Z-1495-2026Class II

MEDLINE UNNA-Z STRETCH ZINC PASTE BANDAGE, REF NONUNNAS40 KOB article #40307010

Name: Z-1495-2026 MEDLINE UNNA-Z STRETCH ZINC PASTE BANDAGE, REF NONUNNAS40 KOB article #40307010
Creator: KOB GmbH
Published: 2026-01-15
License: https://open.fda.gov/license/

KOB GmbH / initiated 2026-01-15 / Open, Classified / root cause: packaging

FDA source

KOB GmbH began a recall of MEDLINE UNNA-Z STRETCH ZINC PASTE BANDAGE, REF NONUNNAS40 KOB article #40307010 on 2026-01-15. FDA classified it as Class II and gives the reason as "Due to labeling error. Incomplete ingredients listed. Labeling did not include castor oil or calamine". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1495-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-01-15
Posted: 2026-03-06
Recalling firm: KOB GmbH
Product: MEDLINE UNNA-Z STRETCH ZINC PASTE BANDAGE, REF NONUNNAS40 KOB article #40307010
Product code: ITG Bandage, Cast
Reason for recall: Due to labeling error. Incomplete ingredients listed. Labeling did not include castor oil or calamine.
Root cause tag: packaging
FDA 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 [email protected]
Quantity in commerce: 35,328
Distribution: U.S.: IL O.U.S.: Not provided as product is manufactured O.U.S.
Product codes and lots: Model/Catalog Number: NONUNNAS40 KOB article #40307010 Customer Code: (01)10888277675438 Lot Numbers: 2520206 2520739

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1495-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1495-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-18	2026-03-06

Product code ITG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)