Olympus recalls MAJ-247 single-use replacement baskets due to potential inadequate packaging seals that could lead to infections if non-sterile equipment is used.
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 single-use replacement baskets for their BML-3Q mechanical lithotripter. The recall is because a small percentage of these baskets have packaging seals that might not be properly sealed, increasing the risk of infection if used improperly.
The baskets have a small percentage with inadequate package seals due to partial heat sealing. This could allow contaminants to enter the sterile packaging, potentially causing infections if the baskets are used without proper sterility.
Healthcare professionals using the MAJ-247 replacement baskets for lithotripter procedures are most at risk. Patients using these baskets could face infections if non-sterile equipment is used.
Check for the model number MAJ-247 on the basket. These baskets were sold with lithotripter models 01K, 02K, 03K, 92K, 93K, 94K, 97K, 98K, 99K, 9XK, 9YK, and 9ZK.
Inspect the basket packaging for a complete seal; if the seal is broken or incomplete, do not use it.
The recall is because a small percentage of these baskets have packaging seals that might not be properly sealed, which could lead to infections if non-sterile equipment is used.
The MAJ-247 replacement baskets are used with lithotripter models 01K, 02K, 03K, 92K, 93K, 94K, 97K, 98K, 99K, 9XK, 9YK, and 9ZK.
Check for the model number MAJ-247 on the basket. These baskets were sold with the specified lithotripter models.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1068-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1068-2021 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.
