Browse Device Recalls

474 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 474 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 474 FDA device recalls.

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DateProductReasonClassFirm
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.