The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1399-2026·Announced 2026-02-25

Medline Medical Device Convenience Kits Recalled Due to Sterilization Calibration Issues

Medline Industries is recalling 154,427 medical device convenience kits due to calibration issues with sterilization equipment that could affect sterility assurance levels. No illnesses or injuries have been reported.

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: FDA Class II recall with theoretical risk to sterility assurance level. No illnesses or injuries reported, but medical device sterility issues pose potential for harm if devices are not sterile when used.

Plain-English summary

Medline Industries, LP is recalling 154,427 units of Medline Convenience Kits due to issues with calibration of equipment used to sterilize and package the devices. The affected products include various drawer kits, neuro cart kits, transplant kits, procedure kits, and other medical device organization systems identified by multiple model numbers and lot numbers.

The recall affects products distributed worldwide, including throughout the United States. While all products were exposed to validated sterilization and packaging cycles, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the recalled products.

Healthcare facilities should stop using the affected products and contact Medline Industries for replacement or refund. Patients should contact their healthcare providers if they have concerns about potential exposure. No illnesses or injuries have been reported in connection with these products.

The recalled product

Product
Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326; 2) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326A; 3) DRAWER #5, Model Number: ACC010475; 4) DRAWER 1 NEURO CART, Model Number: ACC010542; 5) DRAWER 2 NEURO CART, Model Number…
Manufacturer
Medline Industries, LP
Category
Medical Device — Surgical and medical convenience kits
Hazard
Affected units
154,427

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) ACC010326
  • UDI-DI: 10889942735525(each)
  • 40889942735526(case)
  • Lot Number: 22HDA973
  • 2) ACC010326
  • Lot Number: 22BDB172
  • 3) ACC010326
  • Lot Number: 21LDA438
  • 4) ACC010326
  • Lot Number: 21CDB692
  • 5) ACC010326
  • Lot Number: 21CDB175
  • 6) ACC010326A
  • UDI-DI: 10195327347147(each)
  • 40195327347148(case)
  • Lot Number: 24GDA256
  • 7) ACC010326A
  • Lot Number: 23IDB293
  • 8) ACC010475
  • UDI-DI: 10193489469011(each)

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 →

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