Olympus recalls B5-2Q balloon catheters with inadequate sterile packaging seals that could lead to infections if used improperly. Affected units have model numbers ending in 01K through 9ZK. Consumers should contact Olympus for details.
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 B5-2Q balloon catheters that may have poor sterile packaging seals. Using these catheters could risk infections for patients during medical procedures.
The catheters' sterile packaging may not seal properly, allowing contaminants to enter. If non-sterile equipment is used during medical procedures, patients could develop infections.
Medical professionals using the B5-2Q catheters for procedures like bile duct injections are most at risk. Patients receiving these catheters during endoscopic procedures could face infections.
Check for model numbers ending in 01K, 03K, 04K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, or 9ZK. These catheters are used with endoscopes to inject contrast media into bile ducts or respiratory organs.
Reach out to Olympus directly for specific instructions on how to handle the recalled catheters.
The recall is due to a small percentage of sterile packages having inadequate seals, which could lead to infections if non-sterile equipment is used.
Model numbers ending in 01K, 03K, 04K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, or 9ZK.
Check the model number on the catheter packaging; affected units have specific suffixes listed in the recall notice.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0961-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0961-2021 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.
