Olympus recalls SD-240U-15 electrosurgical snare models with potentially inadequate sterile packaging seals. Using non-sterile equipment may cause infections. Affected units sold in specific voltage ranges.
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 SD-240U-15 electrosurgical snare models due to a small percentage having poorly sealed sterile packages. This could lead to infections if non-sterile equipment is used during surgery.
The sterile packages for these surgical tools may have partial heat seals, meaning they are not properly sealed. If the packaging is compromised, the equipment could become contaminated and cause infections during surgery.
Healthcare professionals using the SD-240U-15 electrosurgical snare for digestive tract procedures are most at risk. Patients may develop infections if non-sterile equipment is used during surgery.
Check for the model number SD-240U-15 on the product. Affected units were sold with voltage codes 97V, 98V, 99V, 9YV, 03V, 04V, 05V, 06V, 07V.
Inspect the sterile packaging for partial heat seals that may compromise sterility.
The recall indicates a small percentage of units have inadequate seals, so not all units are affected. Only check the specific model and voltage codes listed.
The recall does not specify a remedy, so check the package seal and contact Olympus if you suspect a compromised seal.
Affected units have model number SD-240U-15 and were sold with voltage codes 97V, 98V, 99V, 9YV, 03V, 04V, 05V, 06V, or 07V.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0989-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0989-2021 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.
