Lelo Hex Lubricated Natural Rubber Latex Condom 12’s
Leloi AB · Model 12s · UDI-DI 08852961029802
1
510(k) clearances
408
Adverse events (3 deaths)
7
Recalls
77
Facilities
Description
The Lelo Hex Lubricated Natural Rubber Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-12-26 | GOLD STAR DISTRIBUTION INC | Potential exposure of rodents and rodent activity in the distribution center. |
| 2022-06-23 | Family Dollar Stores, Llc. | Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022. |
| 2016-11-22 | Reckitt Benckiser LLC | Reckitt Benckiser LLC is recalling Durex Condoms Pleasure Packs due to missing information on the package labeling associated with the active ingredient Benzocaine. |
| 2013-01-14 | Ansell Healthcare Products LLC | Out of an abundance of caution, Ansell is implementing a voluntary recall of the Zero Latex Condom (regular) product. The condom has met or exceeded test and quality standards req |
| 2012-11-05 | Ansell Healthcare Products LLC | One lot of Lifestyles Pleasure Collection Lubricated Condoms is misbranded. Ultra Thin was included rather than Skyn. |
| 2007-09-11 | Global Protection Corp. | Condoms fail the water leak test and package integrity |
| 2002-11-25 | Ansell Healthcare Inc | The condoms are being recalled because information recently available indicates some of these condoms do not meet airburst test standards |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.