FDA (Devices) recall action 97404

Integra LifeSciences Corp. (NeuroSciences) recalled 8 products on 2025-09-10

The FDA (Devices) publishes a recall like this one as 8 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 8 pages.

Products: 8
Announced: 2025-09-10
Critical: 0
Units: 279,655

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–8 of 8

HighFDA (Devices)··2025-09-10
MediHoney surgical adhesive sheets recalled over sterile barrier packaging failures
MediHoney HCS Surgical Adhesive Sheet dressings, catalog number 31738, lot 53824, are recalled after packaging failures were identified that could breach the sterile barrier. 4 units are affected.
Product
Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Surgical Adhesive Sheet Model/Catalog Number: 31738 Product Description: MEDIHONEY¿ HCS SURGICAL ADHESIVE SHEET DRESSINGS with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination with
Category
Distribution
49 states
HighFDA (Devices)··2025-09-10
MediHoney non-adhesive hydrogel dressings recalled over sterile barrier packaging failures
MediHoney Non-Adhesive Hydrogel Sheet Dressings, catalog numbers 31620 and 31640, are recalled after packaging failures were identified that could breach the sterile barrier. 5,374 units are affected.
Product
Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Model/Catalog Number: 31620, 31640 Product Description: MEDIHONEY¿ Non-Adhesive Hydrogel Sheet Dressing with Leptospermum Honey is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydrogel ge
Category
Distribution
49 states
HighFDA (Devices)··2025-09-10
MediHoney paste tubes recalled over packaging failures breaching the sterile barrier
MediHoney Paste tubes, catalog numbers 31515 and 31535, are recalled after packaging failures were identified that could lead to a breach in the sterile barrier. 141,620 units are affected.
Product
Brand Name: MediHoney ¿ Product Name: MediHoney ¿ Tube Model/Catalog Number: 31515 and 31535 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 envir
Category
Distribution
49 states
HighFDA (Devices)··2025-09-10
MediHoney HCS sheet dressings recalled over packaging failures breaching sterility
MediHoney HCS Sheet Dressings, catalog numbers 31612, 31622 and 31644, are recalled after packaging failures were identified that could breach the sterile barrier. 3,583 units are affected.
Product
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 w
Category
Distribution
49 states
HighFDA (Devices)··2025-09-10
MediHoney hydrogel adhesive sheets recalled over sterile barrier packaging failures
MediHoney Hydrogel Adhesive Sheet dressings, catalog numbers 31722 and 31744, are recalled after packaging failures were identified that could breach the sterile barrier. 1,147 units are affected.
Product
Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Adhesive Sheet Model/Catalog Number: 31722, 31744 Product Description: MEDIHONEY¿ HCS ADHESIVE SHEET DRESSING with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydro
Category
Distribution
49 states
HighFDA (Devices)··2025-09-10
MediHoney hydrogel sheet dressings recalled over packaging failures compromising sterility
MediHoney Adhesive Hydrogel Sheet Dressings, catalog numbers 31720 and 31740, are recalled after packaging failures were identified that could breach the sterile barrier. 994 units are affected.
Product
Brand Name: MediHoney¿ Product Name: MediHoney¿ Adhesive Hydrogel Sheet Dressing Model/Catalog Number: 31720, 31740 Product Description: MEDIHONEY¿ Adhesive Hydrogel Sheet Dressing with Leptospermum Honey is a moist wound dressing made of Leptospermum Honey (+15) in combinat
Category
Distribution
49 states
HighFDA (Devices)··2025-09-10
CVS honey wound pads recalled over packaging failures breaching sterile barrier
CVS Honey Pads, catalog numbers 9370613 and 937404, are recalled after packaging failures were identified that could lead to a breach in the sterile barrier. 111,492 units are affected.
Product
Brand Name: CVS Honey Pad Product Name: CVS Honey Pad Model/Catalog Number: 9370613, 937404 Product Description: Infused with natural medical-grade honey Manuka (Leptospermum) honey is a medical-grade honey that is harvested from bees in New Zealand. Researchers have found
Category
Distribution
49 states
HighFDA (Devices)··2025-09-10
MediHoney paste tubes 31505 recalled over packaging failures affecting sterility
MediHoney Paste, catalog number 31505, is recalled after packaging failures were identified that could lead to a breach in the sterile barrier. 15,441 units are affected.
Product
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 con
Category
Distribution
49 states