The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1420-2026·Announced 2026-02-25

Medline Medical Device Kits Recalled Due to Sterilization Calibration Issues

Medline Industries is recalling 4,853 medical device kits due to potential sterility issues from equipment calibration problems during manufacturing.

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 potential impact on sterility assurance level, representing a risk-of-harm product where injury has not yet been reported per the severity rubric criteria.

Plain-English summary

Medline Industries, LP is recalling 4,853 units of various medical device convenience kits, including ophthalmic rupture globe kits, ophthalmology kits, surgical oncology kits, and other eye and breast reconstruction kits. The recall affects products with specific model numbers and lot numbers distributed worldwide, including in the United States.

The recall is being issued because Medline identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

Healthcare facilities and patients should stop using the affected products immediately. Consumers should return the products to their point of purchase or contact Medline for instructions on proper disposal or replacement. No injuries or illnesses have been reported in connection with these products.

The recalled product

Product
Medline Convenience Kits: 1) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104; 2) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104A; 3) KIT OPHTHALMOLOGY CORNEAL TRAN, Model Number: DYKMBNDL159; 4) KIT OPHTHALMOLOGY CATARACT, Model Number: DYKMBNDL180; 5)…
Manufacturer
Medline Industries, LP
Category
Medical Device — Surgical / Ophthalmic Kits
Hazard
Affected units
4,853

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) DYKMBNDL104
  • UDI-DI: 10193489478945(each)
  • 40193489478946(case)
  • Lot Number: 22GBP895
  • 2) DYKMBNDL104
  • Lot Number: 21IBV636
  • 3) DYKMBNDL104
  • Lot Number: 21FBP706
  • 4) DYKMBNDL104
  • Lot Number: 21ABV400
  • 5) DYKMBNDL104A
  • UDI-DI: 10195327240622(each)
  • 40195327240623(case)
  • Lot Number: 24EBU650
  • 6) DYKMBNDL104A
  • Lot Number: 23HBV380
  • 7) DYKMBNDL104A
  • Lot Number: 22KBO773
  • 8) DYKMBNDL104A
  • Lot Number: 22JBS907

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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