Olympus recalls SD-210U-15 electrosurgical snare devices with inadequate sterile packaging seals. Patients may get infections if non-sterile equipment is used. Affected units include specific model numbers and batch 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-15 electrosurgical snare devices because some sterile packages have poor seals. This could lead to infections if the equipment is used without proper sterility.
The sterile packaging on some units has a partial heat seal, meaning the equipment might not be sterile. If non-sterile equipment is used during surgery, patients could get infections.
Healthcare professionals using the SD-210U-15 electrosurgical snare with endoscopes for tissue resection are most at risk. Patients using these devices could develop infections if non-sterile equipment is used.
Check for model numbers 05K, 07K, 09K, 92K, 93K, 95K, 96K, 97K, 98K, 99K, 9XK, 9YK, 97V, 98V, 99V, 9XV, 03V, 04V, 05V, 06V, 07V, 9YV on the packaging. The product is sold for use with endoscopes to resect tissue in the digestive tract.
Inspect the packaging for a partial heat seal that may indicate inadequate 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.
Affected model numbers include 05K, 07K, 09K, 92K, 93K, 95K, 96K, 97K, 98K, 99K, 9XK, 9YK, 97V, 98V, 99V, 9XV, 03V, 04V, 05V, 06V, 07V, 9YV.
The recall record does not specify a remedy, so users should check the packaging seal and contact the manufacturer if concerns arise.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0985-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0985-2021 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.
