Home / Recalls / Olympus Corporation of the Americas / Z-1378-2026

Z-1378-2026 Class II Ongoing

Recalled by Olympus Corporation of the Americas — Center Valley, PA

Recall Details

Product Type
Devices
Report Date
February 25, 2026
Initiation Date
October 22, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3,381 units

Product Description

Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip

Reason for Recall

Firm is initiating a removal due to continued reports of adverse events.

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.

Code Information

Model No. TB-0535PC; UDI: 04953170308659; All Lots.

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  • Z-1352-2026 Class I — Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflatio (January 16, 2026)
  • Z-1354-2026 Class I — Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflat (January 16, 2026)
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  • Z-1292-2026 Class II — Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411 (January 7, 2026)
  • Z-1270-2026 Class II — Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-4 (January 7, 2026)
  • Z-1288-2026 Class II — Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-4 (January 7, 2026)
  • Z-1271-2026 Class II — Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V41 (January 7, 2026)