Browse Device Recalls
13 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 13 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 13 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 10, 2026 | Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma... | Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M10... | Class II | Orthofix U.S. LLC |
| Jun 10, 2026 | Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral... | Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M10... | Class II | Orthofix U.S. LLC |
| Jun 10, 2026 | Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral ... | Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M10... | Class II | Orthofix U.S. LLC |
| Jun 10, 2026 | Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilatera... | Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M10... | Class II | Orthofix U.S. LLC |
| Nov 3, 2025 | Brand Name: FORZA" PTC Spacer System Product Name: FORZA" PTC Spacer System ... | Labeling contains claims that are not consistently present. | Class III | Orthofix U.S. LLC |
| Nov 3, 2025 | Brand Name: Pillar" SA PTC Spacer System Product Name: Pillar" SA PTC Spacer... | Labeling contains claims that are not consistently present. | Class III | Orthofix U.S. LLC |
| Nov 3, 2025 | Brand Name: FIREBIRD" SI Fusion System Product Name: FIREBIRD" SI Fusion Sys... | Labeling contains claims that are not consistently present. | Class III | Orthofix U.S. LLC |
| Nov 3, 2025 | Brand Name: CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX" Mini PT... | Labeling contains claims that are not consistently present. | Class III | Orthofix U.S. LLC |
| Nov 3, 2025 | Brand Name: CONSTRUX" Mini Ti Spacer System Product Name: CONSTRUX" Mini Ti ... | Labeling contains claims that are not consistently present. | Class III | Orthofix U.S. LLC |
| Nov 3, 2025 | Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System M... | Labeling contains claims that are not consistently present. | Class III | Orthofix U.S. LLC |
| Sep 19, 2025 | Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation S... | Polyaxial screws do not meet performance standards. | Class II | Orthofix U.S. LLC |
| Jun 24, 2025 | PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-37... | A 37 mm implant width intervertebral body fusion device has a labeling discrepancy with incorrect... | Class II | Orthofix U.S. LLC |
| Feb 20, 2025 | Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device,... | The product is mislabeled with the incorrect anterior height of 10mm, but the laser marking on th... | Class II | Orthofix U.S. 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.