FDA Enforcement
Class II
Ongoing
MEDLINE UNNA-Z STRETCH ZINC PASTE BANDAGE, REF NONUNNAS40 KOB article #40307010
Recall: Z-1495-2026
·
Reported March 18, 2026
Enforcement
- Recall Number
- Z-1495-2026
- Event ID
- 98328
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- KOB GmbH
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 18, 2026
- Initiation Date
- January 15, 2026
- Classification Date
- March 6, 2026
- Address
- Lauterstr. 50, N/A, Wolfstein, N/A, N/A, Germany
Description
MEDLINE UNNA-Z STRETCH ZINC PASTE BANDAGE, REF NONUNNAS40 KOB article #40307010
Reason
Due to labeling error. Incomplete ingredients listed. Labeling did not include castor oil or calamine.
Code Info
Model/Catalog Number: NONUNNAS40 KOB article #40307010 Customer Code: (01)10888277675438 Lot Numbers: 2520206 2520739
Distribution
U.S.: IL O.U.S.: Not provided as product is manufactured O.U.S.
Quantity
35,328