Olympus recalls KD-611L electrosurgical knives with inadequate sterile packaging seals that could lead to infections if used improperly. Affected units were sold in specific 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-611L electrosurgical knives because their sterile packaging may have poor seals. This could lead to infections if the knives are used without proper sterility.
The sterile packaging may have inadequate seals, allowing contaminants to enter. If non-sterile equipment is used during surgery, patients could develop infections.
Healthcare professionals using the KD-611L electrosurgical knives for procedures in the upper digestive tract. Patients at risk if the knives are used without proper sterility.
Look for the model number KD-611L on the knife. The product was sold in specific series: 01K through 9ZK.
Inspect the packaging for signs of inadequate sealing, though the recall does not specify how to identify this.
The recall states patients may develop infections if non-sterile equipment is used, but does not mention serious injury risks.
The affected models are KD-611L with serial numbers in the series 01K through 9ZK.
The recall does not specify a remedy, so no action is required based on the official notice.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0974-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0974-2021 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.
