The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2089-2026·Announced 2026-05-13

Medline Convenience Kits recalled due to sterilization calibration issue

Medline is recalling two models of Convenience Kits because calibration issues with sterilization and packaging equipment may have compromised the sterility assurance level of the devices.

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: This is an FDA Class II recall involving medical devices with potential compromise to sterility assurance level, a quality control failure with risk of serious harm. The source does not report any illnesses or injuries, so the score is at most 3 per the rubric; however, the nature of the defect—compromised sterility in surgical kits—and the Class II classification elevate this to High rather than Moderate.

Plain-English summary

Medline Industries, LP is recalling Medline Convenience Kits, Model ANCILLARY PACK-LF (Model Number DYNJ0185290G) and OPEN HEART ANESTHESIA ICC-A (Model Number DYNJ905567A), with 599 units distributed nationwide and worldwide.

Medline identified calibration issues with the equipment used to sterilize and package these devices. Although all products were exposed to validated sterilization and packaging cycles, the calibration problems have the potential to impact the sterility assurance level of the recalled products, meaning the devices may not meet required sterility standards.

Consumers and healthcare facilities using these products should contact Medline for instructions on returns or replacements. The specific lot numbers affected are listed in the recall notice, and the FDA classification for this recall is Class II.

The recalled product

Product
Medline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number:DYNJ0185290G; 2) OPEN HEART ANESTHESIA ICC-A, Model Number:DYNJ905567A
Manufacturer
Medline Industries, LP
Category
Medical Device — Surgical Kit / Anesthesia
Hazard
Affected units
599

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) DYNJ0185290G
  • UDI-DI: 10193489378054(each)
  • 40193489378055(case)
  • Lot Number: 22LBQ336
  • 2) DYNJ905567A
  • UDI-DI: 10193489348927(each)
  • 40193489348928(case)
  • Lot Number: 21EBE777
  • 3) DYNJ905567A
  • Lot Number: 21GBE802
  • 4) DYNJ905567A
  • Lot Number: 21IBH675
  • 5) DYNJ905567A
  • Lot Number: 21KBA253
  • 6) DYNJ905567A
  • Lot Number: 21KBR457
  • 7) DYNJ905567A
  • Lot Number: 22CBY841
  • 8) DYNJ905567A
  • Lot Number: 22HBF686

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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