MEDLINE UNNA-Z STRETCH ZINC PASTE BANDAGE, REF NONUNNAS40 KOB article #40307010
Summary
The FDA issued a Class II for MEDLINE UNNA-Z STRETCH ZINC PASTE BANDAGE, REF NONUNNAS40 KOB article #40307010 by KOB GmbH. Reason: Due to labeling error. Incomplete ingredients listed. Labeling did not include castor oil or calamine..
Details
Source
Device Recall
External ID
Z-1495-2026
Action Date
2026-03-18
Status
Ongoing
Category
device
Product Description
MEDLINE UNNA-Z STRETCH ZINC PASTE BANDAGE, REF NONUNNAS40 KOB article #40307010
Lot/Code Info: Model/Catalog Number: NONUNNAS40 KOB article #40307010 Customer Code: (01)10888277675438 Lot Numbers: 2520206 2520739
Quantity Affected: 35,328
Reason for Recall
Due to labeling error. Incomplete ingredients listed. Labeling did not include castor oil or calamine.
Distribution
U.S.: IL O.U.S.: Not provided as product is manufactured O.U.S.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-01-15
Company
Wolfstein, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 190 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (KOB GmbH) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does KOB GmbH have FDA actions?
This is the only FDA action we have on record for KOB GmbH in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1495-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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