Integra LifeSciences Corp. (NeuroSciences): Device Recall

Recall Details

Recall Number

Z-2507-2025

Classification

Class II

Product Type

Device

Recalling Firm

Integra LifeSciences Corp. (NeuroSciences)

Status

Ongoing

Date Initiated

08/05/2025

Location

Princeton, NJ, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

3583 units

Reason for Recall

Packaging failures were identified which could lead to a breach in the sterile barrier.

Product Description

Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Sheet Dressing with Leptospermum Model/Catalog Number: 31612, 31622, 31644 Product Description: MEDIHONEY¿ HCS SHEET DRESSING with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydrogel collodial gelling agent. The gelling agent is contained within the dressing mass. The dressing contains 63%, by weight, Leptospermum Honey. As wound exudate is absorbed, the dressing which has a low pH and high osmolarity forms a gel. This assists in maintaining a moist environment for optimal wound healing, aids in autolytic debridement, and allows for non-traumatic removal. This product is an occlusive dressing, and does require a secondary dressing.

Distribution Pattern

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Canada, Australia, New Zealand, Korea, Guam, Malaysia.

Other Recalls by Integra LifeSciences Corp. (NeuroSciences)

• Class II: Risk 12/12/2025
  Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.
• Class II: Risk 12/12/2025
  Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.
• Class II: Risk 10/03/2025
  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.
• Class I: Dangerous 09/26/2025
  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.
• Class I: Dangerous 09/26/2025
  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.

View all recalls by Integra LifeSciences Corp. (NeuroSciences) →