The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1390-2026·Announced 2026-02-25

Medline Cardiac Surgical Convenience Kits Recalled Due to Sterility Calibration Issues

Medline Industries is recalling cardiac surgical convenience kits due to sterilization equipment calibration issues that could affect device sterility assurance levels.

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 medical device recall with potential sterility assurance level impact. No illnesses or injuries reported, but risk-of-harm products where injury has not yet been reported. Sterility failure in medical devices poses significant risk of post-operative infections.

Plain-English summary

Medline Industries, LP is recalling 39,315 units of various cardiac surgical convenience kits, including OPEN HEART CDS, OFF PUMP CABG CDS, PACEMAKER CDS, and other cardiac device kits. The recall affects products with multiple model numbers used in cardiac and vascular procedures. The company identified calibration issues with equipment used to sterilize and package the devices, which could impact the sterility assurance level (SAL) of the recalled products. All products were exposed to validated sterilization and packaging cycles, but the calibration issues present a potential risk to sterility. The affected products were distributed worldwide, including throughout the United States. Healthcare facilities should stop using the recalled products and contact Medline for replacement.

The recalled product

Product
Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840015AQ; 2) OPEN HEART CDS, Model Number: CDS840023T; 3) OFF PUMP CABG CDS, Model Number: CDS840087AI; 4) OFF PUMP CABG CDS, Model Number: CDS840087AK; 5) OFF PUMP CABG CDS, Model Number: CDS840087AL; 6)…
Manufacturer
Medline Industries, LP
Category
Medical Device — Cardiac Surgical Devices
Hazard
Affected units
39,315

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) CDS840015AQ
  • UDI-DI: 10195327210144(each)
  • 40195327210145(case)
  • Lot Number: 23FLA191
  • 2) CDS840023T
  • UDI-DI: 10193489682069(each)
  • 40193489682060(case)
  • Lot Number: 23LBM199
  • 3) CDS840023T
  • Lot Number: 23KBM369
  • 4) CDS840023T
  • Lot Number: 23JBU616
  • 5) CDS840023T
  • Lot Number: 23IBJ759
  • 6) CDS840023T
  • Lot Number: 23IBJ571
  • 7) CDS840023T
  • Lot Number: 23GBA105
  • 8) CDS840023T
  • Lot Number: 23CBO830

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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