Agency classClass IIOur severity:High FDA (Devices)·Z-1418-2023·Announced 2023-04-26

Olympus Single-Use Endoscopic Clip Fixing Device Recalled for Deployment Failure

Olympus is recalling single-use rotatable clip fixing devices used in endoscopy procedures. The clips may fail to deploy from the tube sheath during use.

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 with reported functional failure that poses a risk of harm during endoscopic procedures. No illnesses or injuries have been reported to date, placing this in the 'risk-of-harm' category where injury has not yet been realized.

Plain-English summary

Olympus Corporation of the Americas is recalling three models of single-use rotatable clip fixing devices: Models HX-201LR-135 (165cm), HX-201UR-135 (230cm), and HX-201UR-135L (230cm with long clip). These devices are used in endoscopic procedures and contain a rotatable clip designed to fix within a 2.8mm scope channel. Approximately 373 devices in 65.9 boxes were distributed nationwide in the United States.

Complaints have been received indicating that the clip did not come out of the tube sheath during procedures. This functional failure could impede the intended use of the device and affect patient care during endoscopic procedures.

Affected lot numbers are 1ZV (Model HX-201LR-135), 23V (Models HX-201UR-135), and 24V (Models HX-201UR-135 and HX-201UR-135L). Healthcare facilities and providers who have these devices should verify they do not have affected lots and should contact Olympus Corporation of the Americas for further guidance on the recall.

The recalled product

Product: Single Use Rotatable Clip Fixing Device Model HX 201LR 135 - Rotatable, 165cm long, 2.8 scope channel, standard clip Model HX 201UR 135 - Rotatable, 230 cm long, 2.8 scope channel, standard clip Model HX 201UR 135L - Rotatable, 230 cm long, 2.8 mm scope channel, Long clip
Manufacturer: Olympus Corporation of the Americas
Category: Medical Device — Endoscopic Equipment
Hazard: clip-deployment-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

1) UDI-DI 14953170353106
Model HX-201LR-135
Lot 1ZV 2) UDI-DI 14953170353113
Model HX-201UR-135
Lot 23V 3) UDI-DI 14953170353120
Lot 24V 4) UDI-DI 14953170353168
Model HX-201UR-135L
Lot 24V

Distribution

Distributed nationwide across the United States.

Same manufacturer · Olympus Corporation of the Americas

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