Integra LifeSciences
14 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Integra LifeSciences and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-05-20FDA-DeviceClass IICodman CerebroFlo EVD Catheter recalled for endotoxin contamination
Out-of-specification endotoxin result that did not meet the acceptance criteria.
- 2026-04-22FDA-DeviceClass IIStop using Integra Cytal Burn Matrix
Increased rate of out-of-specification endotoxin results.
- 2026-04-22FDA-DeviceClass IIStop using Cytal Burn Matrix 7x10 cm
Increased rate of out-of-specification endotoxin results.
- 2026-04-22FDA-DeviceClass IICytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.
Increased rate of out-of-specification endotoxin results.
- 2026-04-22FDA-DeviceClass IIStop using Integra Cytal Wound Matrix
Increased rate of out-of-specification endotoxin results.
- 2026-04-22FDA-DeviceClass IIStop using Integra Cytal Wound Matrix
Increased rate of out-of-specification endotoxin results.
- 2026-02-25FDA-DeviceClass IIStop using CVS wound care gel model CVS405406
Potential packaging failures, which could lead to a breach in the sterile barrier.
- 2026-02-25FDA-DeviceClass IIStop using affected MEDIHONEY calcium alginate dressings
Potential packaging failures, which could lead to a breach in the sterile barrier.
- 2026-02-25FDA-DeviceClass IIStop using Integra MediHoney Gel dressing
Potential packaging failures, which could lead to a breach in the sterile barrier.
- 2026-01-14FDA-DeviceClass IICheck Codman CereLink ICP Sensor lot numbers
Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.
- 2026-01-14FDA-DeviceClass IICodman Microsensor Basic Kit. Catalog Number: 626631US. Use of the CODMAN MICROSENSOR Basic Kit is indicated when direct ICP monitoring is required. The kit is indicated for use in both subdural and intraparenchymal pressure monitoring applications only.
Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.
- 2025-11-12FDA-DeviceClass IITruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01;
It was determined that when the navigation system is configured with specific revision combinations of the Multi Instrument Adapter together with the Patient Tracker the system may not meet its specified accuracy for visual verification of device location within the patient s anatomy.
- 2025-11-12FDA-DeviceClass ICODMAN Disposable Perforator 9mm. Cranial Perforator.
Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution.
- 2025-11-12FDA-DeviceClass ICODMAN Disposable Perforator 11mm. Cranial Perforator.
Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution.
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