Olympus recalls SD-210U-10 electrosurgical snare models with inadequate sterile package seals, which could lead to patient infections if non-sterile equipment is used. Affected units include specific model numbers and versions.
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
Olympus is recalling certain SD-210U-10 electrosurgical snare models due to a small percentage having poorly sealed sterile packages. This could lead to infections if the equipment is used without proper sterility.
The sterile packages for these snares may have partial heat seals, meaning they are not properly sealed. If the equipment is used without being sterile, it could lead to infections during medical procedures.
Healthcare professionals using the SD-210U-10 electrosurgical snare with endoscopes for digestive tract procedures are most at risk. Patients using non-sterile equipment could develop infections.
Check for model numbers SD-210U-10 with specific version codes like 01K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 92K, 93K, 95K, 96K, 97K, 98K, 99K, 9XK, 97V, 98V, 99V, 9XV, 03V, 04V, 05V, 06V, 07V, 9YV.
Inspect the sterile package for partial heat seals that may compromise sterility.
The recall is due to a small percentage of sterile packages having inadequate seals, which could lead to infections if non-sterile equipment is used during procedures.
Affected model numbers include SD-210U-10 with specific version codes such as 01K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 92K, 93K, 95K, 96K, 97K, 98K, 99K, 9XK, 97V, 98V, 99V, 9XV, 03V, 04V, 05V, 06V, 07V, 9YV.
Check the model number and version codes on the product label; affected units have specific version codes listed in the recall notice.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0984-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0984-2021 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.
