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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.