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
Sep 10, 2021 Standard IUD Insertion Kit Firm unable to confirm that the tenaculum devices were produced in accordance with required desig... Class II Stradis Medical, LLC dba Stradis Healthcare
Sep 10, 2021 Endometrial Biopsy Kit Firm unable to confirm that the tenaculum devices were produced in accordance with required desig... Class II Stradis Medical, LLC dba Stradis Healthcare
Sep 10, 2021 Tenaculum, Plastic Firm unable to confirm that the tenaculum devices were produced in accordance with required desig... Class II Stradis Medical, LLC dba Stradis Healthcare
Sep 10, 2021 IUD Insertion Kit Firm unable to confirm that the tenaculum devices were produced in accordance with required desig... Class II Stradis Medical, LLC dba Stradis Healthcare
Sep 10, 2021 IUD Insertion Pack Firm unable to confirm that the tenaculum devices were produced in accordance with required desig... Class II Stradis Medical, LLC dba Stradis Healthcare
Sep 10, 2021 Foundation Kit Firm unable to confirm that the tenaculum devices were produced in accordance with required desig... Class II Stradis Medical, LLC dba Stradis Healthcare
Sep 9, 2021 GENOSYL DS (Delivery System) console, for use as a vasodilator. Manufacturing defect involving reversal of the inlet and outlet gas lines, resulting in delivery ... Class I Vero Biotech, LLC
Aug 5, 2021 Catalog A902416, SureStep" Foley Tray, Silicone, Urine Meter, StatLock" Stabi... There is potential for packaging defects that may impact the sterile barrier. Class II C.R. Bard Inc
Aug 5, 2021 Catalog A300316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainag... There is potential for packaging defects that may impact the sterile barrier. Class II C.R. Bard Inc
Aug 5, 2021 Catalog A399400A, SureStep" Foley Tray, Add-a-Foley, Complete Care", Drainage... There is potential for packaging defects that may impact the sterile barrier. Class II C.R. Bard Inc
Aug 5, 2021 Catalog A319516AM, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing... There is potential for packaging defects that may impact the sterile barrier. Class II C.R. Bard Inc
Aug 5, 2021 Catalog A303416A, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing ... There is potential for packaging defects that may impact the sterile barrier. Class II C.R. Bard Inc
Aug 5, 2021 Catalog A902916, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Sta... There is potential for packaging defects that may impact the sterile barrier. Class II C.R. Bard Inc
Aug 5, 2021 Catalog A300314A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainag... There is potential for packaging defects that may impact the sterile barrier. Class II C.R. Bard Inc
Aug 5, 2021 Catalog A800365, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray There is potential for packaging defects that may impact the sterile barrier. Class II C.R. Bard Inc
Aug 5, 2021 Catalog A800361, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray There is potential for packaging defects that may impact the sterile barrier. Class II C.R. Bard Inc
Aug 5, 2021 Catalog A943216, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Sta... There is potential for packaging defects that may impact the sterile barrier. Class II C.R. Bard Inc
Aug 5, 2021 Catalog A303316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine M... There is potential for packaging defects that may impact the sterile barrier. Class II C.R. Bard Inc
Aug 5, 2021 Catalog A300318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainag... There is potential for packaging defects that may impact the sterile barrier. Class II C.R. Bard Inc
Aug 5, 2021 Catalog A303318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine M... There is potential for packaging defects that may impact the sterile barrier. Class II C.R. Bard Inc
Aug 5, 2021 Catalog A119216M, SureStep" Foley Tray, Lubri-Sil", Urine Meter, Temperature ... There is potential for packaging defects that may impact the sterile barrier. Class II C.R. Bard Inc
Aug 5, 2021 Catalog A800061, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray There is potential for packaging defects that may impact the sterile barrier. Class II C.R. Bard Inc
Aug 5, 2021 Catalog A902616, SureStep" Foley Tray, Bardex" I.C., Lubricath", Urine Meter There is potential for packaging defects that may impact the sterile barrier. Class II C.R. Bard Inc
Aug 5, 2021 Catalog A897514, SureStep" Foley Tray, Silicone, Drainage Bag, StatLock" Stab... There is potential for packaging defects that may impact the sterile barrier. Class II C.R. Bard Inc
Aug 5, 2021 Catalog A942216, SureStep" Foley Tray, Bard LubricathTM, Urine Meter, StatLoc... There is potential for packaging defects that may impact the sterile barrier. Class II C.R. Bard Inc
Aug 5, 2021 Catalog A899916, SureStep" Foley Tray, Lubricath", Drainage Bag, StatLock" St... There is potential for packaging defects that may impact the sterile barrier. Class II C.R. Bard Inc
Aug 5, 2021 Catalog A800360, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray There is potential for packaging defects that may impact the sterile barrier. Class II C.R. Bard Inc
Aug 5, 2021 Catalog A319416AM, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine ... There is potential for packaging defects that may impact the sterile barrier. Class II C.R. Bard Inc
Jun 25, 2021 OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004 The firm identified a precipitation issue which may cause late Ct reactors (a false positive resu... Class II OPTI Medical Systems, Inc
May 26, 2021 Unifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with bui... Mixed Up. Two (2) cases of Unifine Pentips Plus 4mm pen needles have been mixed into a packed con... Class II Owen Mumford USA, Inc.
May 19, 2021 GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860 Reports received of NO measured below desired dose during transition between primary console and ... Class I Vero Biotech, LLC
Apr 20, 2021 Elekta MOSAIC Oncology Information System versions: 2.62, 2.64, 2.70, 2.81, ... Malware attack Class II Elekta, Inc.
Mar 24, 2021 Drop Arm Versamode" The front casters on the 6810A Lumex Drop Arm Versamode are incorrect. Class II Gf Health Products
Feb 18, 2021 ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedi... Customers are being notified of results from a Toxicological Risk Assessment related to potential... Class I Smisson-Cartledge Biomedical, LLC
Feb 18, 2021 ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedi... Customers are being notified of results from a Toxicological Risk Assessment related to potential... Class I Smisson-Cartledge Biomedical, LLC
Feb 18, 2021 ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedi... Customers are being notified of results from a Toxicological Risk Assessment related to potential... Class I Smisson-Cartledge Biomedical, LLC
Feb 15, 2021 Carestream Dental CS 3600 Single Use Normal Tips, Catalog Number 5941216 - Pr... The mirror may become detached and fall from the unit Class II CARESTREAM DENTAL, LLC
Jan 11, 2021 Bard Clean-Cath Intermittent Catheter, 12 French female length (catheter, uro... The device catheter tip was cut off (no tip) and the product packaging was not fully sealed. Class II C.R. Bard, Inc.
Nov 10, 2020 CryoPatch SG Pulmonary Human Cardiac Patch. The patch is cryopreserved in a ... On November 10, 2020, it was discovered that there are post- processing microbial culture test fa... Class II CryoLife, Inc.
Nov 10, 2020 CryoValve SG Pulmonary Human Heart Valve. The valve is cryopreserved in a ti... On November 10, 2020, it was discovered that there are post- processing microbial culture test fa... Class II CryoLife, Inc.
Oct 16, 2020 CORFLO NG/NI Pediatric Neonatal Feeding Tube w/ Anti-IV Connector Detachment of the Male AIV Adaptor from the Y-Connector. Class II Avanos Medical, Inc.
Jul 29, 2020 AVANOS MIC-KEY SF Gastrostomy Feeding Tube Devices had cracked or detached from the feeding tube body Class II Avanos Medical, Inc.
Apr 30, 2020 Elekta Unity, UDI 05060191071321, Image-guided radiation therapy system - Pro... potential risk that Legionella may be present in the Unity machine room, specifically the heat ex... Class II Elekta, Inc.
Apr 15, 2020 SureStep Foley Tray System - Product Usage: Intended for use in the drainage ... There is potential for a white paper-type residue attached to the catheter. Class II C.R. Bard Inc
Mar 16, 2020 CORFLO Percutaneous Endoscopic Gastrostomy (PEG)Kit The CORFLO PEG tube may become blocked at the center of the adapter (occluded) potentially causin... Class II Avanos Medical, Inc.
Jan 13, 2020 The Bard Intra-abdominal Pressure Monitoring Device is composed of a tubing s... Leaks or disconnect near the sampling port of the Intra Abdominal Pressure Monitoring Device whic... Class II C.R. Bard Inc
Dec 18, 2019 Elekta Unity, Image-Guided Radiation Therapy System There have been reports of excessive heating in the MRL Gradient Connection Module. Class II Elekta, Inc.
Dec 11, 2019 Brasseler USA KM169-39-76 Steinmann Pin Single Diamond Smooth, Diameter 2.8 m... 103 packaged and labeled tubes (103 product tubes with 6 pins per tube) of KM168-39-76 Single Dia... Class II Brasseler USA I Lp
Nov 21, 2019 CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product Usage: The FreeS... Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared... Class II Caire, Inc.
Nov 5, 2019 Haylard Closed Suction System for Neonates/Pediatrics, 5 Fr, 1. REF 195, Y-... Avanos Medical has received reports stating that the central lumen of some 5 Fr Neonate/Pediatric... Class II Avanos Medical, 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.