Olympus recalls disposable EMR kits with distal attachments containing DEHP that exceeds safe exposure levels per ISO 10993-17:2002. Affected kits include specific model numbers and lot ranges.
The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002
Olympus is recalling certain disposable EMR kits that include a distal attachment. The attachment contains di-2-ethylhexyl phthalate (DEHP), a chemical that exceeds safe exposure levels as defined by international safety standards. This could pose a health risk with prolonged exposure, though the recall does not specify immediate harm.
The distal attachment contains di-2-ethylhexyl phthalate (DEHP), a chemical that exceeds the permissible exposure level set by ISO 10993-17:2002. This means that repeated or prolonged contact with the chemical could pose a health risk, though the recall does not indicate immediate harm or serious injury.
Users of the affected Olympus Disposable EMR kits, particularly medical professionals who handle the attachments regularly. The risk is higher for those with prolonged exposure to the chemical.
Check if your Olympus Disposable EMR Kit includes model numbers K-001, K-002, K-003, K-004, or K-012. Look for specific lot numbers and UDI codes listed in the recall notice.
Identify your Olympus Disposable EMR Kit model and lot numbers to confirm if it is affected by this recall.
The distal attachment contains di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17:2002.
Affected kits include model numbers K-001, K-002, K-003, K-004, and K-012 with specific lot numbers and UDI codes listed in the recall notice.
The recall does not specify an immediate stop-use requirement; however, users should check if their kit is affected and take appropriate action if it is.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-2522-2023 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-2522-2023 from Olympus. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
