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U.S. Department of Health and Human Services

Class 2 Device Recall UNNAZStretch

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 Class 2 Device Recall UNNAZStretchsee related information
Date Initiated by FirmJanuary 15, 2026
Date PostedMarch 06, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1495-2026
Recall Event ID 98328
Product Classification Bandage, cast - Product Code ITG
ProductMEDLINE UNNA-Z STRETCH ZINC PASTE BANDAGE, REF NONUNNAS40 KOB article #40307010
Code Information Model/Catalog Number: NONUNNAS40 KOB article #40307010 Customer Code: (01)10888277675438 Lot Numbers: 2520206 2520739
FEI Number 3007858639
Recalling Firm/
Manufacturer		 KOB GmbH
Lauterstr. 50
Wolfstein Germany
Manufacturer Reason
for Recall		Due to labeling error. Incomplete ingredients listed. Labeling did not include castor oil or calamine.
FDA Determined
Cause 2		Packaging process control
ActionOn 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 in Commerce35,328
DistributionU.S.: IL O.U.S.: Not provided as product is manufactured O.U.S.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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