Quality & complianceOfficial

STAXS recalls DOTCH Puru 1 ml syringes after particles found in drawn-up liquid

🇳🇱 IGJ · Thu 29 Oct 2026

The manufacturer has voluntarily withdrawn the affected batches, saying the particles pose an unacceptable risk to the safety and performance of the syringes, according to the Dutch inspectorate IGJ.

STAXS has told users that small particles were found in the liquid after fluid was drawn up with its 1 ml syringes. The Dutch healthcare inspectorate IGJ has published the manufacturer's warning for the DOTCH Puru Syringe, made by STAXS The Netherlands BV. The field safety notice (FSN) is dated 13 October 2026, and the IGJ page carries a warning dated 30 October 2026.

According to the notice, the findings to date suggest this is not an isolated incident within the batch concerned. The deviation may affect several syringes. STAXS says it cannot rule out that affected syringes have already been supplied to customers, so units with loose particles in the fluid path could currently be on the market.

STAXS has assessed the presence of such particles as an unacceptable risk to the safety and performance of the product. As a precaution, it has decided to withdraw the batches concerned from the market voluntarily. The source does not give batch numbers, quantities or any reports of patient harm.

Users are asked to identify the batch or batches immediately, block them from further use and follow the actions set out in the notice. The notice is a two-page PDF. Under the medical device framework, manufacturers must monitor products after they reach the market and act when a risk to users arises, informing users and the inspectorate through a field safety notice.

What it means for your team

  • Check stock, wards and kits for DOTCH Puru 1 ml syringes, and compare batch details against the FSN dated 13 October 2026.
  • Quarantine any matching batches straight away and follow the corrective actions in the notice.
  • Quality teams may want to log the event and review whether syringes from the affected batches were used to prepare or administer injectables.
  • Report any observed particulate contamination through the usual incident and vigilance channels.

Official source: IGJ ↗

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

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