Olympus recalls KD-655L electrosurgical snare models with inadequate sterile package seals that could lead to infections if used improperly. Affected units were sold in specific regions and model series.
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 some KD-655L electrosurgical snare devices because their sterile packaging may have poor seals. This could lead to infections if the equipment is not properly sterilized before use.
The sterile packaging for these snare devices may have partial heat seals, meaning the seal isn't fully closed. If the packaging isn't properly sealed, the device could become non-sterile and cause infections during medical procedures.
Healthcare professionals using the KD-655L electrosurgical snare for digestive procedures are most at risk. Patients using the device could face infections if the packaging seal is inadequate.
Check for the model number KD-655L on the device. The affected units were sold in specific regions and model series including 01K through 9ZK.
Inspect the sterile packaging for any signs of partial heat sealing that could compromise sterility.
The recall indicates a small percentage of units have inadequate seals, so it's not safe to use without checking the packaging.
Look for the model number KD-655L and check if it matches the specific model series listed in the recall (01K through 9ZK).
The recall does not specify a remedy, so contact Olympus directly for guidance on handling the device.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0982-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0982-2021 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.
