FOI release
Contaminated Consumer Wet Wipes (Burkholderia stabilis)
Some or all of the information requested was not provided because we didn't hold it.
Case reference FOI2026/00395
Received 10 April 2026
Published 2 June 2026
Request
I am writing following correspondence from the Office for Product Safety and Standards (OPSS), who have stated that MHRA was the lead regulator for the contaminated consumer wet wipes associated with Burkholderia stabilis and linked to fatalities. OPSS has directed all questions of regulatory responsibility, enforcement, recall, and accountability to MHRA. Accordingly, I now request the following information under the Freedom of Information Act 2000 and/or the Environmental Information Regulations 2004 (EIR). If MHRA considers any part of this request to fall under EIR rather than FOIA, please process it under the correct regime without delay. 1. MHRA’s role as “lead regulator” Please provide: • The date on which MHRA formally determined that these wipes were medical products. • Any classification documents, internal assessments, or regulatory determinations relating to these wipes. • Whether MHRA had classified these products as medical devices before the contamination incident. • Any pre‑market or post‑market surveillance undertaken by MHRA relating to these products. • Any concerns previously raised by MHRA about categorisation, labelling, or marketing. If MHRA did not classify these wipes as medical products until after the contamination was discovered, please confirm this explicitly. 2. Regulatory responsibility and potential regulatory gap OPSS has stated that these contaminated wipes were outside their regulatory scope. Please provide: • MHRA’s formal position on whether it understood itself to be the sole regulator responsible for these consumer‑sold wipes. • Any internal MHRA documents assessing regulatory responsibility for these products. • Any MHRA assessments of whether a regulatory gap existed between MHRA and OPSS. • Any internal reviews, lessons‑learned documents, or evaluations of how contaminated wipes reached the market and remained on sale. 3. Investigation into manufacturer, supply chain, and production environment OPSS states that MHRA was responsible for all investigations relating to the manufacturer and supply chain. Please provide: • All MHRA investigation reports relating to the manufacturer, supply chain, or production environment. • Any findings relating to systemic failures in manufacturing or quality control. • Any enforcement notices, sanctions, compliance actions, or regulatory decisions issued by MHRA. • Any correspondence with manufacturers or distributors relating to contamination. If MHRA took no enforcement action, please provide the reasoning and any internal decision records. 4. Product recall decisions OPSS states that manufacturers undertook voluntary recalls and that MHRA did not mandate a recall. Please provide: • Any MHRA assessments of whether a mandatory recall was considered. • Any risk assessments relating to the adequacy of voluntary recalls. • Any MHRA verification that contaminated products were fully removed from the market. • Any internal or external correspondence relating to recall decisions. 5. Coordination with UKHSA and OPSS OPSS states that MHRA and UKHSA led the incident response. Please provide: • MHRA’s role in the UKHSA incident management team. • Any MHRA instructions, guidance, or risk assessments issued to OPSS. • Any MHRA evaluations of cross‑regulator coordination. • Any minutes, notes, or records of meetings involving MHRA, UKHSA, and OPSS. 6. Accountability for regulatory failure OPSS has stated that accountability for regulatory failure is a matter for MHRA. Please provide: • MHRA’s formal position on whether contaminated consumer wipes reached the market under its regulatory oversight. • Any MHRA internal reviews, investigations, or lessons‑learned documents relating to fatalities. • Any planned or completed regulatory reforms arising from this incident. • Any documents assessing MHRA’s own performance or regulatory effectiveness. 7. Documents requested under FOIA/EIR To avoid ambiguity, I request disclosure of: • Classification documents • Risk assessments • Incident reports • Internal briefings • Enforcement notices • Recall assessments • Correspondence between MHRA, OPSS, and UKHSA • Any internal reviews or lessons‑learned documents
Response
See attached
Documents
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