Olympus recalls certain INJECTOR FORCEMAX UP 2.8MMCH 25G 5MM endoscopic needles due to inadequate sterile packaging seals, which could lead to infections if used improperly.
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 specific endoscopic injection needles because some sterile packages have poor seals. Using these needles without proper sterility could cause infections in patients.
The sterile packaging on some needles has a partial heat seal, meaning the seal might not be strong enough. If the packaging isn't sealed properly, the needles could become contaminated, leading to infections during medical procedures.
Patients using the recalled needles for endoscopic procedures may be at risk of infection if the needles are not sterile. Healthcare providers who use these needles for treating esophageal and gastric varices are most affected.
Check for the model number NM-400L-0525 on the packaging. The product was sold in specific batches labeled 01K, 04K, 05K, 07K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV.
Inspect the packaging for a partial heat seal that may allow contamination.
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.
The affected model is NM-400L-0525, sold in specific batches labeled 01K, 04K, 05K, 07K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV.
Check the packaging for the model number NM-400L-0525 and the batch labels listed above.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0997-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0997-2021 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
