Agency classClass IIOur severity:High FDA (Devices)·Z-1413-2026·Announced 2026-02-25

Medline Convenience Kits Recalled Due to Potential Sterility Assurance Issues

Medline Industries, LP is recalling various Medline Convenience Kits because equipment calibration issues may have impacted the sterility assurance level of the products.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves medical devices where a potential loss of sterility poses a high risk of harm, though no injuries have been reported.

Plain-English summary

Medline Industries, LP has identified issues regarding the calibration of equipment used to sterilize and package several Medline Convenience Kits. While all products were exposed to validated sterilization and packaging cycles, the calibration errors create a potential risk to the sterility assurance level (SAL) of the devices.

This recall affects various Medline Convenience Kits, including neuro shunts and various neuro packs, distributed worldwide and across the United States.

Consumers and healthcare providers should check their inventory for the affected model numbers and lot numbers listed in the official notice.

The recalled product

Product: Medline Convenience Kits: 1) NEURO SHUNT- CODMAN, Model Number: CDS860018G; 2) NEURO SHUNT- CODMAN, Model Number: CDS860018I; 3) KIT NEUR FUS LUM POST CRANDALL, Model Number: DYKMBNDL138; 4) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142; 5) KIT NEURO FUS LUM…
Manufacturer: Medline Industries, LP
Category: Medical Device — Surgical Kits
Hazard: sterility-risk
Affected units: 7,494

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

1) CDS860018G
UDI-DI: 10889942459643(each)
40889942459644(case)
Lot Number: 23CMH970
2) CDS860018G
Lot Number: 23CMD444
3) CDS860018G
Lot Number: 23AMJ086
4) CDS860018G
Lot Number: 22KMF991
5) CDS860018G
Lot Number: 22HMC764
6) CDS860018G
Lot Number: 22DMD555
7) CDS860018G
Lot Number: 21LMG598
8) CDS860018G
Lot Number: 21KMD971
9) CDS860018G
Lot Number: 21JMH357

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 42 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 42 products in this recall →

Same manufacturer · Medline Industries, LP

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Same hazard · sterility risk