Olympus recalls SPiN Flex Needles for potential navigation errors during bronchoscopy. This could delay procedures but does not cause injury. Affected models include INS-5410 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 SPiN Flex Needles that may malfunction during bronchoscopy procedures, potentially causing delays in navigation. This does not pose a risk of injury but could lead to procedural delays if not addressed.
The EM sensor tracking system may malfunction during endobronchial procedures, causing the device to report a coil break warning. This could lead to procedural delays but does not cause injury.
Healthcare professionals using SPiN Flex Needles for bronchoscopy procedures are most at risk. Patients undergoing these procedures may experience delays if the instrument malfunctions.
Check for the model number INS-5410 on the instrument. Affected units have lot numbers 06332230201 and below. These needles are intended for clinical use in bronchoscopy procedures.
Look for the model number INS-5410 on the instrument to confirm if it is affected.
No, the recall does not mention any risk of injury. The hazard is limited to potential procedural delays.
Check the model number and lot number. If it matches the affected units, contact Olympus for further instructions.
Yes, affected units have lot numbers 06332230201 and below.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-2268-2023 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-2268-2023 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.
