Browse Device Recalls

432 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 432 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 432 FDA device recalls.

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Date	Product	Reason	Class	Firm
Jun 22, 2016	Cardinal Health Mono Rapid Test, Catalog No. B1077-28, a simple test that u...	The Positive Control information referencing human plasma as the antibody material described in t...	Class III	Alere San Diego, Inc.
Feb 29, 2016	Gomco Style Circumcision Clamp Trays is an instrument used to compress the fo...	Two lots of Gomco Style Circumcision Clamp Trays, SSI-0034 and 10-1100 contained a 1.3cm circumci...	Class II	Cardinal Health
Nov 20, 2015	Cardinal Health Tiny Toes; 11470-010T Infant heel warmer	Heel warmers may cause first and second degree burns.	Class II	Philips Electronics North America Corporation
Aug 25, 2015	Ambitex NMD400 Nitrile Exam Gloves size medium. General Hospital and Personal...	Ambitex Nitrile NMD400 Exam Gloves size medium on exam hold were inadvertently placed into commer...	Class II	Cardinal Health
Dec 23, 2014	Lubricated Intubating Stylet 6FR that is inserted into an endotracheal tube t...	A small piece of the stylet sheath has the potential to shear off upon removal of the stylet fro...	Class II	Cardinal Health
Sep 17, 2014	Cardinal Health Prefilled Buffered 10% Formalin. Product Usage:10% NBF is ...	The affected lots could have NBF concentrations that are lower or higher than the desired specifi...	Class I	Richard-Allan Scientific Company
Jul 10, 2013	Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, ...	Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro¿ Fixed Needle I...	Class II	Smiths Medical ASD, Inc.
Jul 10, 2013	Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 1....	Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro¿ Fixed Needle I...	Class II	Smiths Medical ASD, Inc.
Mar 26, 2013	Presource PBDS, General Laparoscopy, Kit, Circulator	Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out...	Class I	Cardinal Health, Medical Products & Services
Mar 26, 2013	Presource PBDS, Beaufort Memorial Hospital, Anesthesia Circuit, Kit	Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out...	Class I	Cardinal Health, Medical Products & Services
Mar 26, 2013	Presource PBDS, Knee Arthroscopy, Kit, Circulator	Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out...	Class I	Cardinal Health, Medical Products & Services
Mar 26, 2013	Presource PBDS, Extremity, Kit, Circulator	Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out...	Class I	Cardinal Health, Medical Products & Services
Mar 26, 2013	Presource PBDS, Total Knee, Kit, Circulator	Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out...	Class I	Cardinal Health, Medical Products & Services
Mar 26, 2013	Presource PBDS, Major Abdominal, Kit, Circulator	Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out...	Class I	Cardinal Health, Medical Products & Services
Mar 26, 2013	Presource PBDS, Total Joint, Kit, Circulator	Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out...	Class I	Cardinal Health, Medical Products & Services
Mar 26, 2013	Presource PBDS, Total Hip, Kit, Circulator	Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out...	Class I	Cardinal Health, Medical Products & Services
Mar 26, 2013	Presource PBDS, Gyn Laparoscopy Kit, Circulator	Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out...	Class I	Cardinal Health, Medical Products & Services
Mar 26, 2013	A) Presource PBDS, Lap Chole, Kit, Clean Up; B) Presource PBDS, Greenwood L...	Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out...	Class I	Cardinal Health, Medical Products & Services
Mar 26, 2013	Presource PBDS, Hand, Kit, Circulator	Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out...	Class I	Cardinal Health, Medical Products & Services
Mar 26, 2013	Presource PBDS, Knee Arthroscopy, Kit, Circulator	Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out...	Class I	Cardinal Health, Medical Products & Services
Mar 26, 2013	Presource PBDS, Shoulder Arthroscopy, Kit, Circulator	Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out...	Class I	Cardinal Health, Medical Products & Services
Mar 26, 2013	Presource PBDS, Shoulder Procedure, Kit, Circulator	Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out...	Class I	Cardinal Health, Medical Products & Services
Jan 21, 2013	Cardinal Health hCG Cassette Rapid Test, Part Number: B1077-22 (Mfg PN: 45821...	Alere San Diego Inc. is recalling the Cardinal Health hCG Cassette Rapid Test because some of the...	Class III	Alere San Diego, Inc.
Dec 18, 2012	Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacit...	Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom...	Class II	Cardinal Health
Dec 18, 2012	Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 60 Count/100 Capac...	Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom...	Class II	Cardinal Health
Dec 18, 2012	Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removab...	Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom...	Class II	Cardinal Health
Dec 18, 2012	Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capaci...	Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom...	Class II	Cardinal Health
Dec 18, 2012	Needle Counters; Sterile; Foam Strip; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capac...	Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom...	Class II	Cardinal Health
Dec 18, 2012	Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/80 Capacity; Sterile; Double ...	Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom...	Class II	Cardinal Health
Dec 18, 2012	Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removabl...	Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom...	Class II	Cardinal Health
Dec 18, 2012	Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacit...	Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom...	Class II	Cardinal Health
Dec 18, 2012	Needle Counters with Blade Disarmer; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capaci...	Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom...	Class II	Cardinal 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.