The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2098-2026·Announced 2026-05-13

Medline Surgical Convenience Kits Recalled for Sterilization Calibration Issues

Medline Industries is recalling 114,778 surgical convenience kits due to calibration issues with sterilization equipment that may affect the sterility assurance level of the products. No illnesses or injuries have been reported.

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 used in surgical procedures. The hazard—potential loss of sterility assurance—could create risk of serious infection or contamination, and no illnesses have been reported yet, making this a high-risk situation without reported adverse outcomes.

Plain-English summary

Medline Industries, LP is recalling multiple surgical convenience kits, including Major Laparotomy, Minor Laparotomy, and Lap Gastric Bypass models, distributed nationwide and worldwide. The recall affects 114,778 units across numerous lot numbers and model variations.

Medline identified issues related to calibration of equipment used to sterilize and package these devices. Although all products were exposed to validated sterilization and packaging cycles, the calibration issues have the potential to impact the sterility assurance level (SAL) of the recalled products.

Patients and healthcare providers who have received these kits should contact their healthcare facility or Medline for guidance on next steps. The FDA classification for this recall is Class II. For a complete list of affected model numbers and lot numbers, consult the FDA's official recall notice.

The recalled product

Product
See RES for complete list. 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…
Manufacturer
Medline Industries, LP
Category
Medical Device — Surgical Kits / Sterilization
Hazard
Affected units
114,778

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

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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