FDAClass IISeptember 9, 2026

Medline Convenience Kits: 1) DRAWER 9 CRICOTHYROTOMY recall: Sterility Concern

Medline Convenience Kits: 1) DRAWER 9 CRICOTHYROTOMY KIT, Model Number: ACC010741; 2) KIT ANESTHESIA L&D A- LINE SET, Model Number: DYKMBNDL199A

Why was Medline Convenience Kits: 1) DRAWER 9 CRICOTHYROTOMY recalled?

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

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) ACC010741, UDI-DI: 10195327515515(each), 40195327515516(case), Lot Number: 23KDB215; 2) DYKMBNDL199A, UDI-DI: 10193489848540(each), 40193489848541(case), Lot Number: 24LBT847; 3) DYKMBNDL199A, UDI-DI: 10193489848540(each), 40193489848541(case), Lot Number: 24LBB138

Product
Medline Convenience Kits: 1) DRAWER 9 CRICOTHYROTOMY KIT, Model Number: ACC010741; 2) KIT ANESTHESIA L&D A- LINE SET, Model Number: DYKMBNDL199A
Recalling firm
Medline Industries, LP
Quantity
104 kits
Distribution
US Nationwide distribution.
Recall date
September 9, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls