Olympus recalls SPiN Drive 19ga histology needles for potential navigation errors during endobronchial procedures. This could cause procedural delays but not serious injury. Affected models include INS-0382 with specific lot numbers.
Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay
Olympus is recalling certain SPiN Drive 19ga histology needles due to electromagnetic sensor tracking issues that may cause navigation errors during endobronchial procedures. This could lead to procedural delays but does not pose a risk of serious injury.
The electromagnetic sensor tracking in these needles can malfunction during endobronchial procedures, causing the system to report a coil break warning. This may lead to procedural delays but does not cause serious injury or immediate harm.
Medical professionals using these needles during endobronchial procedures are most at risk. Patients receiving these procedures may also be affected if the navigation system malfunctions.
Check for the model number INS-0382 on the needle packaging. Lot numbers 04992210324 and below are affected. These needles are intended for use in clinical interventions with CT or endoscopy.
Look for the model number INS-0382 on the needle packaging or label.
Ensure the lot number is 04992210324 or below to confirm it is affected.
The electromagnetic sensor tracking can malfunction during endobronchial procedures, causing the system to report a coil break warning and potentially leading to procedural delays.
No, the recall does not mention any risk of serious injury or death. The potential issue is only procedural delays.
Check for the model number INS-0382 and lot numbers 04992210324 and below on the packaging or label.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-2265-2023 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-2265-2023 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.
