The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-2114-2026·Announced 2026-05-13

Medline Surgical Convenience Kits recalled for sterilization calibration defect

Medline Industries is recalling multiple surgical convenience kits because equipment used to sterilize and package the devices had calibration issues that may have affected sterility assurance. The devices were processed through validated sterilization cycles but the calibration problems could impact their sterility.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class II recall involving surgical devices where sterilization integrity is compromised. Although no reported illnesses or injuries are stated in the source, devices with compromised sterility assurance used in invasive surgical procedures present serious risk of infection and consequent harm.

Plain-English summary

Medline Industries, LP is recalling approximately 160,980 units of multiple surgical convenience kits used in spinal, hip, and knee procedures. The recall affects various model numbers of SPINAL CDS, TOTAL HIP CDS-LF, TOTAL HIP PROCEDURE, and TOTAL KNEE CDS-LF kits distributed nationwide in the US.

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

Patients who have received these devices or healthcare facilities that have these kits in inventory should contact Medline Industries for guidance. The specific lot numbers affected are detailed in the FDA recall notice Z-2114-2026.

The recalled product

Product
See RES for complete list. Medline Convenience Kits: 1) SPINAL CDS, Model Number: CDS940087AG; 2) SPINAL CDS, Model Number: CDS940087AI; 3) TOTAL HIP CDS-LF, Model Number: CDS980832Q; 4) TOTAL HIP CDS-LF, Model Number: CDS980832R; 5) TOTAL HIP CDS-LF, Model Number: CDS980832S…
Manufacturer
Medline Industries, LP
Category
Medical Device — Surgical Convenience Kits / Sterilization
Hazard
Affected units
160,980

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) CDS940087AG
  • UDI-DI: 10193489847260(each)
  • 40193489847261(case)
  • Lot Number: 21EBC900
  • 2) CDS940087AI
  • UDI-DI: 10193489933758(each)
  • 40193489933759(case)
  • Lot Number: 21GBI183
  • 3) CDS940087AI
  • Lot Number: 21IBJ260
  • 4) CDS940087AI
  • Lot Number: 21JBF936
  • 5) CDS940087AI
  • Lot Number: 21KBH163
  • 6) CDS940087AI
  • Lot Number: 22BBY060
  • 7) CDS940087AI
  • Lot Number: 22EBA274
  • 8) CDS940087AI
  • Lot Number: 22EBF695

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 · sterilization failure

See all →

Similar recalls