Olympus recalls single-use GI clips that may deploy incorrectly, causing patient harm. Affected clips have specific lot numbers and catalog codes.
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 GI clips that may fail to deploy correctly during medical procedures, potentially causing patient harm. This could lead to clips not opening, closing, or staying attached as intended.
The clips may not open when pushed, not close when pulled, or detach prematurely from tissue. This can cause the clips to fail during critical medical procedures, potentially harming patients.
Healthcare professionals using the clips for gastrointestinal procedures are most at risk. Patients undergoing these procedures may experience complications if the clips fail.
Check for catalog number HX-202LR.B and lot numbers 24K, 26K, 27K, 29K, 2XK, or 2YK. The product is a single-use clip for gastrointestinal procedures.
Verify the catalog number and lot numbers listed in the recall notice.
The recall is due to complaints that the clips may deploy incorrectly during procedures, leading to potential patient harm.
The clips may not open when pushed, not close when pulled, or detach from tissue earlier than expected.
Check for catalog number HX-202LR.B and lot numbers 24K, 26K, 27K, 29K, 2XK, or 2YK.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1988-2023 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1988-2023 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.