Olympus recalls Crescent Snare surgical device model SD-221L-25 due to potential packaging seal failures that could lead to infections if non-sterile equipment is used during procedures.
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 its Crescent Snare surgical device model SD-221L-25 because some sterile packages have inadequate seals. This could lead to infections if the device is used without proper sterility.
The sterile packaging for the device may have partial heat seals, meaning the seal isn't fully closed. If the packaging isn't properly sealed, the device might not be sterile, increasing the risk of infections during surgery.
Surgical professionals using the Crescent Snare device model SD-221L-25 for digestive tract procedures are most at risk. Patients could develop infections if non-sterile equipment is used during surgery.
Check for the model number SD-221L-25 on the device. The product was sold in specific batches labeled 01K through 9ZK.
Inspect the packaging for partial heat seals that may indicate inadequate sterility.
The recall indicates a small percentage of packages have inadequate seals, so it may not be sterile. Do not use if packaging appears compromised.
Check for the model number SD-221L-25 and batch numbers from 01K through 9ZK on the device packaging.
Inspect the packaging for partial heat seals. If the seal appears compromised, do not use the device and contact Olympus for guidance.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1070-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1070-2021 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.
