Browse Device Recalls
11 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 11 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 11 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 19, 2018 | Instructions for Use and Surgical Cleaning and Sterilization Protocol for: ... | Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised... | Class II | Trilliant Surgical, LLC |
| Mar 27, 2018 | Cannulated Driver Handle, Catalog #: 210-00-003, Rx Only, Non Sterile | Firm is voluntarily recalling cannulated driver handles (210-00-003 and 210-00-004) that may demo... | Class II | Trilliant Surgical Ltd. |
| Mar 27, 2018 | Ratcheting Cannulated Driver Handle, Catalog #: 210-00-004, Rx Only, Non Sterile | Firm is voluntarily recalling cannulated driver handles (210-00-003 and 210-00-004) that may demo... | Class II | Trilliant Surgical Ltd. |
| Dec 8, 2016 | Tiger Screw Sterilization Tray Base Assembly Model 210-00-001 Revision N, O ... | Four lots of Tiger Screw Sterilization Tray Base Assemblies were released to the field with a pri... | Class II | Trilliant Surgical Ltd. |
| Sep 2, 2016 | Model 208-70-110, Long Thread Tiger Large Cannulated Headless Screw, 7 x 110 ... | Screws were identified as having the incorrect part number and lot number marked upon them. The ... | Class II | Trilliant Surgical Ltd. |
| Aug 6, 2015 | 7 Hole VL Gridlock Fibula Plate, Part # 300-60-001 NON-STERILE SINGLE USE ONL... | The affected parts subject to the recall are out of specification, resulting in in the loss of th... | Class II | Trilliant Surgical Ltd. |
| Jul 31, 2015 | 2.4, 3.0, and 4.0 mm Gridlock Screw Driver Bit, Model Number 310-30-003, Lot ... | Gridlock screw driver bits for the Gridlock Plating System were identified to be out of specifica... | Class II | Trilliant Surgical Ltd. |
| Jul 20, 2015 | 3.0/4.0 Cannulated Drill Bit; a component of the Tiger Cannulated Screw Syste... | The cannulation of the 3.0/4.0 Cannulated Drill Bit inner diamter is too small to allow for the g... | Class II | Trilliant Surgical Ltd. |
| Jul 20, 2015 | 2.0/2.4 Cannulated Screw Countersink Part # 210-24-002 NON-STERILE and 3.0/4.... | The cutting efficiency of the Countersinks was out of specification. | Class II | Trilliant Surgical Ltd. |
| Jul 20, 2015 | Tiger Cannulated Tray Lid Part # 210-00-001-1 NON-STERILE; Combined Tiger/Hea... | Sterilization tray lids for the Tiger and Tiger Headless Cannulated Screw Systems were reported t... | Class II | Trilliant Surgical Ltd. |
| Jul 20, 2015 | Concave Reamer Head, 16 mm; Concave Reamer Head, 18 mm; Concave Reamer Head, ... | The cannulation of the Concave and Convex Reamer Heads may be too small to allow the Guide Pin to... | Class II | Trilliant Surgical Ltd. |
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.