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Condom
FDA product code HIS · Class 2 · Obstetrics/Gynecology
1,741
Registered devices
408
Adverse events
7
Recalls
401
510(k) clearances
Devices with this code
004® ZERO ZERO FOUR® Aloe Condoms — OKAMOTO USA, INC.ONE — LUNAMAX LLCKeypers — GLOBAL PROTECTION CORP.ONE — GLOBAL PROTECTION CORP.ONE Pleasure — GLOBAL PROTECTION CORP.Atlas Black — GLOBAL PROTECTION CORP.MYONE SAMPLER D11/55J — GLOBAL PROTECTION CORP.DUREX® Air Regular Fit; DUREX® Air — RB Health (us) LLCSpice Up Your Sex Life — SPICE UP ENTERTAINMENT LLCAtlas Studded — GLOBAL PROTECTION CORP.LIFESTYLES — SURETEX LIMITED - BRANCHNuVo Ultra Thin Lubricated condoms — GLOBAL PROTECTION CORP.Custom Condoms — GLOBAL PROTECTION CORP.Crown Lubricated 500 ct Bag — PARADISE MARKETING SERVICES, A CALIFORNIA CORPORATIONmyONE M77/49F — GLOBAL PROTECTION CORP.myONE S17 — GLOBAL PROTECTION CORP.One Flex — GLOBAL PROTECTION CORP.ONE — LUNAMAX LLCTrojan Ultra Thin Armor — CHURCH & DWIGHT CO., INC.Beyond Seven Mega Big Boy 40 ct Bowl — PARADISE MARKETING SERVICES, A CALIFORNIA CORPORATIONmyONE B22 — GLOBAL PROTECTION CORP.HUNK — GLOBAL PROTECTION CORP.CautionWear PPE — CAUTION WEAR CORPONE UltraFeel — GLOBAL PROTECTION CORP.
Recent 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 Benzoca |
| 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 q |
| 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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