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

Date	Product	Reason	Class	Firm
Jul 29, 2015	KimVent* Closed Suction System for Adults, 14 F, D-Tip, T-Piece (Product Code...	The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w...	Class II	Halyard Health, Inc
Jul 29, 2015	KimVent* Wet Pak* Closed Suction System for Adults, 14 F, Elbow (Product Code...	The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w...	Class II	Halyard Health, Inc
Jul 29, 2015	KimVent* Closed Suction System for Adults, 14 F, T-Piece, MDI (Product Code 8...	The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w...	Class II	Halyard Health, Inc
Jul 29, 2015	KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, T-Piece (Prod...	The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w...	Class II	Halyard Health, Inc
Jul 29, 2015	KimVent* Wet Pak* Closed Suction System for Adults, 14 F, T-Piece (Product Co...	The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w...	Class II	Halyard Health, Inc
Jul 29, 2015	KimVent* Closed Suction System for Neonates/Pediatrics, 6 F, Elbow (Product C...	The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w...	Class II	Halyard Health, Inc
Jul 29, 2015	KimVent* Wet Pak* Closed Suction System for Pediatrics, 10 F, Y Adapter (Prod...	The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w...	Class II	Halyard Health, Inc
Jul 29, 2015	KimVent* Closed Suction System for Adults, 12 F, Elbow (Product Code 216); Ki...	The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w...	Class II	Halyard Health, Inc
Jul 29, 2015	NovaPlus Trach Care* Closed Suction System for Adults, T-Piece, 14F (Product ...	The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w...	Class II	Halyard Health, Inc
Jul 29, 2015	KimVent* Closed Suction System for Adults, 14 F, DSE (Product Code 2210); Kim...	The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w...	Class II	Halyard Health, Inc
Jul 29, 2015	KimVent* Turbo-Cleaning Closed Suction System for Adults, 10 F, T-Piece (Prod...	The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w...	Class II	Halyard Health, Inc
Jul 29, 2015	NovaPlus Trach Care* Closed Suction System for Adults, Double Swivel Elbow, D...	The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w...	Class II	Halyard Health, Inc
Jul 7, 2015	Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 16 Fr, ...	Potential breach of the sterile barrier packaging.	Class II	C.R. Bard, Inc.
Jul 7, 2015	Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 10 Fr, ...	Potential breach of the sterile barrier packaging.	Class II	C.R. Bard, Inc.
Jul 7, 2015	Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 14 Fr, ...	Potential breach of the sterile barrier packaging.	Class II	C.R. Bard, Inc.
Jul 7, 2015	Magic3 Hydrophilic-coated Female Intermittent Urinary Catheter 14 Fr in the I...	Potential breach of the sterile barrier packaging.	Class II	C.R. Bard, Inc.
Jul 7, 2015	Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 12 Fr, ...	Potential breach of the sterile barrier packaging.	Class II	C.R. Bard, Inc.
Jul 1, 2015	MOSAIQ Oncology Information System MOSAIQ is an oncology information system ...	A problem exists in MOSAIQ resulting in the incorrect field size being sent to the treatment mach...	Class II	Elekta, Inc.
Jun 12, 2015	On-X Prosthetic Heart Valve Product Usage: Indicated for the replacement ...	Incorrect product label. The type of Sewing Ring was mislabeled as being a Standard Sewing Ring ...	Class II	CryoLife, Inc.
Jun 1, 2015	Laksell GammaPlan, a computer based dose planning system specifically designe...	Memory can become corrupted when creating a fused study via drag and drop in Leksell GammaPlan 10.2.	Class II	Elekta, Inc.
May 28, 2015	Surgical Display, Model No. MDSC-2224 (24 inch), Model No. MDSC-2226 (26 inch...	User settings were no longer on the monitor's memory after these systems were powered off and bac...	Class II	Barco Inc.
May 21, 2015	Oncentra Brachy radiation therapy planning software designed to analyze and p...	Incorrect dose calculation for Regions of Interest (ROIs) defined on a secondary image series.	Class II	Elekta, Inc.
Apr 20, 2015	Abdominal Pack and Abdom 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	Eye 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	Orthopedic Split Drape 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	Neurosurgery 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	Bariatric 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	Set Up 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	Gyn 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	Breast Augmentation Pack and Breast Augmentation Expanded Pack - contains Dev...	Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ...	Class II	Stradis Healthcare, LLC.
Apr 20, 2015	Stradi 4500 - 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	Face Lift 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	ACL 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	Laser Evlt Pack and Laser One Leg Evlt - contains Devon Light Glove Used dur...	Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ...	Class II	Stradis Healthcare, LLC.
Apr 20, 2015	Basic 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	Breast 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	Minor Pack and Minor Pack II Pack - contains Devon Light Glove Used during s...	Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ...	Class II	Stradis Healthcare, LLC.
Apr 20, 2015	Tummy Tuck 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	DND 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	Advanced Vein Care - 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	Open 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	Upper Extremity 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	Cysto 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	Face 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	Podiatry 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	Face Lift 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 Pack, Vein Treatment II Pack, Vein Brunswick Pack, Vein No Lidocaine Pac...	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	Lipo/Buttocks 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	Plastic Pack and Plastic HNP Pack - contains Devon Light Glove Used during s...	Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ...	Class II	Stradis Healthcare, LLC.

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.