Integra LifeSciences Corp. (NeuroSciences): Device Recall

Recall Details

Recall Number

Z-2505-2025

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

15441 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¿ Paste Model/Catalog Number: 31505 Product Description: MediHoney¿ Paste with Active Leptospermum Honey is a moist dressing made of 100% Active Leptospermum medical grade Honey. The dressing helps maintain a moist environment conducive to wound healing and helps aid and support autolytic debridement. The dressing can be removed without causing trauma to the wound when a primary dressing is used.

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) →