Z-1989-2023Class II

Single Use Repositionable Clip QUICKCLIP PRO 230 CM 10/BX- Intended for hemostatic metal clip for the GI...

Name: Z-1989-2023 Single Use Repositionable Clip QUICKCLIP PRO 230 CM 10/BX- Intended for hemostatic metal clip for the GI...
Creator: Olympus Corporation of the Americas
Published: 2023-05-04
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2023-05-04 / Open, Classified

FDA source

Olympus Corporation of the Americas began a recall of Single Use Repositionable Clip QUICKCLIP PRO 230 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202UR.A on 2023-05-04. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1989-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-04
Posted: 2023-06-21
Recalling firm: OLYMPUS Corporation of the Americas
Product: Single Use Repositionable Clip QUICKCLIP PRO 230 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202UR.A
Product code: PKL Hemostatic Metal Clip For The Gi Tract
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.
FDA root cause: Under Investigation by firm
Action: Olympus issued Urgent Medical Device Recall Letter dated 5/4/23. Letter states reason for recall, health risk and action to take: 1. Immediately assess any product you have to identify HX-202LR/UR with affected lot number listed in this communication, cease use of product and quarantine any affected product. The images in Attachment 1 depict the area where the lot number is identified. The lot# is on the carton box, pack and handle. 2. Contact our Olympus Customer Service Team at 1-800-848-9024, option 2. Olympus will issue a Return Material Authorization to return any affected product at no charge to you. Olympus will issue a credit to your facility upon return of affected product. 3. Olympus requests that you acknowledge receipt of this letter through the Olympus recall portal. a. Go to https://olympusamerica.com/recall b. Enter the recall number: 0424 c. Complete the form as instructed. 4. If you have distributed these devices outside your facility, please notify your customers of this matter immediately. Your notification to your customers may be enhanced by including a copy of this letter. Contact (647) 999-3203 or at [email protected] for any additional information or support concerning this matter.
Quantity in commerce: 13707 pieces
Distribution: US Nationwide distribution.
Product codes and lots: UDI-DI: 04953170385933 Lot Numbers: 24K, 25K, 26K, 27K, 28K, 29K, 2XK, 2YK, 2ZK

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1989-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1987-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-28	2023-06-21
Z-1988-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-28	2023-06-21
Z-1989-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-28	2023-06-21
Z-1990-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-28	2023-06-21

Product code PKL

K123601Class IISingle Use Repositionable ClipOlympus Medical Systems Corp. / cleared 2013-04-29

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)