Browse Device Recalls

441 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 441 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 441 FDA device recalls.

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DateProductReasonClassFirm
Apr 21, 2017 Jackson-Pratt Hemaduct Silicone Flat Drain. Sterile, Rx Only. For Single Use... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt Silicone Flat Drain, 10mm, Full Ducts. Sterile, Rx Only. For S... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt PVC Round Drain, 10FR W/Trocar. Sterile, Rx Only. For Single U... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt Silicone Flat Drain, 7mm, 3/4 Ducts. Sterile, Rx Only. For Sin... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Oct 6, 2016 The PAXWIRE Occlusion Balloon System consists of an occlusion catheter, infla... AccessClosure, Inc. (ACI) is voluntarily recalling the PAXWIRE Occlusion Balloon System device ... Class II AccessClosure, Inc., A Cardinal Health Company
Sep 23, 2016 V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, vario... Potential risk associated with corrosion demonstrated on the distraction screw surface. Class II Cardinal Health 200, LLC
Jul 20, 2016 BLUE IMPERVIOUS GOWN WITH THUMBHOOKS, X-LARGE. Non-Sterile, Single Use Only, ... Blue Impervious Gown with thumbhooks, X-large. All lots do not meet design specifications, specif... Class II Cardinal Health
Jul 13, 2016 6F/7F MynxGrip Vascular Closure Device; Product Model MX6721, Product Usa... A total of 70 6F/7F Mynx Grip devices were shipped from a distributor using improper transport/pa... Class II AccessClosure, Inc., A Cardinal Health Company
Jun 27, 2016 The 9025TRU Arterial Blood Gas (ABG) Kit is used to obtain arterial blood sam... Arterial Blood Gas (ABG) Kit- Missing Safety Component. The ABG Kit(s) have been identified as mi... Class II Cardinal Health
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.