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Benesta Hysteroscope Set

Caldera Medical, Inc. · Model CAL-TR111 · UDI-DI 00857492008041

HIH Prescription

510(k) clearances

8,602

Adverse events (41 deaths)

Recalls

134

Facilities

Description

Benesta Rod Lens Hysteroscope for viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and operative/surgical procedures. The Set contains: CAL-TR113 Benesta Hysteroscope CAL-TR112 Benesta Outflow Channel CAL-TR121 Benesta Hysteroscope Light Source Adapter (Storz/Olympus) CAL-TR122 Benesta Hysteroscope Light Source Adapter (Dyonics/Wolf) CAL-TR123 Benesta Stopcock Lever and Cap (2 each) CAL-TR124 Benesta Hysteroscope/Outflow Channel End Cap (2 each) CAL-TR125 Benesta Working Channel Brush, 3mm CAL-TR126 Benesta Inflow Channel Brush, 2mm

Recalls

Date	Firm	Reason
2026-08-24	Olympus Corporation of the Americas	There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.
2026-08-24	Olympus Corporation of the Americas	There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.
2026-05-21	Karl Storz Endoscopy	Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures may contain an expired single use endoscopic seal for gynecology use, which could
2025-11-11	Olympus Corporation of the Americas	Complaints of the ceramic tip of the resection sheath breaking have been received.
2025-06-18	Olympus Corporation of the Americas	Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
2025-06-18	Olympus Corporation of the Americas	Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
2024-04-18	Olympus Corporation of the Americas	The required leakage test was not performed following of a re-work for a non-conformity. This could potentially result in liquid ingress into the eyepiece and cause a foggy image.
2023-09-25	Aizu Olympus Co., Ltd.	Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endo
2023-09-25	Aizu Olympus Co., Ltd.	Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endo
2023-07-20	Olympus Corporation of the Americas	IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brushes.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.