Quality & complianceOfficial

SÚKL orders precautionary withdrawal of five Primeros and You Me condom batches

🇨🇿 SÚKL · Fri 06 Nov 2026

The Czech authority says selected lots of the two condom brands are being pulled from the market as a precaution, and advises consumers not to use them.

The Czech State Institute for Drug Control (SÚKL) has announced a precautionary withdrawal from the Czech market of selected batches of Primeros and You Me condoms. The notice, published on 6 November 2026 by its medical devices regulation section, says the aim is to protect consumers and ensure the safe use of the devices.

Five products are listed. The Primeros products are Innocent (lot 5974), Innocent Ultra Thin (lot 6207) and Softglide Ultra Thin (lot 6208). The You Me products are Darling (lot 5981) and Condom Darling CEE Ultra Thin (lot 6rri214, as written in the notice). Expiry dates run from 29 August 2030 to 29 December 2030. The notice marks the manufacturing and expiry dates with an asterisk, but the accompanying footnote is not included in the text available.

SÚKL does not identify a specific defect. It describes the withdrawal as a proposed precautionary measure within its monitoring of the safety of medical devices on the market. The notice gives no details of any complaints, test results or incidents.

Consumers are told to compare the lot number on the pack with the list and not to use products from the affected batches. They should contact the seller or importer about a free exchange or other resolution, and follow the importer's current instructions on returns. Information is available on primeroscondom.cz for Primeros and youmecondom.com for You Me. SÚKL stresses that the advice covers only the listed lots, not all products under either brand.

What it means for your team

  • Check distribution and stock records for the five listed lots, and quarantine any affected stock held in the Czech Republic.
  • The notice gives no reason beyond 'precautionary', so manufacturers, importers and authorised representatives should ask the importer or SÚKL for details of the underlying concern.
  • Check the lot numbers and dates against packaging and the full notice before acting. The You Me lot code 6rri214 is unusual in format, and the notice's date footnote is not reproduced.
  • Make sure return and exchange arrangements follow the importer's current instructions, and keep customer and vigilance communications consistent with them.

Official source: SÚKL ↗

Article written by VigiEye from the official source (SÚKL). AI-assisted; check the source before acting.

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