Browse Device Recalls
211 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 211 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 211 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 24, 2012 | REF 101-45-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm, DIAMETER 4.5mm***Use... | Exactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices... | Class II | Exactech, Inc. |
| Jan 24, 2012 | REF 101-05-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 3.2mm***Use... | Exactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices... | Class II | Exactech, Inc. |
| Jan 24, 2012 | REF 101-45-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm, DIAMETER 4.5mm***Use... | Exactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices... | Class II | Exactech, Inc. |
| Jan 24, 2012 | REF 101-45-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 4.5mm***Use... | Exactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices... | Class II | Exactech, Inc. |
| Jan 24, 2012 | REF 101-05-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm, DIAMETER 3.2mm***Use... | Exactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices... | Class II | Exactech, Inc. |
| Jan 24, 2012 | REF 101-05-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm, DIAMETER 3.2mm***Use... | Exactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices... | Class II | Exactech, Inc. |
| Oct 17, 2011 | OPTETRAK LOGIC Proximal Tibial Spacer & Screws (2) 2.5 LT BLUE Size 2.5, 8mm*... | Exactech, Inc. of Gainesville, FL recalled their Optetrak Proximal Tibial Spacer after the device... | Class II | Exactech, Inc. |
| Sep 23, 2011 | Product is labeled in part: "***OPTETRAK***TIBIAL TRAY***TRAPEZOID CEMENTED*... | Exactech, Inc. Gainesville, FL is recalling their Optetrak Cemented Trapezoid Tibial Tray, Size 1... | Class II | Exactech, Inc. |
| Sep 23, 2011 | Product is labeled in part: "***OPTETRAK RBK***TIBIAL TRAY***FINNED, CEMENT... | Exactech, Inc. Gainesville, FL is recalling their Optetrak Cemented Trapezoid Tibial Tray, Size 1... | Class II | Exactech, Inc. |
| Aug 19, 2011 | OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED***Match Component Colors 6 ... | Exactech, Inc. of Gainesville, FL is recalling their Optetrak Logic Posterior Stabilized Tibial I... | Class II | Exactech, Inc. |
| Mar 6, 2009 | Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS... | Incorrect thread form on the screw. | Class II | Exactech, 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.