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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 21, 2022 | Restrata, Part Number RWM1-2X2 | Misprinted expiration date on the shelf-box | Class II | Acera Surgical Inc |
| Feb 25, 2022 | Lum Lam Custom Pack - Anesthesia Kit | The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit. | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Feb 25, 2022 | Total Knee Pack - Surgical Kit | The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit. | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Feb 25, 2022 | Anterior Hip Pack - Surgical Kit | The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit. | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Feb 25, 2022 | Surgicare Neuro Pack - Neurological Kit | The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit. | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Feb 25, 2022 | Coryell Memorial Hosp Total, Joint Pack - Surgical Kit | The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit. | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Jan 28, 2022 | Brasseler USA, K-WIRE, Double Trocar Smooth, REF KM172-26-35S | One lot of product was distributed in unsealed packaging | Class II | Brasseler USA, Medical L.L.C. |
| Jan 27, 2022 | BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16C | There is a potential to leak from the catheter where it connects to the drain bag | Class II | C.R. Bard Inc |
| Jan 27, 2022 | BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS14C | There is a potential to leak from the catheter where it connects to the drain bag | Class II | C.R. Bard Inc |
| Dec 22, 2021 | MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr-PULL | The External Retention Bolster contained in the kit may be a larger diameter than the tube. | Class II | Avanos Medical, Inc. |
| Dec 22, 2021 | MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 F... | The External Retention Bolster contained in the kit may be a larger diameter than the tube. | Class II | Avanos Medical, Inc. |
| Nov 22, 2021 | BALLARD* Seal Cassette Replacement MAP - BALLARD* Seal Cassette Replacement f... | Product was distributed with incorrect expiration date. | Class II | Avanos Medical, Inc. |
| Nov 22, 2021 | BALLARD* Multi-Access Port (MAP) Catheter, Double Swivel Y- Adult, 16 French;... | Product was distributed with incorrect expiration date. | Class II | Avanos Medical, Inc. |
| Nov 22, 2021 | BALLARD* Multi-Access Port Catheter, Double Swivel Y Elbow, Adult, 14 French;... | Product was distributed with incorrect expiration date. | Class II | Avanos Medical, Inc. |
| Nov 17, 2021 | DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile | The firm identified a nonconformance in Lot 04882 involving the endcap being manufactured to a lo... | Class II | Medshape, INC. |
| Oct 28, 2021 | Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Numb... | This recall has been initiated to address bulk packed, non-sterile Intravascular Administration S... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Oct 13, 2021 | Oncentra Brachy users using version 4.0 and above with Applicator Modeling li... | Under certain circumstances, there can be a difference between the planned and delivered dose of ... | Class II | Elekta, Inc. |
| Oct 7, 2021 | BioGlue Surgical Adhesive, Model BG3510-5-G | Product is not approved for use in the EU and should not have been distributed in the EU. | Class II | CryoLife, Inc. |
| Sep 27, 2021 | HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL | All lots of the glove may discolor and lose elasticity upon aging, resulting in the inability of ... | Class II | O&M HALYARD INC |
| Sep 17, 2021 | Elekta Medical Linear Accelerator (EMLA), configured as follows: a. Elekta... | There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed ... | Class II | Elekta, Inc. |
| 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. |
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.