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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

Infrastructure

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

1,506 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,506 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 1,506 FDA device recalls in FL.

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DateProductReasonClassFirm
Sep 6, 2013 PREMIER CARE RECLINER 5570 with Urethane armrests, Multiple side-table option... A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this produ... Class II Winco Mfg., LLC
Aug 29, 2013 BIOMET 3i Endosseous Dental Implant. Due to residual machining fluid identified by discoloration (darker in appearance) on the externa... Class II Biomet 3i, LLC
Aug 26, 2013 Dental Abutment labeled in part: "4555 Riverside Drive Palm Beach Gardens, FL... Reports relating to Biomet 3i's BellaTek Zirconia Dental Abutment fractures were received. Class II Biomet 3i, LLC
Aug 23, 2013 Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The e... One lot of the product was assembled using the Cam Head version of the same prosthesis instead of... Class II Medtronic Xomed, Inc.
Aug 21, 2013 SHOPKO Waterproof Adhesive Pads Antibacterial. Used for covering minor cut... No antibacterial bandages were packed in boxes labeled as antibacterial. Class II ASO, LLC
Aug 12, 2013 Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introd... Due to a labeling error related to the conversion of the inner diameter of the catheter from inch... Class II Cordis Corporation
Jul 26, 2013 Discount Drug Mart Wound Closure Adhesive Surgical Tape Strips 30 strips 1/... This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm ... Class II ASO, LLC
Jul 26, 2013 Leader Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in... This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm ... Class II ASO, LLC
Jul 26, 2013 Duane Reade (DR) Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 ... This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm ... Class II ASO, LLC
Jul 26, 2013 Meijer Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 i... This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm ... Class II ASO, LLC
Jul 26, 2013 Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used ... The device was not appropriately set to mitigate the risk of implant fracture upon rotation insid... Class II Atlas Spine, Inc.
Jul 26, 2013 TopCare Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 i... This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm ... Class II ASO, LLC
Jul 26, 2013 Walgreens ("W" and "Well at Walgreens") Wound Closure Adhesive Surgical Tape... This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm ... Class II ASO, LLC
Jul 26, 2013 HEB Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. S... This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm ... Class II ASO, LLC
Jul 26, 2013 CVS Pharmacy Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. ... This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm ... Class II ASO, LLC
Jul 26, 2013 Premier Value Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in.... This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm ... Class II ASO, LLC
Jul 22, 2013 Contra-Angle Torque Driver Kit For Certain and External Connection Product... During recent revised sterilization validation testing, the included surgical trays did not meet ... Class II Biomet 3i, LLC
Jul 22, 2013 Contra-Angle Torque Driver Kit For Certain Internal Connection Product Usa... During recent revised sterilization validation testing, the included surgical trays did not meet ... Class II Biomet 3i, LLC
Jul 22, 2013 Contra-Angle Torque Driver Kit Product Usage: Molded plastic tray used in... During recent revised sterilization validation testing, the included surgical trays did not meet ... Class II Biomet 3i, LLC
Jul 22, 2013 Navigator Surgical Kit Product Usage: Molded plastic tray used in holding... During recent revised sterilization validation testing, the included surgical trays did not meet ... Class II Biomet 3i, LLC
Jul 22, 2013 Tapered Navigator Certain Surgical Kit Product Usage: Molded plastic tray... During recent revised sterilization validation testing, the included surgical trays did not meet ... Class II Biomet 3i, LLC
Jul 9, 2013 Tray Surgical, ENT (various instrument trays) Used for stot age and transp... The firm will recall and replace the identified instrument trays in the field, with trays that ha... Class II Medtronic Xomed, Inc.
Jul 1, 2013 MRidium 1145 Dose Reduction System (DERS) drug library kit. (This is an opti... The Dose Error Reduction System (DERS) can indicate an incorrect recommended value for the rate v... Class I Iradimed Corporation
Jun 27, 2013 MLS Torpedo Mini-Light Ophthalmic single-port illumination. Sutureless 25-... The product was registered and distributed as a Class I medical device and was subsequently deter... Class II Insight Instruments, Inc.
Jun 10, 2013 Osseotite Parallel Walled Certain 4mm(D)X 15mm (L) Dental Implant Product ... One of the dental implants do not have the internal hex feature. One of the dental implants do n... Class II Biomet 3i, LLC
Jun 10, 2013 Osseotite 2 Certain Prevail 5mm(D)X 4.1mm (P) X X 11.5mm (L) Dental Implant ... One of the dental implants do not have the internal hex feature. One of the dental implants do n... Class II Biomet 3i, LLC
Jun 5, 2013 PANTERA Proximal Humerus Fracture Plate System Potential suture clip breaking during a humerus fixation surgery. Class II Toby Orthopaedics, Inc.
May 30, 2013 ***REF C7120***APEX Arthroscopy Tubing Set. Intended for use for joint irr... Conmed Linvatec received complaints that their products C7120 APEX Arthroscopy Tubing Set, One Co... Class II Linvatec Corp. dba ConMed Linvatec
May 30, 2013 ***REF C7122***QTY 1***APEX Arthroscopy Tubing Set. Intended for use for j... Conmed Linvatec received complaints that their products C7120 APEX Arthroscopy Tubing Set, One Co... Class II Linvatec Corp. dba ConMed Linvatec
May 30, 2013 Exactech Articulated Driver A nonpowered hand-held device intended for me... When torque is applied to the Articulated Driver at the maximum angle, the cross pin may shift ou... Class II Exactech, Inc.
May 23, 2013 Pinook Mini Massager Distributed by www.pinookusa.com. Used to strengthe... Failure to submit a premarket submission and gain approval of a medical device. Class II Pinook-Usa
May 23, 2013 Pinook Micro Massager Distributed by www.pinookusa.com Used to strengthe... Failure to submit a premarket submission and gain approval of a medical device. Class II Pinook-Usa
May 16, 2013 Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Potential to electrostatic discharged (ESD) Class II HeartWare Inc
May 10, 2013 Biomet 3i Dental Implant, Parallel Walled 6mm (D) x 10mm (L) A small number of outer implant boxes may be mislabeled. The inner tray, containing the implant, ... Class II Biomet 3i, LLC
May 10, 2013 Biomet 3i Dental Implant, Non-Platform Switched Parallel Walled Implant 5mm (... A small number of outer implant boxes may be mislabeled. The inner tray, containing the implant, ... Class II Biomet 3i, LLC
May 6, 2013 Anspach MIA 16 (16cm Minimally Invasive Attachment), Rx Only MIA16 attachm... Product did not reach expected sterility assurance level Class II The Anspach Effort, Inc.
May 4, 2013 NIPRO Safe Touch Safety Scalp Vein Set There is a possibility of a crack in the CP luer connector. The position of the crack is at the c... Class II Nipro Medical Corporation
Apr 30, 2013 AsthmaNefrin Starter Kit contains ten (10) AsthmaNefrin vials and one (1) EZ ... Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking ... Class I Nephron Pharmaceuticals Corp.
Apr 30, 2013 EZ Breathe Atomizer Model # EZ-100. For the delivery of liquid medication... Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking ... Class I Nephron Pharmaceuticals Corp.
Apr 30, 2013 EZ Breathe Medication Cup. For the delivery of liquid medications for resp... Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking ... Class I Nephron Pharmaceuticals Corp.
Apr 25, 2013 ***REF MICROMAX***microMax Handpiece***Rx Only***Manufacturer: The Anspach Ef... The firm Anspach Effort of Palm Beach Gardens, FL initiated a voluntary removal of the Pneumatic ... Class II The Anspach Effort, Inc.
Apr 25, 2013 ***REF BLACKMAX-N***Swivel/Angle Motor Assembly***Rx Only***The Anspach Effor... The firm Anspach Effort of Palm Beach Gardens, FL initiated a voluntary removal of the Pneumatic ... Class II The Anspach Effort, Inc.
Apr 25, 2013 ***REF XMAX***XMax Handpiece***Rx Only***Manufacturer: The Anspach Effort, In... The firm Anspach Effort of Palm Beach Gardens, FL initiated a voluntary removal of the Pneumatic ... Class II The Anspach Effort, Inc.
Apr 25, 2013 ***REF IMRI-MOTOR***iMRI Handpiece. Use with iMRI System Only***Rx Only***Man... The firm Anspach Effort of Palm Beach Gardens, FL initiated a voluntary removal of the Pneumatic ... Class II The Anspach Effort, Inc.
Apr 23, 2013 FLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FL... Holes and/or tears can be introduced in the FLEXSTENT¿ inner pouch under some conditions, and to ... Class II Cordis Corporation
Apr 23, 2013 FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: Th... Holes and/or tears can be introduced in the FLEXSTENT¿ inner pouch under some conditions, and to ... Class II Cordis Corporation
Apr 23, 2013 FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: Th... Holes and/or tears can be introduced in the FLEXSTENT¿ inner pouch under some conditions, and to ... Class II Cordis Corporation
Apr 23, 2013 FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: Th... Holes and/or tears can be introduced in the FLEXSTENT¿ inner pouch under some conditions, and to ... Class II Cordis Corporation
Apr 23, 2013 FLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FL... Holes and/or tears can be introduced in the FLEXSTENT¿ inner pouch under some conditions, and to ... Class II Cordis Corporation
Mar 29, 2013 Cordis OPTEASE Retrieval Inferior Vena Cava (IVC) Filter***REF Cat. No.***466... Correction to provide clarification and additional labeling to minimize likelihood on implanting ... Class I Cordis Corporation

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.