Home › Device types › MOL
Condom, Synthetic
FDA product code MOL · Class 2 · Obstetrics/Gynecology
226
Registered devices
46
Adverse events
5
Recalls
23
510(k) clearances
Devices with this code
LIFESTYLES — SURETEX LIMITED - BRANCHSKYN — SURETEX LIMITED - BRANCHSKYN — SURETEX LIMITED - BRANCHDUREX RealFeel Non-Latex Condom — RB Health (us) LLCSKYN — SURETEX LIMITED - BRANCHSKYN — SURETEX LIMITED - BRANCHSKYN — SURETEX LIMITED - BRANCHSKYN — SURETEX LIMITED - BRANCHSKYN — SURETEX LIMITED - BRANCHSKYN — SURETEX LIMITED - BRANCHSKYN — SURETEX LIMITED - BRANCHSKYN — SURETEX LIMITED - BRANCHSKYN — SURETEX LIMITED - BRANCHSKYN — SURETEX LIMITED - BRANCHLIFESTYLES — SURETEX LIMITED - BRANCHSKYN — SURETEX LIMITED - BRANCHSKYN — SURETEX LIMITED - BRANCHSKYN — SURETEX LIMITED - BRANCHSKYN — SURETEX LIMITED - BRANCHDUREX Avanti Bare- RealFeel Non-Latex Condom — RB Health (us) LLCDurex Intense XL — RB Health (us) LLCSKYN — SURETEX LIMITED - BRANCHSKYN — SURETEX LIMITED - BRANCHSKYN — SURETEX LIMITED - BRANCH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-06-23 | Family Dollar Stores, Llc. | Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022. |
| 2018-12-19 | Reckitt Benckiser LLC | Five batches of the product have failed the specification of 1.0kPa for Burst Pressure. |
| 2018-12-19 | Reckitt Benckiser LLC | Five batches of the product have failed the specification of 1.0kPa for Burst Pressure. |
| 2018-08-06 | Reckitt Benckiser LLC | Product marketed in U.S. does not have sufficient data to ensure that it will meet the internal burst pressure specifications at the end of 5 yrs shelf-life |
| 2018-07-23 | Reckitt Benckiser LLC | The products failed the filed specification of 1.0kPa for Burst Pressure. |
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