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SKORE Benzocaine Condoms

TTK HEALTHCARE LIMITED · Model SKORE DUO MAX · UDI-DI 08906007135672

HIS

510(k) clearances

408

Adverse events (3 deaths)

Recalls

Facilities

Description

The SKORE Benzocaine Condoms - SKORE DUO MAX condom is made of natural rubber latex. It is straight walled, bulbous, teat ended, transparent male condoms lubricated with silicone oil with Zeus and Benzocaine cream. It meets the requirements as specified in ISO 4074:2015 – Natural rubber latex male condoms – Requirements and test methods and ASTM D3492:2016– Standard Specification for Rubber Contraceptives (Male Condoms). The SKORE Benzocaine Condoms - SKORE DUO MAX natural rubber latex condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

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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Data 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.