The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1386-2026·Announced 2026-02-25

Medline Convenience Kits and CPNB Setup Trays Recalled Due to Sterilization Calibration Issues

Medline Industries is recalling 779 units of convenience kits and setup trays due to potential sterility assurance 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 theoretical risk to sterility assurance level where injury has not yet been reported. Per rubric, risk-of-harm products without reported injury qualify as High severity.

Plain-English summary

Medline Industries, LP is recalling 779 units of Medline Convenience Kits and CPNB Setup Trays due to issues with calibration of the equipment used to sterilize and package the devices. The affected products include multiple model numbers: DYNJ56436A, DYNJ56436B, DYNJRA1979, DYNJRA1979A, and SAMPA0108.

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

Consumers should stop using the affected products immediately and contact Medline Industries for a replacement or refund. Healthcare facilities should quarantine the products and await further instructions from the company.

The recalled product

Product
Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number: DYNJ56436A; 2) SCC RF PAIN MGMT, Model Number: DYNJ56436B; 3) CPNB SETUP TRAY, Model Number: DYNJRA1979; 4) CPNB SETUP TRAY, Model Number: DYNJRA1979A; 5) CPNB SETUP TRAY, Model Number: SAMPA0108
Manufacturer
Medline Industries, LP
Category
Medical Device — Surgical/Clinical Equipment
Hazard
Affected units
779

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: 21BMC737
  • 2) DYNJ56436A
  • Lot Number: 21AMB799
  • 3) DYNJ56436B
  • UDI-DI: 10193489869569(each)
  • 40193489869560(case)
  • Lot Number: 21DME244
  • 4) DYNJRA1979
  • UDI-DI: 10195327186852(each)
  • 40195327186853(case)
  • Lot Number: 22IBU628
  • 5) DYNJRA1979
  • Lot Number: 22GBV936
  • 6) DYNJRA1979A
  • UDI-DI: 10195327649258(each)
  • 40195327649259(case)
  • Lot Number: 25DME153

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 →

Related recalls

Same manufacturer · Medline Industries, LP

See all →

Same hazard · sterility failure

See all →

Similar recalls