Olympus recalls KD-650L electrosurgical snare models with inadequate sterile package 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 certain KD-650L electrosurgical snare models due to a small percentage having poorly sealed sterile packages. This could lead to infections if the equipment is used without proper sterility.
The sterile packages for these snare models may have partial heat seals, meaning they are not properly sealed. If the equipment is used without being sterile, it could lead to infections in patients during medical procedures.
Healthcare professionals using the KD-650L electrosurgical snare for procedures in the upper digestive tract. Patients at risk if non-sterile equipment is used during surgery.
Check for the model number KD-650L on the product. The affected units were sold in specific batches labeled with codes like 01K through 9ZK.
Inspect the sterile package for signs of partial heat sealing, which may indicate inadequate sterility.
The recall states that a small percentage of units have inadequate package seals, which could lead to infections if non-sterile equipment is used. Not all units are affected.
Check for the model number KD-650L and the batch code on the product, which may be labeled as 01K through 9ZK.
The recall does not specify a remedy, so users should check the package seal and contact Olympus if they have concerns about sterility.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0980-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0980-2021 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.
