FDA Medical Device Recalls (openFDA)
KOB GmbH: MEDLINE UNNA-Z STRETCH ZINC PASTE BANDAGE, REF NONUNNAS40 KOB article #40307010
- Recall number
- Z-1495-2026
- Recalling firm
- KOB GmbH
- Product
- MEDLINE UNNA-Z STRETCH ZINC PASTE BANDAGE, REF NONUNNAS40 KOB article #40307010
- Status
- Open, Classified
- Initiated
- 2026-01-15
- Posted
- 2026-03-06
- Terminated
- not on file
- Reason
- Due to labeling error. Incomplete ingredients listed. Labeling did not include castor oil or calamine.
- Root cause
- Packaging process control
- Action
- On 01/15/2026, the firm sent a "Medical Device Recall" letter to its distributor informing them that product is being recalled due to a labeling error. The product box/package contained an incomplete ingredient statement. The ingredients castor oil and calamine were missing from the product labeling. On 02/08/2026, the firm sent an updated "URGENT Medical Device Recall" Letter. Customers are instructed to: The products of the concerned lots must be scrapped. They shall not be used, distributed or made available on the market. For questions or assistance - use email simone.viering@kob.de
- Quantity
- 35,328
- Distribution
- U.S.: IL O.U.S.: Not provided as product is manufactured O.U.S.
- Lot, serial or model codes
- Model/Catalog Number: NONUNNAS40 KOB article #40307010 Customer Code: (01)10888277675438 Lot Numbers: 2520206 2520739
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- ITG
- Firm FEI
- 3007858639
- Firm city
- Wolfstein
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28