Olympus recalls 22G EZSHOT aspiration needles with inadequate sterile packaging seals that could lead to infections if used improperly. Affected units include specific model numbers sold in certain regions.
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 a specific model of 22G EZSHOT aspiration needle due to a small percentage having inadequate sterile packaging seals. This could lead to infections if non-sterile equipment is used during medical procedures.
The sterile packaging on some needles has a partial heat seal, meaning the needles might not be properly sterile. If non-sterile needles are used during medical procedures, patients could develop infections.
Healthcare professionals using ultrasound endoscopes for needle procedures in the gastrointestinal tract may be affected. Patients at highest risk are those undergoing procedures with the recalled needles.
Check for model number NA-200H-8022 on the packaging. The needles were sold in specific regions with model numbers like 01K through 9ZK.
Inspect the packaging for a partial heat seal that may indicate inadequate sterility.
The recall states patients may develop infections if non-sterile equipment is used, but does not mention serious injury risks.
Look for model number NA-200H-8022 on the packaging, sold in regions with specific model numbers like 01K through 9ZK.
The recall does not specify a remedy, so contact Olympus directly for guidance.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1069-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1069-2021 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.
