Browse Device Recalls
2,437 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,437 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 2,437 FDA device recalls in 2013.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 27, 2013 | NEXGEN Complete Knee Solution Monoblock Tibial Drill with stop 10.7 mm. U... | Zimmer is initiating a lot specific recall of the Trabecular Metal" Tibia Stop Drill due to the p... | Class II | Zimmer, Inc. |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, Vented, Metal Finis... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 2mm X 32cm Regular Tip with 1 Hole, Metal F... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip with No Holes, Non-R... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 3mm X 32cm Regular Tip, Vented, Metal Finis... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 2mm X 34cm Regular Tip with No Hole, Metal ... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 10mm X 32cm Regular Tip, vented, Non-Reflec... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, Vented, Metal Finis... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 5mm X 28cm Regular Tip, vented, Non-Reflect... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip , Non-Vented, Metal ... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 5mm X 32cm Aspiration Needle Tip. Suctio... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 5mm X 45cm Regular Tip, Vented, Metal Finis... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 5mm X 45cm Regular Tip, vented, Non-Reflect... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 5mm X 32cm Tip Hydrodissection Tip, Metal F... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: Vented Tip, 5mm X 45cm Non-Reflective with ... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, vented, Non-Reflect... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 2mm X 32cm Regular Tip with 2 Hole, Metal F... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Summit Medical, BL-2006, Myringotomy Lance (Juvenile) Blade, Sterile P, Summi... | Summit Medical has initiated a recall of Myringotomy Lance Blade (Juvenile) because the box cont... | Class II | Summit Medical, Inc. |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 3mm X 32cm Regular Tip, Non-Vented, Metal F... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 10mm X 32cm Pool Suction Tip, Metal Finish.... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 5mm X 32cm Hydrodissection Tip, Non-Reflect... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 5mm X 24cm Regular Tip, Vented, Metal Finis... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | RoboCouch Patient Positioning System Product Usage: is intended for use... | A5 gearboxes responsible for pitch (head up and head down) and roll (patient left and right) moti... | Class II | Accuray Incorporated |
| 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 | GE PET Discovery 610, PET Discovery 710. Intended for head and whole body ... | GE Healthcare has recently become aware of a potential safety issue related with the DMPR functio... | Class II | GE Healthcare, LLC |
| 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 | Varian brand RPM Respiratory Gating System, RPM Gating v1.7.5 with 3D Option,... | Varian has identified an anomaly with the RPM Respiratory Gating System version I.7.5 with 3D Op... | Class II | Varian Medical Systems, Inc. Oncology Systems |
| 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 | MediChoice¿ Rayon Tipped OB/GYN Applicator, 8 inch, Plastic Shaft, Non-Steril... | Owens & Minor Distribution, Inc. is conducting a market withdrawal of MediChoice Applicator OB-GY... | Class II | Owens & Minor Distribution, Inc. |
| Mar 26, 2013 | Edwards Lifesciences Crimpers, Model 9100CR23. The Crimpers are used to ... | Holes in the sterile barrier pouch may be caused by handling of the device during manufacturing o... | Class II | Edwards Lifesciences, LLC |
| 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 | GE, Optima CT660. Intended to produce cross-sectional images of the body b... | GE Healthcare has recently become aware of a potential safety issue related with the DMPR functio... | Class II | GE Healthcare, LLC |
| 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 | Edwards Lifesciences Crimpers, Model 9100CR26. The Crimpers are used to ... | Holes in the sterile barrier pouch may be caused by handling of the device during manufacturing o... | Class II | Edwards Lifesciences, LLC |
| 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 | Oxoid Antimicrobial Susceptibility Test Discs F300 (Nitrofurantoin), Cat. #CT... | Use of affected lots may give false indication of susceptibility to Nitrofurantoin. | Class III | Remel Inc |
| 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 25, 2013 | KWIK-STIK(TM), Quality control kit for culture media, sold as: KWIK-STIK(... | Some of the KWIK-STIK Catalog #01023P Campylobacter coli, Lot# 1023-05-7, contained an inner labe... | Class III | Microbiologics Inc |
| Mar 22, 2013 | ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-7 Taper Ne... | The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 10... | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Mar 22, 2013 | LHB, First Aid Type I Individual Kit, NSN: 6545-00-656-1092, antiseptics, Kit... | The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by t... | Class III | Lighthouse For The Blind |
| Mar 22, 2013 | ORTHOCORD ONE VIOLET AND ONE BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Cata... | The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 10... | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Mar 22, 2013 | STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD ... | The recall was initiated because Advanced Sterilization Products (ASP) has determined that the ST... | Class II | Advanced Sterilization Products |
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.