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Single Use Repositionable Clip HX-202LR

by Olympus Medical Systems Corporation EUDAMEDGUDID

Active European Union Open recall

Ref N4509030

Regulatory status

as of 28 Oct 2026

Recall ongoing. 4 ongoing FDA recalls name this device. See recalls

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04953170345166 Basic UDI-DIDate5 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04953170345166 UDI-DIDate21 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

4 recalls · 4 ongoing · FDA

  • 4 recalls, same reason

    • Ongoing Z-1987-2023 FDA Class II initiated 4 May 2023
    • Ongoing Z-1988-2023 FDA Class II initiated 4 May 2023
    • Ongoing Z-1990-2023 FDA Class II initiated 4 May 2023
    • Ongoing Z-1989-2023 FDA Class II initiated 4 May 2023

    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.

Specification

EUDAMED · GUDID

Trade Name
Single Use Repositionable Clip HX-202LR EUDAMED
Single Use Repositionable Clip GUDID
Generic Name
Ligation clip, metallic
Device Name
Clip
Model / Reference
N4509030 EUDAMED
HX-202LR GUDID
Primary DI / UDI-DI
04953170345166
Basic UDI-DI
B-04953170345166
FDA Product Code
PKL
EMDN Code
G030202 Digestive endoscopy, haemostasis clips
GMDN Term
Ligation clip, metallic
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
876.4400
Market of Registration
Germany
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Conditional

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
N4509030
GUDID
HX-202LR
Device ClassEUDAMED
Class IIa
GUDID
Class II
ImplantableEUDAMED
No
GUDID
Yes

Related devices

Cleared under the same submission (K123601)

Other devices from Olympus Medical Systems Corporation

See all devices from Olympus Medical Systems Corporation →

Properties

  • Sterile
  • Single Use
  • Implantable NoEUDAMEDYesGUDID
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No