Home / Recalls / Olympus Corporation of the Americas / Z-1372-2026

Z-1372-2026 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
88,268 units

Product Description

Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S

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-0535FCS; UDI: 04953170383564, 04953170383557, 04953170409677, 04953170383540; All Lots.

Other recalls by Olympus Corporation of the Americas

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  • Z-1488-2026 Class II — Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box (January 29, 2026)
  • 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)
  • Z-1353-2026 Class I — Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insuffla (January 16, 2026)
  • Z-1494-2026 Class II — Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Nam (January 8, 2026)
  • 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)