Browse Device Recalls
14 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 14 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 14 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 19, 2023 | Acu-Loc and Acu-Loc 2 bone plates, screws and accessories for the following R... | Distribution without Pre-Market Clearance | Class II | Acumed LLC |
| Nov 27, 2023 | RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY, LOW PROFILE REF RBL2320 Th... | Due to potential breakage during use. | Class II | Acumed LLC |
| Nov 29, 2022 | Part Number/Part Description: 30-0033-S 30mm Acutrak¿ Fusion Device 6... | Distribution without Pre-Market Clearance | Class II | Acumed LLC |
| Nov 29, 2022 | AcuTwist Acutrak Compression Screws Part Number/Part Description: AI-0010-S... | Distribution without Pre-Market Clearance | Class II | Acumed LLC |
| Nov 29, 2022 | Acutrak 2 Part Number/Part Description: 30-0021 25.0mm Acutrak 2¿ - 5.5 Scr... | Distribution without Pre-Market Clearance | Class II | Acumed LLC |
| Nov 29, 2022 | Dual-Trak Clavicle Screws Part Number/Part Description: 40-0136 3.0mm x 80m... | Distribution without Pre-Market Clearance | Class II | Acumed LLC |
| Mar 9, 2022 | 4.0mm x 12mm Cannulated Screw, Short Thread; Part number 3005-40012 | Cannulated Screws 4.0mm x 10mm and 4.0mm x 12mm may not have sufficient axial pullout strength f... | Class II | Acumed LLC |
| Mar 9, 2022 | 4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010 | Cannulated Screws 4.0mm x 10mm and 4.0mm x 12mm may not have sufficient axial pullout strength f... | Class II | Acumed LLC |
| Apr 20, 2017 | The Acumed Slide-Loc Anatomic Radial Head System is intended for use by surge... | The firm initiates a voluntary removal and discontinue marketing of Slide-Loc Anatomic Radial Hea... | Class II | Acumed LLC |
| Feb 17, 2017 | .045 X 6 ST Guide Wire, Part number 45-0029-S, Sterile 10 pack of WS-1106ST a... | Guide wires sized as .045 X 6 were mis-packaged as .054 X 7 guide wires and those sized as .054 X... | Class II | Acumed LLC |
| Jan 19, 2017 | 6-hole Pubic Symphysis plate (PN 70-0451). The pelvic bone plates for the pe... | The 6-hole Pubic Symphysis plate (PN 70-0451) is specified to be made of Commercially Pure Titani... | Class II | Acumed LLC |
| Dec 5, 2016 | OPT Croutons is a synthetic bone substitute designed for the repair of bony d... | OPT Croutons, part number 65-0210-S, is recalled due to the result of inadequate documentation of... | Class II | Acumed LLC |
| Mar 26, 2014 | The Acumed Tension Band Pin is a fixation pin which is .0625" in diameter and... | Certain lots of Acumed Tension Band Pins are being recalled because the implantable product was m... | Class II | Acumed LLC |
| Mar 26, 2014 | The Osteo-Clage System consists of stainless steel cable/sleeves and compress... | Manufacturing of these devices with a grade of stainless steel that is not within specifications. | Class II | Acumed LLC |
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.