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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

2,907 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,907 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 2,907 FDA device recalls in 2015.

Clear
DateProductReasonClassFirm
Jul 10, 2015 PERI GYN PACK 5/CS Used by medical staff to perform surgical procedures ... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 CESAREAN PACK 3/CS Used by medical staff to perform surgical procedures an... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 Gown, surgical 30/CS Used by medical staff to perform surgical procedures... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 LABOR & DELIVERY 4/CS Used by medical staff to perform surgical procedures a... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 LAPAROSCOPY PACK 6/CS Used by medical staff to perform surgical procedures a... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 GAUZE SPONGE 2"X2" 8PLY COTTON 1500PK/CS Used by medical staff to perform s... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 WOUND CLOSURE TRAY I CUSTOMED 50/CS Used by medical staff to perform surgi... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 EXTREMITY ARM PACK 4/CS HOSP. DR. CENTER Used by medical staff to perform s... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 WOUND MANAGEMENT CUSTOMED 20/CS Used by medical staff to perform surgical p... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 SURG GOWN POLYREINF LGE CUSTOM 28/CS Used by medical staff to perform su... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 UROLOGY PACK 4/CS Used by medical staff to perform surgical procedures and... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 MINOR LACERATION TRAY CUSTOMED 50/CS Used by medical staff to perform su... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 PREMIUM ARTHROSCOPY PK CUSTOMED 5/CS Used by medical staff to perform sur... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 GENERAL MINOR PK 5/CS Used by medical staff to perform surgical procedures a... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 MINOR PACK 4/CS Used by medical staff to perform surgical procedures and ... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 LABOR & DELIVERY 4/CS Used by medical staff to perform surgical procedure... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 9, 2015 Perfectum Tuberculin Glass Syringe, Non sterile Catalog numbers 5202, 5205, ... Graduation marks of the syringe are not centered with the numeric position marks on the syringe b... Class II Cadence Inc.
Jul 9, 2015 Micro-Mate Tuberculin Glass Syringe, Non-sterile Catalog numbers 5208, 5209 Graduation marks of the syringe are not centered with the numeric position marks on the syringe b... Class II Cadence Inc.
Jul 9, 2015 HardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container... Hardy Diagnostics is recalling HardyCHROm MRSA due to a report of the potential for breakthrough ... Class II Hardy Diagnostics
Jul 9, 2015 IPS Empress Universal Glaze Spray 270 mL, Product Code/Model/Catalog Number 6... Complaints were received of coarse particles in the glazed surface of IPS e.max Ceram restoration... Class II Ivoclar Vivadent, Inc.
Jul 8, 2015 Medline Electrical Clipper with Charging base The Electrical Surgical Cli... Charging base of surgical clippers overheats and smokes. Class II Medline Industries Inc
Jul 7, 2015 Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 16 Fr, ... Potential breach of the sterile barrier packaging. Class II C.R. Bard, Inc.
Jul 7, 2015 Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 10 Fr, ... Potential breach of the sterile barrier packaging. Class II C.R. Bard, Inc.
Jul 7, 2015 RadiForce RX850, 8MP Color LCD Monitor, Part Code No. 0FTD1958A2, UPC 6905920... EIZO is recalling the RadiForce LCD Monitors could display abnormally while connecting to particu... Class II Eizo Corporation
Jul 7, 2015 Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 14 Fr, ... Potential breach of the sterile barrier packaging. Class II C.R. Bard, Inc.
Jul 7, 2015 RadiForce RX650, 6MP Color LCD Monitor, Part Code No. 0FTD1957A5, 0FTD195B5, ... EIZO is recalling the RadiForce LCD Monitors could display abnormally while connecting to particu... Class II Eizo Corporation
Jul 7, 2015 Magic3 Hydrophilic-coated Female Intermittent Urinary Catheter 14 Fr in the I... Potential breach of the sterile barrier packaging. Class II C.R. Bard, Inc.
Jul 7, 2015 RadiForce GX540, 5MP Monochrome LCD Monitor, Part Code No. 0FTD1826A5, 0FTD18... EIZO is recalling the RadiForce LCD Monitors could display abnormally while connecting to particu... Class II Eizo Corporation
Jul 7, 2015 Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 12 Fr, ... Potential breach of the sterile barrier packaging. Class II C.R. Bard, Inc.
Jul 7, 2015 S4C Occiput Torque Wrench F/Set Screw; used to tighten the S4 Cervical Spinal... A FW103R torque wrench that was improperly reassembled after reprocessing caused a screw to break... Class II Aesculap, Inc.
Jul 6, 2015 Infant Heel Warmer and Infant Gel Warmer, sold under the brand names CooperSu... Product marketed without a 510(k) Class II CooperSurgical, Inc.
Jul 6, 2015 Actuator for angiographic x-ray monitor ceiling suspension system. Actuator ... The actuator assembly became detached and the monitor carriage with a flexvision monitor dropped ... Class II Philips Electronics North America Corporation
Jul 6, 2015 Syngo.plaza; picture archiving and communications system Product Usage: S... Potential issue leading to data loss and patient data mix-up Class II Siemens Medical Solutions USA, Inc
Jul 6, 2015 SENSE Body Coil 1.5T with identification; used in the ACS NT, Intera 1.5T an... Wrong positioning of the coil cables can create unintended resonances via the patient or elevated... Class II Philips Electronics North America Corporation
Jul 3, 2015 nordicICE v 2.3.14 nordicICE is an image processing software package to be... The bug causes BOLD activation maps to be visualized as overlays without taking the coregistrati... Class II NordicNeuroLab AS
Jul 2, 2015 Beacon Tip Torcon NB Advantage Catheter. Angiographic catheter. For use i... Reports of catheter tip splits and or separation. Loss of device function, medical intervention ... Class I Cook Inc.
Jul 2, 2015 Silhouette Lift brochure Silhouette Sutures are for use in midface suspens... Silhouette Lift is recalling the Silhouette Suture brochure because it does not include a comple... Class II Silhouette Lift, Inc.
Jul 2, 2015 Spirit One A-C Powered Hospital Bed Inaccurate scale systems Class II Stryker Medical Division of Stryker Corporation
Jul 2, 2015 Spirit One A-C Powered Hospital Bed Customer complaints associated with faulty brake system Class II Stryker Medical Division of Stryker Corporation
Jul 2, 2015 Slip-Cath Beacon Tip Catheter. Angiographic catheter. For use in angiog... Reports of catheter tip splits and or separation. Loss of device function, medical intervention ... Class I Cook Inc.
Jul 2, 2015 0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Ster... Procedures for the acceptance and control of in-process product have not been adequately establis... Class II MRP, LLC dba AMUSA
Jul 2, 2015 Beacon Tip Royal Flush Plus High-Flow Catheter. Angiographic catheter. ... Reports of catheter tip splits and or separation. Loss of device function, medical intervention ... Class I Cook Inc.
Jul 1, 2015 GEMINI TF Base CT/PET System. The Philips GEMINI PET/CT Imaging Systems ar... Philips has identified four (4) software defects in the Tumor LOC software application that may p... Class II Philips Medical Systems (Cleveland) Inc
Jul 1, 2015 GEMINI LXL CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a ... Philips has identified four (4) software defects in the Tumor LOC software application that may p... Class II Philips Medical Systems (Cleveland) Inc
Jul 1, 2015 GEMINI TF Ready CT/PET System. The Philips GEMINI PET/CT Imaging Systems a... Philips has identified four (4) software defects in the Tumor LOC software application that may p... Class II Philips Medical Systems (Cleveland) Inc
Jul 1, 2015 GEMINI TF 64 Slice CT/PET System. The Philips GEMINI PET/CT Imaging System... Philips has identified four (4) software defects in the Tumor LOC software application that may p... Class II Philips Medical Systems (Cleveland) Inc
Jul 1, 2015 Synthes Tibial Nail Wrap Holds 11 Nails and Synthes Intramedullary Nail Wrap ... The wrap is for single use for nail sterilization but does not have sufficient testing for the de... Class II Synthes (USA) Products LLC
Jul 1, 2015 Synthes Battery Power Line II Oscillator Model 530.710, orthopedic surgical p... Saw head separated from the drive unit or began to come loose. Class II The Anspach Effort, Inc.
Jul 1, 2015 8.5mm Reamer Head for Flexible Intramedullary Nailing System; An orthopedic m... The possibility exists for intraoperative reamer head breakages which could also allow for un-ret... Class II Synthes (USA) Products LLC
Jul 1, 2015 iovera 155 Smart Tip; Catalog numbers:STT0412-10 and STT0412-5 (10 and 5 c... The expiration date on the outer box label and the pouch label for the iovera Smart Tip product i... Class II Myoscience 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.