Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI: 04953170420191; Serial Numbes: 2304049 2404551 2404550 2404541 2404537 2404577 2404576 2404574 2404571 2404570 2404569 2404568 2404567 2404566 2404565 2404564 2404563 2404562 2404561 2404560 2404559 2404552 2404547 2404626 2404625 2404624 2404623 2404620 2404619 2404618 2404617 2404616 2404615 2404614 2404613 2404612 2404611 2404610 2404609 2404608 2404607 2404606 2404605 2404604 2404603 2404601 2404599 2404598 2404602 2404600 2404597 2404596 2404595 2404594 2404592 2404591 2404590 2404589 2404588 2404587 2404586 2404584 2404582 2404581 2404580 2404757 2404691 2404686 2404685 2404679 2404678 2404674 2404673 2404672 2404665 2404657 2404655 2404653 2404649 2404647 2404688 2404681 2404727 2404722 2404719 2404710 2404708 2404699 2404643 2404642 2404641 2404640 2404638 2404637 2404636 2404635 2404634 2404633 2404631 2404628 2404621 2404746 2404742 2404741 2404732 2404729 2404723 2404713 2404712 2404709 2404705 2404704 2404703 2404702 2404701 2404700 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- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Olympus Corporation of the Americas
- Reason for Recall:
- It was discovered during device performance testing that the CCD imaging sensors were programmed with the incorrect color correction data and therefore, specifications are not met.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100
Product Codes/Lot Numbers:
UDI-DI: 04953170420191; Serial Numbes: 2304049 2404551 2404550 2404541 2404537 2404577 2404576 2404574 2404571 2404570 2404569 2404568 2404567 2404566 2404565 2404564 2404563 2404562 2404561 2404560 2404559 2404552 2404547 2404626 2404625 2404624 2404623 2404620 2404619 2404618 2404617 2404616 2404615 2404614 2404613 2404612 2404611 2404610 2404609 2404608 2404607 2404606 2404605 2404604 2404603 2404601 2404599 2404598 2404602 2404600 2404597 2404596 2404595 2404594 2404592 2404591 2404590 2404589 2404588 2404587 2404586 2404584 2404582 2404581 2404580 2404757 2404691 2404686 2404685 2404679 2404678 2404674 2404673 2404672 2404665 2404657 2404655 2404653 2404649 2404647 2404688 2404681 2404727 2404722 2404719 2404710 2404708 2404699 2404643 2404642 2404641 2404640 2404638 2404637 2404636 2404635 2404634 2404633 2404631 2404628 2404621 2404746 2404742 2404741 2404732 2404729 2404723 2404713 2404712 2404709 2404705 2404704 2404703 2404702 2404701 2404700 2404698 2404683 2404680 2404675 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Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0181-2025
Related Recalls
Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with an Olympus endoscope to deliver a nylon loop snare.
Olympus Corporation of the Americas
Potential that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally fixed around patient anatomy.
Continued reports of positive cultures and infections have identified updates to the reprocessing materials to minimize potential deviations in TJF duodenoscope reprocessing. Olympus is informing users of these changes, reminding users to closely follow the operation and reprocessing instructions, and providing updated materials to users.
Device kits contained an incorrectly sized 4mm x 4cm urinary tract balloon catheter (BURS0404) instead of the correct 8mm x 15cm nephrostomy tract balloon catheter (BPCN0815). All other components in the kits were correctly included and packaged in the kit.