Integra LifeSciences Corp.

Integra LifeSciences recalled Codman CerebroFlo EVD Catheters (Product ID 37.550.501, Lot 45322) because testing found endotoxin levels that exceeded safety standards. Endotoxins are bacterial fragments that can trigger harmful immune responses in patients. The affected catheters are used to drain fluid from the brain in hospital settings.

Integra LifeSciences' Cytal Burn Matrix 10x15 cm (Product ID: BMM1015) has been recalled because certain lots tested at higher-than-acceptable endotoxin levels. Endotoxins are bacterial substances that can trigger inflammatory reactions when in contact with body tissues. The FDA identified this issue across 226 units distributed nationwide.

Integra LifeSciences has recalled specific lots of Cytal Burn Matrix (a burn wound dressing) because testing found higher-than-acceptable levels of endotoxin, a bacterial substance that can trigger an immune response. Seven units were distributed across the U.S. No injuries have been reported.

Increased rate of out-of-specification endotoxin results.

Integra LifeSciences' Cytal Wound Matrix 2-Layer (7x10 cm) from specific lot numbers tested higher than safe endotoxin levels. Endotoxins are bacterial substances that can trigger harmful immune responses. No injuries have been reported so far.

Integra LifeSciences' Cytal Wound Matrix 2-Layer 5x5 cm wound dressing (Product ID: WSM0505) has been recalled because some units have higher-than-safe levels of endotoxin, a bacterial substance that can trigger immune reactions. The affected product was distributed nationwide, and no injuries have been reported so far.

CVS Private Label wound care gel (model CVS405406) may have packaging defects that could compromise the sterile barrier protecting the product. This affects specific lot numbers and could allow contamination of the gel used for minor burns, cuts, and abrasions.

Integra LifeSciences has recalled certain lots of MEDIHONEY Calcium Alginate dressing due to potential packaging failures that could compromise the sterile barrier. If the sterile seal is broken, the wound dressing may become contaminated before use. This affects three model numbers distributed worldwide, including to healthcare facilities in the US and internationally.

Integra LifeSciences is recalling specific batches of MediHoney Gel wound dressing because the sterile packaging may fail, potentially allowing contamination. This affects models 31805 and 31815 distributed worldwide. No injuries have been reported.

The 14-gauge Tuohy needle included in certain Codman CereLink ICP Sensor Basic Kits may have corrosion stains on its surface. These kits are used by hospitals and surgical centers for monitoring intracranial pressure during brain procedures. Integra LifeSciences is recalling specific lot numbers distributed worldwide.

Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.

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.

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.

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.