Olympus recalls specific endoscopic injectors due to inadequate sterile packaging seals, potentially causing infections. Affected models include NM-400L-0523 with serial numbers 01K-09ZK. 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 certain endoscopic injectors that may have poor sterile packaging seals, increasing infection risk for patients during medical procedures. This recall affects specific model numbers and serial ranges sold in the U.S. since 2010.
The sterile packaging may have inadequate seals, allowing contaminants to enter the product. If the injector is not sterile, it could cause infections during medical procedures like endoscopic injections for varices or digestive tract treatments.
Patients using these injectors for endoscopic procedures may be at risk of infection if non-sterile equipment is used. The recall applies to specific model numbers and serial ranges sold in the U.S. since 2010.
Check for model number NM-400L-0523 with serial numbers in the ranges 01K-09ZK (e.g., 01K, 02K, ..., 9ZK) or 05V-09V (e.g., 05V, 06V, ..., 09V). These injectors were sold in the U.S. since 2010.
Reach out to Olympus directly for specific instructions on how to return or replace the affected product.
The recall states that a small percentage of packages have inadequate seals, so using them without verification could risk infection. Do not use until you confirm the product is safe.
Contact Olympus directly for instructions on returning or replacing the affected product. The recall does not specify a deadline for action.
Check for model number NM-400L-0523 with serial numbers in the ranges 01K-09ZK or 05V-09V. These were sold in the U.S. since 2010.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1011-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1011-2021 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.
