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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.

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DateProductReasonClassFirm
Apr 20, 2015 ENT Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Hand Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Vein & Vascular Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Standard Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Lipo Pack, Liposuction Expended Pack, and Liposuction Tray - contains Devon L... Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Vaginal Rejuvenation Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Custom Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Pediatric Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Knee Arthro Pack and Knee Arthro Pack II - contains Devon Light Glove Used d... Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Glaucoma Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 General Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Suction Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Blepharoplasty Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Head & Neck Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Surgical Pack and General Surgery Pack - contains Devon Light Glove Used du... Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Skin and Vein Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Vasc Custom Kit - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Endovenous Kit, Endo Pack and Endovenous Laser Kit - contains Devon Light Glo... Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Shoulder Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Phleb Pack and Laser Phleb Pack - contains Devon Light Glove Used during sur... Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Arthroscopy Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Mississippi Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Lima Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 14, 2015 KimVent Turbo-Cleaning Closed Suction System for Adults, 10 F T-Piece (Produc... The internal blue flapper valve of certain KimVent Turbo-Cleaning Closed Suction System for Adult... Class II Halyard Health, Inc
Mar 9, 2015 TS Crown Component 4UR (5/pk), TS Crown Component 5UR (5/pk), TS Crown Compon... The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not t... Class II Specialty Appliance Works, Inc.
Mar 9, 2015 Upper Right Telescope Unibodies (5/pk) and Upper Left Telescope Unibodies (54... The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not t... Class II Specialty Appliance Works, Inc.
Mar 9, 2015 Herbst Universal Nut which is used in a Herbst Appliance A Herbst Appliance ... The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not t... Class II Specialty Appliance Works, Inc.
Mar 9, 2015 LR Telescoping Cantilever Arms (5/pk) and LL Telescoping Cantilever Arms (5/p... The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not t... Class II Specialty Appliance Works, Inc.
Mar 9, 2015 HTM Mechanism Set Set 16, HTH Mechanism Set Size 18, HTH Mechanism Set Size 2... The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not t... Class II Specialty Appliance Works, Inc.
Mar 9, 2015 M-4 Mechanism Set 16 mm and M-4 Mechanism Set 19 mm A Herbst Appliance is us... The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not t... Class II Specialty Appliance Works, Inc.
Mar 9, 2015 MiniScope Hst ROC Crown 15 Patient Kit, and MiniScope Herbst Crown 15 Patient... The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not t... Class II Specialty Appliance Works, Inc.
Mar 9, 2015 TS Herbst Nuts with Backing (10/pk) and TS Herbst Nuts Universal (10/pk) A H... The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not t... Class II Specialty Appliance Works, Inc.
Mar 9, 2015 Specialty MiniScope Mech. Set Size 18, Specialty MiniScope Mech. Set Size 21,... The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not t... Class II Specialty Appliance Works, Inc.
Mar 9, 2015 TS ROC Crown Component 4UR (5/pk), TS ROC Crown Component 5UR (5/pk), TS ROC ... The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not t... Class II Specialty Appliance Works, Inc.
Feb 19, 2015 ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a hu... Outer shipping carton was marked with an incorrect expiry date, however inner product carton was ... Class III Arc Medical Inc
Jan 30, 2015 Bard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber and Bard E... Potential breach of the sterile barrier packaging. Class II C.R. Bard, Inc.
Jan 29, 2015 Elekta Precise Treatment Table It is possible to position the Treatment Table with errors greater than 5mm and no inhibits are d... Class II Elekta, Inc.
Jan 16, 2015 KimVent Wet Pak, Closed Suction System for Adults, Double Swivel Elbow, 14 Fr... Defect: A hole or crack was found which may cause air to leak. Class II Halyard Health
Jan 16, 2015 KimVent Closed Suction System for Adults, Double Swivel Elbow, 14 Fr. Sterile... Defect: A hole or crack was found which may cause air to leak. Class II Halyard Health
Jan 16, 2015 KimVent Closed Suction System for Adults, Double Swivel Elbow, 12 Fr., Steril... Defect: A hole or crack was found which may cause air to leak. Class II Halyard Health
Jan 7, 2015 Precise Digital Accelerator Intended to be used for radiation therapy trea... Elekta has identified a batch of securing bolts that fix the Gantry counter frame weight stack ma... Class II Elekta, Inc.
Dec 19, 2014 Monaco radiation therapy treatment planning system. The Monaco system i... Incorrect CT to ED when using the Monaco Image Statistics Tool. Class II Elekta, Inc.
Dec 19, 2014 Focal Sim radiation therapy treatment planning system Incorrect CT to ED when using the Monaco Image Statistics Tool. Class II Elekta, Inc.
Dec 11, 2014 Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN... The dials in the Autopens are not working - the dial does not stay dialed, but springs right back... Class II Owen Mumford USA, Inc.
Nov 24, 2014 Autoject E1 Fixed needle device, Model Number AJ1310, UPC Code 384701310010 ... The syringe carrier is missing components: a damper and spring. Class II Owen Mumford USA, Inc.
Nov 17, 2014 KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 8.5 mm, Distribut... The cuff inflation line may detach from the endotracheal tube during use. Class I Halyard Health
Nov 17, 2014 KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 7.0 mm, Distribut... The cuff inflation line may detach from the endotracheal tube during use. Class I Halyard Health
Nov 17, 2014 KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 9.0 mm, Distribut... The cuff inflation line may detach from the endotracheal tube during use. Class I Halyard Health
Nov 17, 2014 KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 8.0 mm, Distribut... The cuff inflation line may detach from the endotracheal tube during use. Class I Halyard Health
Nov 17, 2014 KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 7.5 mm, Distribut... The cuff inflation line may detach from the endotracheal tube during use. Class I Halyard Health

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.