The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2413-2023·Announced 2023-08-23

HF Resection Electrodes Recalled for Wire Breakage and Patient Fragment Hazard

Olympus HF Resection Electrodes are being recalled due to reports of loop wire breakage when contacting metal objects. Broken fragments can fall inside the patient and require retrieval.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device recall due to reported device failures (wire breakage) creating risk of serious patient harm (internal foreign body requiring retrieval). No hospitalizations or patient injuries explicitly reported in source, fitting the 'risk-of-harm products where injury has not yet been reported' criterion.

Plain-English summary

Olympus Corporation is recalling 62,704 boxes of HF Resection Electrodes (64 different models) due to device failure and patient safety risks. These electrodes are surgical instruments used in endoscopic procedures for urological and gynecological diagnosis and treatment.

The electrodes are being recalled because the loop wire at the distal end can break when contacting metal objects, such as other endoscopic equipment, implants, or stents. When the wire breaks, fragments can fall inside the patient and must be retrieved in a separate procedure. Additionally, there is a risk of sparkover (electrical arcing) when the electrode contacts metal parts, which can cause uncontrolled heating and damage to the electrode tip.

The recalled products have been distributed nationwide across the United States. Consumers who have these devices should contact Olympus Corporation of the Americas for guidance. Patients who have undergone procedures using these electrodes and experience unexpected symptoms should consult with their healthcare provider.

The recalled product

Product
HF Resection Electrodes - HF resection electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in urological or gynecological applications. 64 Models: 1) A22201C 2) A22201D 3) A22202C 4) A22203C 5) A22205C 6) A22205D 7) A22206C 8)…
Manufacturer
Olympus Corporation of the Americas
Category
Medical Device — Surgical / Endoscopic Equipment
Hazard
Affected units
62,704

Distribution

Distributed nationwide across the United States.

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