Olympus recalls SD-230U-20 electrosurgical snare devices with potential inadequate sterile package seals, risking infections if non-sterile equipment is used. Affected units sold in specific regions and models.
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-230U-20 electrosurgical snare devices due to a small percentage having inadequate sterile package seals. Using these devices could lead to infections if non-sterile equipment is used during medical procedures.
The sterile packages may have partial heat seals, meaning they are not properly sealed. This could allow contaminants to enter the package, increasing the risk of infection if the device is used without proper sterility.
Healthcare professionals using the SD-230U-20 electrosurgical snare devices for endoscopic procedures are most at risk. Patients could develop infections if non-sterile equipment is used during surgery.
Check for the model number SD-230U-20 on the device. The product was sold in specific regions and models including 97V, 98V, 9XV, 9YV, 03V, 04V, 05V, 06V, 07V.
Look for the model number SD-230U-20 on the device to confirm if it is affected.
The recall is due to a small percentage of sterile packages having inadequate package seals, which could lead to infections if non-sterile equipment is used during medical procedures.
Check for the model number SD-230U-20 on the device. The product was sold in specific regions and models including 97V, 98V, 9XV, 9YV, 03V, 04V, 05V, 06V, 07V.
The recall record does not specify a remedy, so there is no action required beyond checking if your device is affected.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0987-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0987-2021 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
