Olympus recalls single-use GI clips that may deploy incorrectly, causing patient harm. Affected units have catalog numbers HX-202UR.A and lot numbers 24K-2ZK.
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.
Olympus is recalling single-use hemostatic clips for GI procedures because they sometimes fail to deploy correctly. This could lead to clips not closing properly or detaching from tissue, potentially causing patient harm.
The clips may not open when pushed, not close when pulled, or detach from tissue too early. This can cause them to fail during critical procedures, potentially harming patients.
Healthcare professionals using the clips during GI procedures are most at risk. Patients undergoing these procedures may experience complications if the clips fail to function as intended.
Check for catalog number HX-202UR.A and lot numbers 24K through 2ZK on the packaging. These clips are intended for use in gastrointestinal procedures.
Test if the clip opens when pushed and closes when pulled before use.
The clips have been reported to fail during procedures, including not opening when pushed, not closing when pulled, or detaching from tissue too early.
The recall record does not specify a remedy, so contact Olympus directly for guidance.
Look for catalog number HX-202UR.A and lot numbers 24K through 2ZK on the packaging.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1989-2023 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1989-2023 from Olympus. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
