Browse Device Recalls
3,282 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,282 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 3,282 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Mar 25, 2013 | Stryker Orthopaedics Triathlon Femoral Distal Augment- Left; 1 single unit pe... | Stryker Orthopaedics received a report that a label on the external packaging (box) of a Triathal... | Class II | Stryker Howmedica Osteonics Corp. |
| Mar 8, 2013 | Bracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0 Product Usage: Bra... | Ormco Corporation is voluntarily recalling one (1) lot of Bracket Buccal Tubes as a result of a p... | Class II | Ormco/Sybronendo |
| Feb 26, 2013 | Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Mod... | Incorrect size was printed on the outer product packaging. | Class II | Cooper Surgical, Inc. |
| Feb 7, 2013 | Technocut Plus, Sterile Single Use Safety Scalpel, Distributed by: Myco Medi... | Pouch labeling/printing errors and defective packaging resulting in possible compromised sterility. | Class II | Myco Medical Supplies Inc |
| Feb 4, 2013 | Ultradent Products, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, ... | Incorrect packaging of regular set and fast set cartridges. | Class III | Ultradent Products, Inc. |
| Feb 4, 2013 | Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavo... | Incorrect packaging of regular set and fast set cartridges. | Class III | Ultradent Products, Inc. |
| Jan 14, 2013 | BREG Cold Therapy Combination Units containing Sterile Polar Pads. 02356 Rev ... | The recall was initiated because Breg has determined that some Sterile Polar Pads products manufa... | Class II | Breg Inc |
| Jan 14, 2013 | BREG Sterile Polar Pads; 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Mode... | The recall was initiated because Breg has determined that some Sterile Polar Pads products manufa... | Class II | Breg Inc |
| Jan 11, 2013 | NEUROPATH 6Fx90 GUIDING CATH MPC Product Code: GMC60900000 Intended for u... | Sterility of device may be compromised due to lack of packaging integrity | Class II | Codman & Shurtleff, 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 |
| Dec 3, 2012 | SOL SYS 8IN CALCAR SZ12 Packaging: Product is packed within a poly protect... | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... | Class II | DePuy Orthopaedics, Inc. |
| Dec 3, 2012 | SOL SYS L 9IN CALC 2.25/16.5 Packaging: Product is packed within a poly pr... | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... | Class II | DePuy Orthopaedics, Inc. |
| Dec 3, 2012 | SOL SYS F 9 CALC L 13.5MM LG Packaging: Product is packed within a poly pr... | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... | Class II | DePuy Orthopaedics, Inc. |
| Dec 3, 2012 | SOL SYS R 9IN CALC 2.25/22.5 Packaging: Product is packed within a poly pr... | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... | Class II | DePuy Orthopaedics, Inc. |
| Dec 3, 2012 | SOL SYS L 9IN CALC 2.25/18 Packaging: Product is packed within a poly prot... | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... | Class II | DePuy Orthopaedics, Inc. |
| Dec 3, 2012 | SOL SYS L 9IN CALC 2.25/21 Packaging: Product is packed within a poly prot... | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... | Class II | DePuy Orthopaedics, Inc. |
| Dec 3, 2012 | SOL SYS 8IN CALC 1.5/15.0 Packaging: Product is packed within a poly prote... | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... | Class II | DePuy Orthopaedics, Inc. |
| Dec 3, 2012 | SOL SYS 8IN CALC 1.5/16.5 Packaging: Product is packed within a poly prote... | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... | Class II | DePuy Orthopaedics, Inc. |
| Dec 3, 2012 | SOL SYS R 9IN CALC 2.25/15.0 Packaging: Product is packed within a poly pr... | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... | Class II | DePuy Orthopaedics, Inc. |
| Dec 3, 2012 | SOL SYS F 9 CALC L 13.5MM LG Packaging: Product is packed within a poly pr... | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... | Class II | DePuy Orthopaedics, Inc. |
| Dec 3, 2012 | SOL SYS L 9IN CALC 2.25/22.5 Packaging: Product is packed within a poly pr... | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... | Class II | DePuy Orthopaedics, Inc. |
| Dec 3, 2012 | SOL SYS R 9IN CALC 2.25/19.5 Packaging: Product is packed within a poly pr... | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... | Class II | DePuy Orthopaedics, Inc. |
| Dec 3, 2012 | SOL SYS R 9IN CALC 2.25/21 Packaging: Product is packed within a poly prot... | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... | Class II | DePuy Orthopaedics, Inc. |
| Dec 3, 2012 | SOL SYS R 9IN CALC 2.25/18 Packaging: Product is packed within a poly prot... | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... | Class II | DePuy Orthopaedics, Inc. |
| Dec 3, 2012 | SOL SYS F 8 CALC 13.5MM LG Packaging: Product is packed within a poly prot... | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... | Class II | DePuy Orthopaedics, Inc. |
| Dec 3, 2012 | SOL SYS L 9IN CALC 2.25/19.5 Packaging: Product is packed within a poly pr... | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... | Class II | DePuy Orthopaedics, Inc. |
| Dec 3, 2012 | SOL SYS 8IN CALC 1.5/19.5 Packaging: Product is packed within a poly prote... | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... | Class II | DePuy Orthopaedics, Inc. |
| Dec 3, 2012 | SOL SYS R 9IN CALC 2.25/16.5 Packaging: Product is packed within a poly pr... | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... | Class II | DePuy Orthopaedics, Inc. |
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.