Z-1418-2023Class II

Single Use Rotatable Clip Fixing Device Model HX 201LR 135 - Rotatable, 165cm long, 2.8 scope channel...

Name: Z-1418-2023 Single Use Rotatable Clip Fixing Device Model HX 201LR 135 - Rotatable, 165cm long, 2.8 scope channel...
Creator: Olympus Corporation of the Americas
Published: 2023-02-23
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2023-02-23 / Open, Classified

FDA source

Olympus Corporation of the Americas began a recall of Single Use Rotatable Clip Fixing Device Model HX 201LR 135 - Rotatable, 165cm long, 2.8 scope channel, standard clip Model HX 201UR 135 - Rotatable, 230 cm... on 2023-02-23. FDA classified it as Class II and gives the reason as "There have been complaints that the clip did not come out of the tube sheath during the procedure". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1418-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-02-23
Posted: 2023-04-20
Recalling firm: OLYMPUS Corporation of the Americas
Product: Single Use Rotatable Clip Fixing Device Model HX 201LR 135 - Rotatable, 165cm long, 2.8 scope channel, standard clip Model HX 201UR 135 - Rotatable, 230 cm long, 2.8 scope channel, standard clip Model HX 201UR 135L - Rotatable, 230 cm long, 2.8 mm scope channel, Long clip
Product code: MND Ligator, Esophageal
Reason for recall: There have been complaints that the clip did not come out of the tube sheath during the procedure.
FDA root cause: Process change control
Action: The firm, Olympus, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated 2/23/2023 to its customers. The letter described the product, the issue and actions to be taken. The customers were instructed to do the following: 1) immediately assess, cease use of and quarantine any affected (lot numbers) products you have identified. 2.) Call your Olympus customer service representative at 1-800-848-9024, option 2 to receive a RMA to return any affected product at not charge. 3.)Access the Olympus recall portal to indicate that you have received this notification at https://olympusamerica.com/recall. Enter the recall number "0421" and provide your contact information as indicated in the portal. 4.) If you have distributed these devices outside your facility, please notify your customers of this removal action immediately. Please report to Olympus any adverse events and irregularity associated with the use of the devices by contacting our Technical Assistance Center at 1 800 848 9024, option 1. Please reach out to your local sales representative for assistance regarding current product offerings. If you require additional information, please do not hesitate to contact me at (647) 999-3203 or [email protected].
Quantity in commerce: 65.9 boxes (373 pieces)
Distribution: US Nationwide Distribution
Product codes and lots: 1) UDI-DI 14953170353106; Model HX-201LR-135; Lot 1ZV 2) UDI-DI 14953170353113; Model HX-201UR-135; Lot 23V 3) UDI-DI 14953170353120; Model HX-201UR-135; Lot 24V 4) UDI-DI 14953170353168; Model HX-201UR-135L; Lot 24V

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1418-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1418-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-26	2023-04-20

Product code MND

K013066Class IIHx-5/6-1 Endoscopic Clipping DeviceOlympus America, Inc. / cleared 2001-12-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)