Olympus recalls SD-210U-25 electrosurgical snare devices with inadequate sterile packaging seals. Patients may get infections if non-sterile equipment is used. Affected units have specific model codes.
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-25 electrosurgical snare devices because some sterile packages have poor seals. This could lead to infections if the equipment isn't properly sterile during surgery.
The sterile packaging on some units has a partial heat seal, meaning the equipment might not be sterile. If non-sterile devices are used during surgery, patients could develop infections.
Surgical teams using the SD-210U-25 electrosurgical snare devices with the listed model codes. Patients at risk if non-sterile equipment is used during procedures.
Check for model codes like 03K, 04K, 05K, 07K, 08K, 09K, 0XK, 92K, 93K, 94K, 95K, 96K, 97K, 98K, 99K, 97V, 98V, 99V, 9XV, 03V, 04V, 05V, 06V, 07V on the packaging. These units were sold with specific model codes.
Inspect the packaging for a partial heat seal that may compromise sterility.
The sterile packaging on some units has a partial heat seal, which could lead to infections if non-sterile equipment is used during surgery.
Model codes include 03K, 04K, 05K, 07K, 08K, 09K, 0XK, 92K, 93K, 94K, 95K, 96K, 97K, 98K, 99K, 97V, 98V, 99V, 9XV, 03V, 04V, 05V, 06V, 07V.
No immediate action is required, but you should check the packaging seal to ensure sterility before use.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0986-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0986-2021 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.
