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Browse Device Recalls

676 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 676 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 676 FDA device recalls in GA.

Clear
DateProductReasonClassFirm
Mar 14, 2013 Precise Treatment Table. To be used as part of radiation therapy treatment... The Column rotation can accidentally be moved to a different position which in the locked position. Class II Elekta, Inc.
Mar 6, 2013 KIMGUARD Container Filters, 7.5in (19cm), Round and 9in. X 9in. (23cm x 23cm)... Some individual container filter units might contain thin areas that may potentially compromise t... Class II Kimberly-Clark Corporation
Feb 11, 2013 Monaco RTP System. Radiation treatment planning. The beam is displayed at the "gantry" angle, but the dose is calculated at the "rotation_start" a... Class II Elekta, Inc.
Jan 18, 2013 Elekta, Apex add-on Micro MLC, collimator for radiation therapy. If the Apex collimator is incorrectly installed on the radiation head, a touchguard inhibit activ... Class II Elekta, Inc.
Dec 19, 2012 Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4... The DICOM tags do not contain sufficient information for XVI to identify the different volumes th... Class II Elekta, Inc.
Sep 18, 2012 MOSAIQ MOSAIQ is an image-enabled electronic medical record system (EMR) u... A patient was seriously mistreated after a user made and saved an inadvertent change to the defin... Class II Elekta, Inc.
Sep 7, 2012 8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The p... The 8 Fr. Bardex All-Silicone Foley Catheter with 3cc balloon had an incorrect inflation volume (... Class II C.R. Bard, Inc., Urological Division
Aug 29, 2012 Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile, Rem... Sterility of the product may be compromised. Class II Remington Medical Inc.
Aug 21, 2012 Oncentra External Beam 4.1. Radiation treatment planning software designed... During the planning process the beam weights can be changed by the customers. When the beam weigh... Class II Elekta, Inc.
Aug 6, 2012 Precise Digital Accelerator Delivery of radiation to defined target volumes There have been a small number of instances in hospitals where the joint between the drive gear a... Class II Elekta, Inc.
Jul 27, 2012 Multileaf Collimator To be used for single or multiple fractions, delivere... Information released with the product Agility did not originally contain information on compatibi... Class II Elekta, Inc.
Jul 5, 2012 ULTRA Fabric Reinforced surgical Gown X-Large Sterile The product is a ste... Package seam of some units may not remain properly sealed to ensure the contents might not be ste... Class II Kimberly-Clark Corporation
Jul 5, 2012 MicroCool Breathable Gown with Towels, X-Larg, X-Long, Sterile The product... Package seam of some units may not remain properly sealed to ensure the contents might not be ste... Class II Kimberly-Clark Corporation
Jul 3, 2012 BP7561 OPTI CCA-TS B-Lac Cassette (25 per box) Cassettes are consumables u... The values reported for PCO2 by BP7561 B-Lac cassettes are biased at high concentrations when use... Class II OPTI Medical Systems, Inc
Jun 29, 2012 Bard Foley procedural trays packaged in breather bags. The product is packag... Incomplete seal on sterile packages of product. Class II C.R. Bard, Inc., Urological Division
Jun 21, 2012 Monaco Product Usage: Planning of radiation therapy Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM ... Class II Elekta, Inc.
Jun 21, 2012 Focal SIM Planning of radiation therapy Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM ... Class II Elekta, Inc.
Apr 27, 2012 Kimberly Clark Patient Warming System - Model 1000 Control Unit. Kimberly... A defect of the "fuse holder" can lead to a Control Unit failure that may cause the device to los... Class II Kimberly-Clark Corporation
Apr 27, 2012 PlasmaJet Open Surgery Handpiece (Part of the PlasmaJet Neutral Plasma Surger... Potential failure in the glued seal between the stem and the tip of the handpiece leading to the ... Class II Plasma Surgical Inc.
May 1, 2011 Cardiogenesis Corporation - Cardiogenesis Transmyocardial Laser. The devic... Following acquisition of Cardiogenesis, we began receiving complaints of sparks, burns, or smoke ... Class II Cardiogenesis Corporation
Dec 31, 2010 ULTRA Fabric Reinforced Surgical Gown, X-Large, Sterile, Test File. The Ki... The impacted product was not intended for commercial distribution to end users. Class III Kimberly-Clark Corporation
Sep 16, 2010 Kimberly-Clark Patient Warming System - Model 1000 Control Unit The produc... Error 85 alarm on the Model 1000 Control Unit was occasionally triggered inappropriately. Class II Kimberly-Clark Corporation
Jun 22, 2010 Kimberly-Clark MIC PEG Kit - Pull Type The Kimberly-Clark MIC PEG Kits - P... The placement guidewire diameter is too large and does not pass-through the introducer needle dur... Class II Kimberly-Clark Corporation
Jun 22, 2010 Kimberly-Clark MIC Safety PEG Kit - Pull Type The Kimberly-Clark MIC PEG K... The placement guidewire diameter is too large and does not pass-through the introducer needle dur... Class II Kimberly-Clark Corporation
Sep 17, 2009 MicroCool Breathable Impervious Gown with Secure Fit Surgical, (Large and X-L... Complaints were received of gowns pilling or balling, linting and abrades, blood strikethrough an... Class II Kimberly-Clark Corporation
Sep 17, 2009 MicroCool Breathable Impervious Surgical Gown, (Large and X-Large), Sterile, ... Complaints were received of gowns pilling or balling, linting and abrades, blood strikethrough an... Class II Kimberly-Clark 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.