FDA Medical Device Recalls (openFDA)
Family Dollar Stores, Llc.: SKYN ORIGINAL NON LATEX CONDOM 12CT, SKU 903409 LS SKYN NON LATEX LUBRICATED CONDOM 3CT, SKU 900794 SKYN ELITE NON LATEX CONDOM 12CT, SKU 903415
- Recall number
- Z-1530-2022
- Recalling firm
- Family Dollar Stores, Llc.
- Product
- SKYN ORIGINAL NON LATEX CONDOM 12CT, SKU 903409 LS SKYN NON LATEX LUBRICATED CONDOM 3CT, SKU 900794 SKYN ELITE NON LATEX CONDOM 12CT, SKU 903415
- Status
- Open, Classified
- Initiated
- 2022-06-23
- Posted
- 2022-08-17
- Terminated
- not on file
- Reason
- Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
- Root cause
- Storage
- Action
- On June 23, 2022, the firm notified affected Family Dollar retail stores via an urgent Pull and Hold notice, effective June 24, 2022. Retail stores were informed that due to a shipping issue, the affected products could not be sold. Stores were instructed to remove affected products from the sales floor and quarantine them. https://www.familydollar.com/file/general/Voluntary_Recall_of_Certain_Over_the_Counter_Products_080522.pdf
- Quantity
- 2877 total
- Distribution
- Product distributed to Family Dollar retail stores in US nationwide.
- Lot, serial or model codes
- All product sold between May 1, 2022 - June 10, 2022.
- 510(k) numbers
- ["K160399"]
- PMA numbers
- not on file
- Product code
- MOL
- Firm FEI
- 1036966
- Firm city
- Chesapeake
- Firm state
- VA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28