FDAClass IIApril 26, 2023

Single Use Rotatable Clip Fixing Device recall

Single Use Rotatable Clip Fixing Device Model HX 201LR 135 - Rotatable, 165cm long, 2.8 scope channel, standard clip Model HX 201UR 135 - Rotatable…

Why was Single Use Rotatable Clip Fixing Device recalled?

There have been complaints that the clip did not come out of the tube sheath during the procedure.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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…
Recalling firm
Olympus Corporation of the Americas
Quantity
65.9 boxes (373 pieces)
Distribution
US Nationwide Distribution
Recall date
April 26, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls