CLASS II ONGOING Device recall · Reported 28 Jun 2023 · FDA Enforcement Report
Single Use Repositionable Clip Quickclip PRO 5/BX- Intended recalled
Olympus Corporation of the Americas is recalling Single Use Repositionable Clip Quickclip PRO 5/BX- Intended for hemostatic metal clip for, distributed nationwide in the US. The recall was initiated on 4 May 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1990-2023
- FDA event ID
- 92325
- Recalling firm
- Olympus Corporation of the Americas, Center Valley, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 May 2023
- FDA classified
- 21 Jun 2023
- Reported
- 28 Jun 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 4 May 2023 | Recall initiated by company | |
| 21 Jun 2023 | Classified by FDA | +48 days |
| 28 Jun 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially causing harms to patients. The complaints include reports that: 1) the clip arm does not open when the user pushes the slider, 2) the clip arm does not close when the user pulls the slider and 3) the clip detaches from the target tissue earlier than expected, after being deployed in a procedure.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Single Use Repositionable Clip QUICKCLIP PRO 230CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202UR.B
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially causing harms to patients. The complaints include reports that: 1) the clip arm does not open when the user pushes the slider, 2) the clip arm does not close when the user pulls the slider and 3) the clip detaches from the target tissue earlier than expected, after being deployed in a procedure.
Which lots are affected?
UDI-DI: 04953170385940 Lot Numbers: 24K, 25K, 26K, 27K, 28K, 29K, 2XK, 2YK, 2ZK
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 92325This product is part of a recall event; the main page for the event is Single Use Repositionable Clip Quickclip PRO 10/BX recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Single Use Repositionable Clip Quickclip PRO 10/BX recalled | Olympus Corporation of the Americas | Device Malfunction | Nationwide | |
| CLASS II | Single Use Repositionable Clip Quickclip PRO 5/BX- Intended recalled | Olympus Corporation of the Americas | Device Malfunction | Nationwide | |
| CLASS II | Single Use Repositionable Clip Quickclip PRO 10/BX recalled | Olympus Corporation of the Americas | Device Malfunction | Nationwide |
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|---|---|---|---|---|---|
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