Reported May 13, 2026 · Ongoing

See RES for complete list. Medline Convenience Kits

Medline Industries, LP

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Medline Industries, LP · 3 Lakes Dr · Northfield, IL · 60093-2753

Is this the product you have?

See RES for complete list. Medline Convenience Kits

9 of 9 products

Products covered by this recall
Model / numberProduct as published
CDS840015AQOPEN HEART CDS
CDS840015AQOPEN HEART CDS
CDS840023TOPEN HEART CDS
CDS840087AIOFF PUMP CABG CDS
CDS840087AKOFF PUMP CABG CDS
CDS840087ALOFF PUMP CABG CDS
CDS840087AMOFF PUMP CABG CDS
CDS840150SOPEN HEART
CDS840150TOPEN HEART
Lot codes and dates

358 of 358 products

Products covered by this recall
#BarcodesProduct as published
11019532721014440195327210145Lot Number: 23FLA191; 2) CDS840015AQ, UDI-DI: 10195327210144(each), 40195327210145(case)
21019348968206940193489682060Lot Number: 24ILB176; 3) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case)
31019348968206940193489682060Lot Number: 21CKA394; 4) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case)
41019348968206940193489682060Lot Number: 21EBN817; 5) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case)
51019348968206940193489682060Lot Number: 21GBH886; 6) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case)
61019348968206940193489682060Lot Number: 21IBG586; 7) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case)
71019348968206940193489682060Lot Number: 21KBW667; 8) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case)
81019348968206940193489682060Lot Number: 21LBV113; 9) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case)
91019348968206940193489682060Lot Number: 22CBC309; 10) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case)
101019348968206940193489682060Lot Number: 22EBK678; 11) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case)
111019348968206940193489682060Lot Number: 22GBQ917; 12) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case)
121019348968206940193489682060Lot Number: 22HBU935; 13) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case)
131019348968206940193489682060Lot Number: 22JBT770; 14) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case)
141019348968206940193489682060Lot Number: 22JBU353; 15) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case)
151019348968206940193489682060Lot Number: 22KBJ798; 16) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case)
161019348968206940193489682060Lot Number: 22KBL256; 17) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case)
171019348968206940193489682060Lot Number: 22KBW565; 18) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case)
181019348968206940193489682060Lot Number: 22OBM690; 19) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case)
191019348968206940193489682060Lot Number: 23ABE738; 20) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case)
201019348968206940193489682060Lot Number: 23ABM709; 21) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case)
Amount recalled
51061 units

This recall covers 42 products

The agency filed one notice per product. You are reading one of them; the other 41 are below.

29 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Medline Industries, LP recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:57 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.