FDAClass IIMay 7, 2025

Medline procedure kits recall

Medline procedure kits, labeled as: PLASTICS SUTURE TRAY, REF SUT13535

Why was Medline procedure kits recalled?

It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.

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?

UDI/DI 10653160144250 (EA) 40653160144251 (CS), Lot Numbers: 23JBU525

Product
Medline procedure kits, labeled as: PLASTICS SUTURE TRAY, REF SUT13535
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
120 units
Distribution
Worldwide distribution - US Nationwide and the countries of Panama and Canada.
Recall date
May 7, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls