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PRUDENCE BANANA
DKT de México, S.A. de C.V. · Model Condom · UDI-DI 00812420030181
1
510(k) clearances
408
Adverse events (3 deaths)
7
Recalls
77
Facilities
Description
Contraceptive, condom, male Basic male condom, Hevea-latex A Hevea-latex rubber sheath intended to completely cover the penis during coitus to prevent sperm from gaining access to the female reproductive tract and/or prevent the transmission of sexually transmitted infections (STI). It may be textured, flavoured or contain lubricants. This is a single-use device.
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.