Z-1184-2026Class II

Pregnancy Test 24Ct

Name: Z-1184-2026 Pregnancy Test 24Ct
Creator: Gold Star Distribution Inc
Published: 2025-12-26
License: https://open.fda.gov/license/

Gold Star Distribution Inc / initiated 2025-12-26 / Open, Classified

FDA source

GOLD STAR DISTRIBUTION INC began a recall of PREGNANCY TEST 24CT on 2025-12-26. FDA classified it as Class II and gives the reason as "Potential exposure of rodents and rodent activity in the distribution center". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1184-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-12-26
Posted: 2026-01-27
Recalling firm: Gold Star Distribution Inc
Product: Pregnancy Test 24Ct
Product code: LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Reason for recall: Potential exposure of rodents and rodent activity in the distribution center.
FDA root cause: Storage
Action: Gold 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.
Distribution: US Nationwide distribution in the states of Minnesota.
Product codes and lots: UPC 048155920200

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1184-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1180-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-04	2026-01-27
Z-1181-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-04	2026-01-27
Z-1182-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-04	2026-01-27
Z-1183-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-04	2026-01-27
Z-1184-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-04	2026-01-27

Product code LCX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)