Agency classClass IIOur severity:High FDA (Devices)·Z-1990-2023·Announced 2023-06-28

Hemostatic Clip Device Recalled Due to Deployment Failures

Olympus recalls QUICKCLIP PRO hemostatic clips nationwide due to reported malfunction during clinical procedures, where clips fail to open, close, or detach from tissue as intended.

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 documented complaints of device malfunction during clinical use. While no hospitalization or injury reports are mentioned in the source, the risk-of-harm potential in a procedural medical device where failures occurred during patient procedures warrants a High severity rating.

Plain-English summary

Olympus Corporation of the Americas is recalling QUICKCLIP PRO 230CM hemostatic metal clips used for gastrointestinal procedures. The recall affects 3,795 units distributed nationwide across the United States.

The recall was initiated due to reported clip deployment failures during clinical procedures. The FDA received complaints documenting three types of malfunction: clips that fail to open when the user activates the deployment mechanism, clips that fail to close properly, and clips that detach from the target tissue earlier than expected after being placed in the procedure. These mechanical failures could prevent the device from functioning as intended and potentially cause patient harm.

Affected lot numbers are: 24K, 25K, 26K, 27K, 28K, 29K, 2XK, 2YK, and 2ZK. The product identifier is Catalog Number HX-202UR.B, with UDI-DI 04953170385940. Healthcare providers who have received this device should contact Olympus Corporation of the Americas for further instructions regarding use or replacement of affected units.

The recalled product

Product: Single Use Repositionable Clip QUICKCLIP PRO 230CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202UR.B
Manufacturer: Olympus Corporation of the Americas
Category: Medical Device — Endoscopy
Hazard: device-malfunction
deployment-failure
Affected units: 3,795

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 (9)

UDI-DI: 04953170385940 Lot Numbers: 24K
25K
26K
27K
28K
29K
2XK
2YK
2ZK

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Same manufacturer · Olympus Corporation of the Americas

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