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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-1181-2026
Recall Event ID 98234
510(K)NumberK874383 
Product Classification Condom - Product Code HIS
ProductCondoms, labeled as: TROJAN MAGNUM CONDOMS 6/DSP BLACK, TROJAN LUBRICATED CONDOMS 6/DSP LITE BLUE, TROJAN SPERMICIDE CONDOMS 6/DSP DARK BLUE, TROJAN ULTRA THIN CONDOMS 6/DSP GREY, TROJAN RIBBED CONDOMS 6/DSP GOLD/BROWN, TROJAN NONLUBRICATED CONDOMS 6/DSP RED, TROJAN ULTRA HER PLEASURE CONDOMS 6/DSP, TROJAN CONDOMS MAGNUM 48 CT DISP, *BOX TROJAN CONDOMS MAGNUM 50CT .
Code Information TROJAN MAGNUM CONDOMS 6/DSP BLACK, UPC 022600642039; TROJAN LUBRICATED CONDOMS 6/DSP LITE BLUE, UPC 022600930501; TROJAN SPERMICIDE CONDOMS 6/DSP DARK BLUE, UPC 022600931508; TROJAN ULTRA THIN CONDOMS 6/DSP GREY, UPC 022600926207; TROJAN RIBBED CONDOMS 6/DSP GOLD/BROWN, UPC 022600940500; TROJAN NONLUBRICATED CONDOMS 6/DSP RED, UPC 22600920502; TROJAN ULTRA HER PLEASURE CONDOMS 6/DSP, UPC 022600973201; TROJAN CONDOMS MAGNUM 48 CT DISP, UPC 815556020125; *BOX TROJAN CONDOMS MAGNUM 50Ct, UPC none 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 = HIS
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