The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2090-2026·Announced 2026-05-13

Medline Convenience Kits recalled for potential sterilization compromise

Medline Industries is recalling eight models of Convenience Kits due to calibration issues with sterilization equipment that may have affected 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 a potential risk of compromised sterility, which represents a significant risk of harm where sterile devices are essential to prevent infection. The source text explicitly states no illnesses or injuries have been reported, and the hazard is potential rather than confirmed, placing it at the upper end of High severity per the rubric.

Plain-English summary

Medline Industries, LP is recalling 1,774 units of eight models of Convenience Kits distributed nationwide. The recalled products include SCC RF PAIN MGMT kits (Models DYNJ56436A, DYNJ56436B, DYNJ56436C), CPNB SETUP TRAY kits (Models DYNJRA1979, DYNJRA1979A, DYNJRA1979B), VARITHENA TRAY 2 (Model DYNJRA2608), and CPNB SETUP TRAY (Model SAMPA0108).

The recall stems from calibration issues identified in the equipment used to sterilize and package the devices. While all products were exposed to validated sterilization and packaging cycles, the calibration problems create the potential to impact the sterility assurance level of the recalled kits.

Customers who have received these products should stop using them and contact Medline Industries for instructions on return or replacement. Specific lot numbers and UDI codes are provided to identify affected units. The FDA classification for this recall is Class II.

The recalled product

Product
Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number:DYNJ56436A; 2) SCC RF PAIN MGMT, Model Number:DYNJ56436B; 3) SCC RF PAIN MGMT, Model Number:DYNJ56436C; 4) CPNB SETUP TRAY, Model Number:DYNJRA1979; 5) CPNB SETUP TRAY, Model Number:DYNJRA1979A; 6) CPNB SETUP…
Manufacturer
Medline Industries, LP
Category
Medical Device — Sterile Kits / Surgical Trays
Hazard
Affected units
1,774

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) DYNJ56436A
  • UDI-DI: 10889942749874(each)
  • 40889942749875(case)
  • Lot Number: 21AMB799
  • 2) DYNJ56436A
  • Lot Number: 21BMC737
  • 3) DYNJ56436B
  • UDI-DI: 10193489869569(each)
  • 40193489869560(case)
  • Lot Number: 21DME244
  • 4) DYNJ56436C
  • UDI-DI: 10195327059668(each)
  • 40195327059669(case)
  • Lot Number: 23AMG574
  • 5) DYNJ56436C
  • Lot Number: 23DMA829
  • 6) DYNJ56436C
  • Lot Number: 23DMI776
  • 7) DYNJ56436C
  • Lot Number: 23EMH095

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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