Olympus recalls Crescent Snare model SD-221U-25 due to potential inadequate sterile packaging seals, which could lead to patient infections if non-sterile equipment is used. Affected units were sold in specific batches.
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 Crescent Snare surgical devices (model SD-221U-25) because some sterile packages have weak seals that might let bacteria in. Using these devices could cause infections in patients during surgery.
The sterile packaging for some units has a partial heat seal, meaning it might not be airtight. If the seal fails, bacteria could enter the device, increasing infection risk during surgery.
Surgical teams and hospitals that use the Crescent Snare model SD-221U-25 for digestive tract procedures. Patients at risk are those undergoing surgery with this device if the packaging seal is compromised.
Check for the model number SD-221U-25 on the device. Affected units were sold in specific batches labeled 01K through 9ZK (e.g., 01K, 02K, 03K, etc.).
Inspect the packaging for signs of a partial heat seal, which may indicate inadequate sterility.
The recall is for potential packaging issues, not the device itself. Proper use with intact seals should be safe.
Check for the model number SD-221U-25 and batch labels from 01K through 9ZK (e.g., 01K, 02K, 03K).
Inspect the packaging seal; if it appears compromised, 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-1071-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1071-2021 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.
