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U.S. Department of Health and Human Services

Class 2 Device Recall Multiple products

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 Class 2 Device Recall Multiple productssee related information
Date Initiated by FirmDecember 26, 2025
Date PostedJanuary 27, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1182-2026
Recall Event ID 98234
510(K)NumberK081555 
Product Classification Tampon, menstrual, unscented - Product Code HEB
ProductFeminine hygiene products, labeled as: KOTEX FREEDOM MAXI NO WINGS 48CT, ALWAYS THIN LINERS UNSCENTED 12 CT, ALWAYS THIN LINERS SCENTED 12CT, ALWAYS ULT.THIN WINGS REG.12/22CT, ALWAYS ULT.THIN OVER NIGHT WINGS 12/16CT, JULIE MAXI NIGHT W.WINGS 36/10CT, STAY FREE REG. 12/10CT, STAY FREE SUPER 24/6CT, TAMPAX REG. 10CT, TAMPAX SUPER 10CT.
Code Information KOTEX FREEDOM MAXI NO WINGS 48CT, UPC 8935107214222; ALWAYS THIN LINERS UNSCENTED 12 CT, UPC 037000426882; ALWAYS THIN LINERS SCENTED 12CT, UPC 037000426899; ALWAYS ULT.THIN WINGS REG.12/22CT, UPC none; ALWAYS ULT.THIN OVER NIGHT WINGS 12/16CT, UPC none; JULIE MAXI NIGHT W.WINGS 36/10CT, UPC 710865100653; STAY FREE REG. 12/10CT, UPC 078300070320; STAY FREE SUPER 24/6CT, UPC 078300070245; TAMPAX REG. 10CT, UPC 073010214095; TAMPAX SUPER 10CT, UPC 073010314092. All codes purchased from this firm
FEI Number 3004388746
Recalling Firm/
Manufacturer		 GOLD STAR DISTRIBUTION INC
1000 Humboldt Ave N
Minneapolis MN 55411-3964
For Additional Information Contact
612-617-9800
Manufacturer Reason
for Recall		Potential exposure of rodents and rodent activity in the distribution center.
FDA Determined
Cause 2		Storage
ActionGold Start Distribution, Inc. issued a press release on 12/26/2025 to notify the public of their recall of FDA regulated products due to the presence of rodent and avian contamination. The press release explained the risk to health, provided a list of retail outlets to which the products were distributed, and directed those in possession of the affected product to destroy them and verify such destruction by receipt provided to Gold Start at 1000 N. Humboldt Ave, Minneapolis, MN 55411. Refunds will be provided upon request. Customers should contact their physician or health care provider if they have experienced any problems that may be related to using these products. If you have any questions, contact Gold Star at 612-617-9800, 7 days a week, 8:00 am to 5:00 pm, Central Standard Time. The firm followed with a letter to its consignees on 12/30/2025 via email with the same message.
Quantity in Commerceunknown
DistributionUS Nationwide distribution in the states of Minnesota.
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.
510(K) Database510(K)s with Product Code = HEB
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