The Recall Desk
Severity pendingFDA (Devices)·Z-1395-2026·Announced 2026-02-25

Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U; 2) MAJOR LAPAROTOMY

Pending LLM rewrite. Source: FDA_DEVICE Z-1395-2026.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English summary

Medline has 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.

The recalled product

Product
Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U; 2) MAJOR LAPAROTOMY CDS, Model Number: CDS860015V; 3) MAJOR LAPAROTOMY CDS, Model Number: CDS860015W; 4) MAJOR LAPAROTOMY CDS, Model Number: CDS860015X; 5) MINOR LAPAROTOMY CDS, Model Number: CD
Manufacturer
Medline Industries, LP
Category
Medical Device — Devices

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) CDS860015U
  • UDI-DI: 10193489847994(each)
  • 40193489847995(case)
  • Lot Number: 21LBT172
  • 2) CDS860015U
  • Lot Number: 21LBD726
  • 3) CDS860015U
  • Lot Number: 21KBB595
  • 4) CDS860015U
  • Lot Number: 21IBL031
  • 5) CDS860015U
  • Lot Number: 21GBS688
  • 6) CDS860015U
  • Lot Number: 21FBR386
  • 7) CDS860015V
  • UDI-DI: 10195327209582(each)
  • 40195327209583(case)
  • Lot Number: 22HBF170
  • 8) CDS860015W
  • UDI-DI: 10195327349509(each)

Distribution

Distributed nationwide across the United States.

Related recalls

Same category