Distributed in the USA without an approved 510K
Distributed in the USA without an approved 510K
We break every recall down into plain English — this one’s still on our list. Until our write-up is ready, the official FDA hazard and remedy below have the full, accurate details.
We’ve drafted a message you can send Pentax of America Inc to request your refund or repair — edit it as you like.
Subject: Recall Z-1267-2020 — Pentax of America Inc Pentax of America Inc recalls Pentax Video Colonoscope Model: EC34-i10L Hello, I own a Pentax of America Inc recalls Pentax Video Colonoscope Model: EC34-i10L that is covered by recall Z-1267-2020 from Pentax of America Inc. 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.
