Halyard Health, Inc
Oct 6, 2017 Halyard Closed Suction System for Adults, 14 F, DSE, Wet Pak. 12 or 6 vials p... Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptibl... Class II Halyard Health, Inc
Oct 6, 2017 Halyard Closed Suction System for Adults, 14 F, T-Piece, Wet Pak. 12 or 6 via... Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptibl... Class II Halyard Health, Inc
Sep 29, 2017 BARD UROS AUTOMATED URINE OUPTUT AND TEMPERATURE MONITOR, MODEL BK10001M ... The possibility exists that use of the Uros Automated Urine Output and Temperature Monitor may le... Class II C.R. Bard, Inc.
Sep 14, 2017 Magic 3 Intermittent Catheters- 12 Male - 30 catheters per box, each catheter... Several instances of a catheter caught in the sterile barrier seal and in some instances cut cath... Class II C.R. Bard, Inc.
Sep 14, 2017 Personal Intermittent Catheters- 16" and 10" lengths - 30 catheters per box, ... Several instances of a catheter caught in the sterile barrier seal and in some instances cut cath... Class II C.R. Bard, Inc.
Sep 14, 2017 HydroSil Gripper Intermittent Catheters- 10" lengths - 30 catheters per box,... Several instances of a catheter caught in the sterile barrier seal and in some instances cut cath... Class II C.R. Bard, Inc.
Jul 28, 2017 Bard Magic 3 Antibacterial Hydrophilic Intermittent Catheter Female, 14 FR (3... Specific lots labeled as an Antibacterial Hydrophilic Intermittent Catheter may lack the hydrophi... Class II C.R. Bard, Inc.
Jul 26, 2017 7x10" Small Utility Positioner with Cover Products may not meet specifications due to possible presence of metal shavings. Class II Molnlycke Health Care, Inc
Jul 26, 2017 9x15" Medium Utility Positioner with Cover Products may not meet specifications due to possible presence of metal shavings. Class II Molnlycke Health Care, Inc
Jul 17, 2017 Covidien Vistec" X-Ray Detectable Sponges, 7317 Vistec" X-Ray Detectable Spon... Medtronic is voluntarily recalling two production lots of its Covidien Vistec" x-ray detectable s... Class II Covidien LP
Jul 7, 2017 Ceres Self-Drilling Variable Screw 4.0 x 12mm The Ceres screws are self-dr... Incorrect direct marking and color identification for the affected lot of Ceres Self-Drilling Var... Class II Amendia, Inc
Jul 7, 2017 Mac Pin Non-Cannulated Screw, 6.5 x 60mm Incorrect labeling for the lot of MAC Pins. Although the pins are laser as 460 mm in length, t... Class II Amendia, Inc
Jun 30, 2017 MOSAIQ Medical Charged-Particle Radiation Therapy System The table shift in the vertical direction was inverted during the use of CMA (Couch Move Assistan... Class II Elekta, Inc.
Jun 21, 2017 MOSAIQ(R) Oncology Information System, Versions 2.50.05 and higher Product... Retention of Outdated Information in an Order Set. In the Care Plan Library, double clicking to ... Class II Elekta, Inc.
Jun 19, 2017 iGUIDE Software 2.2 Product Usage: Control of accurate patient positioni... Incorrect PEC values. Class II Elekta, Inc.
Jun 2, 2017 Arctic Sun ArcticGel Pads - Medium, Product Code 317-07 Label on product box contains the incorrect reference #317-09 while the shelf box label with barc... Class III C.R. Bard, Inc.
Jun 2, 2017 BARD DISPOZ-A-BAG Leg Bag with Flip-Flo Valve with Drain Extension, Extension... Customer complaint of a cut in the side of the leg bag, indicating a potential breach of the prod... Class II C.R. Bard, Inc.
May 23, 2017 Leksell Gamma Knife Icon is a teletherapy device intended for stereotactic ir... If the gantry module is replaced after original installation the configuration settings may be mi... Class II Elekta, Inc.
May 19, 2017 BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J The courtesy labels in 9 boxes of BioGlue were incorrectly labeled as lot 17MJX007 instead of lot... Class II CryoLife, Inc.
Apr 24, 2017 Brennen Skin Graft Mesher. Surgical instrument designed to expand skin gra... Sterilization validation failure. Class II Molnlycke Health Care, Inc
Apr 6, 2017 01.4mm x 457mm (18in) K-Wire, Threaded Blunt, Ref 9080B-18T, Qty: 1 per pack... Mislabeled guide wires - It was discovered that some Guide Wires labeled as stainless steel were ... Class II Amendia, Inc
Mar 31, 2017 Arctic Sun 5000 Temperature Management System, 100-120 V North America and 10... Potential failure of the Arctic Sun 5000 Temperature Management System may occur when the continu... Class II C.R. Bard, Inc.
Mar 9, 2017 SURESTEP Tray, Bardex I.C. Complete Care Drainage Bag, 2000 ml Drainage Bag, ... Misbranded: Product labeled, Not made with natural rubber latex, may in fact contain natural ru... Class II C.R. Bard, Inc.
Mar 2, 2017 Myelotec Video Guided Catheters, REF 2010 3.0 mm OD x 30 Cm Working Length, ... Obstructed/blocked port from defective VGC Access Port Body component. Class II Myelotec, Inc.
Feb 2, 2017 PGCL [poly (glycolide-co-caprolactone)] Absorbable Suture, Manufacturer CP Me... The tensile strength minimum as directed by USP <881> was not met over the length of the product'... Class II CP Medical Inc
Jan 25, 2017 OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible O... Mislabeling. The packaging labeled as left mandible contained a right mandible. Class II Matrix Surgical Holdings, LLC
Jan 10, 2017 Monaco RTP System. Used to make treatment plans for patients with prescrip... Incorrect dose after editing beam number an wedge angle. Class II Elekta, Inc.
Jan 6, 2017 Color contact lenses labeled under the following brands: Diamond, Fierce, Amb... Sterility and Misbranding: Lenses may not be sterile and may be labeled with erroneous lot number... Class II The See Clear Company
Dec 23, 2016 Oncentra External Beam Oncentra Brachy Product Usage: Oncentra is radiati... Cross profile for Varian 60 degree wedge shows "horns." Class II Elekta, Inc.
Dec 21, 2016 Monaco RTP System Product Usage: Used to make treatment plans for patient... Incorrect Enhanced Dynamic Wedge (EDW) or Virtual Wedge (VW) Calculations. Class II Elekta, Inc.
Dec 9, 2016 I-125 CE Marked QuickLink Cartridges; Sterile; Bard Brachysource Radioactive ... Activity and quantity of seeds sent in shipments were incorrect. Class II C.R. Bard, 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.