Agency classClass IIOur severity:High FDA (Devices)·Z-1987-2023·Announced 2023-06-28

Olympus QUICKCLIP PRO hemostatic clips recalled for deployment failures

Olympus is recalling 340 QUICKCLIP PRO hemostatic clips used in gastrointestinal endoscopy due to reports of deployment failures during procedures, including clips that fail to open, close, or detach properly.

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: This is an FDA Class II medical device with reported functional failures during clinical use. No injuries, hospitalizations, or deaths have been reported. The rubric classifies risk-of-harm products without reported injury as High (score 3).

Plain-English summary

Olympus Corporation of the Americas is recalling 340 units of the QUICKCLIP PRO 165 CM hemostatic clip (catalog number HX-202LR.A). This is a single-use device designed to control bleeding in the gastrointestinal tract during endoscopic procedures. The affected lot numbers are 24K, 27K, 29K, 2XK, and 2YK, distributed nationwide in the United States.

The recall was initiated due to reports of clip deployment failures occurring during clinical procedures. Complaints indicate that the clip arm does not open when the user pushes the slider, does not close when the user pulls the slider, and may detach from target tissue earlier than expected after deployment. These failures prevent the clips from achieving their intended hemostatic function, creating hazardous situations where the device does not work as expected.

This recall affects patients who underwent gastrointestinal endoscopy procedures using clips from the affected lot numbers.

The recalled product

Product: Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.A
Manufacturer: Olympus Corporation of the Americas
Category: Medical Device — Surgical Hemostasis
Hazard: deployment-failure
mechanical-failure
Affected units: 340

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 (5)

UDI-DI: 04953170385919 Lot Numbers: 24K
27K
29K
2XK
2YK

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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