Recall Z-1495-2026 ยท ITG Bandage, Cast
KOB GmbH
MEDLINE UNNA-Z STRETCH ZINC PASTE BANDAGE, REF NONUNNAS40 KOB article #40307010
| Date | Mar 6, 2026 (initiated Jan 15, 2026) |
| Status | Open, Classified |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.