Class II U.S. Food and Drug Administration

Medline Convenience Kits: 1) Open Heart CDS recall: Medline has identified issues related to calibration of the equipment used

Recall published 8 months ago

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 hazard: Sterility or particulate concern

This recall is about sterility assurance. It does not mean every unit is contaminated — it means the manufacturer cannot demonstrate that none of them is.

What the notice says: 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.

Why it matters: The product was made or packaged in conditions that cannot assure sterility, or visible particles were found in it. For anything injected, infused or used in the eye, that is a direct route for contamination into the body.

Symptoms and when to call a doctor

Watch for fever, chills, pain, redness, swelling or discharge at an injection site, and for a red, painful or suddenly blurred eye after using an eye product. Any of these needs same-day medical attention. Do not wait to see whether it settles, and tell the clinician which product and lot you used so it can be reported against the recall.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-1390-2026
Published
February 25, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Medline Industries, LP
Product type
Medical devices
Units affected
39315 units
Distribution
Nationwide
Made in
United States
Lot / code info
1) CDS840015AQ, UDI-DI: 10195327210144(each), 40195327210145(case), Lot Number: 23FLA191; 2) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23LBM199; 3) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23KBM369; 4) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23JBU616; 5) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23IBJ759; 6) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23IBJ571; 7) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23GBA105; 8) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23CBO830; 9) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23ABM709; 10) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23ABE738; 11) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22OBM690; 12) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22KBW565; 13) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22KBL256; 14) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22KBJ798; 15) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22JBU353; 16) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22JBT770; 17) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22HBU935; 18) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22GBQ917; 19) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22EBK678; 20) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22CBC309; 21) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 21LBV113; 22) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 21KBW667; 23) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 21IBG586; 24) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 21GBH886; 25) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 21EBN817; 26) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 21CKA394; 27) CDS840087AI, UDI-DI: 10193489847413(each), 40193489847414(case), Lot Number: 21ELA419; 28) CDS840087AI, UDI-DI: 10193489847413(each), 40193489847414(case), Lot Number: 21DLA296; 29) CDS840087AK, UDI-DI: 10195327212353(each), 40195327212354(case), Lot Number: 23ELA870; 30) CDS840087AL, UDI-DI: 10195327590406(each), 40195327590407(case), Lot Number: 24KLA701; 31) CDS840150S, UDI-DI: 10193489862409(each), 40193489862400(case), Lot Number: 21EBK732; 32) CDS840150S, UDI-DI: 10193489862409(each), 40193489862400(case), Lot Number: 21DBA306; 33) CDS840150T, UDI-DI: 10193489996197(each), 40193489996198(case), Lot Number: 21JBA896; 34) CDS840150U, UDI-DI: 10195327055318(each), 40195327055319(case), Lot Number: 22LBS336; 35) CDS840150U, UDI-DI: 10195327055318(each), 40195327055319(case), Lot Number: 22JBD465; 36) CDS840150U, UDI-DI: 10195327055318(each), 40195327055319(case), Lot Number: 22GBD762; 37) CDS840150U, UDI-DI: 10195327055318(each), 40195327055319(case), Lot Number: 22EBL398; 38) CDS840150U, UDI-DI: 10195327055318(each), 40195327055319(case), Lot Number: 22CBF996; 39) CDS840150U, UDI-DI: 10195327055318(each), 40195327055319(case), Lot Number: 22ABA269; 40) CDS840150V, UDI-DI: 10195327298401(each), 40195327298402(case), Lot Number: 24ABJ652; 41) CDS840150V, UDI-DI: 10195327298401(each), 40195327298402(case), Lot Number: 23KBC879; 42) CDS840150V, UDI-DI: 10195327298401(each), 40195327298402(case), Lot Number: 23KBC675; 43) CDS840150V, UDI-DI: 10195327298401(each), 40195327298402(case), Lot Number: 23HBJ716; 44) CDS840150V, UDI-DI: 10195327298401(each), 40195327298402(case), Lot Number: 23EBB628; 45) CDS840150V, UDI-DI: 10195327298401(each…
UPC codes
10195327210144, 40195327210145, 10193489682069, 40193489682060, 10193489847413, 40193489847414, 10195327212353, 40195327212354, 10195327590406, 40195327590407, 10193489862409, 40193489862400, 10193489996197, 40193489996198, 10195327055318, 40195327055319, 10195327298401, 40195327298402

Products covered by this recall

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) OPEN HEART, Model Number: CDS840150S; 7) OPEN HEART, Model Number: CDS840150T; 8) OPEN HEART, Model Number: CDS840150U; 9) OPEN HEART, Model Number: CDS840150V; 10) OPEN HEART, Model Number: CDS840150W; 11) UNIVERSAL HEART CDS, Model Number: CDS840246O; 12) GENERAL AAA #11-RF, Model Number: CDS840261AB; 13) OPEN HEART ADULT, Model Number: CDS840396AA; 14) OPEN HEART ADULT, Model Number: CDS840396AB; 15) OPEN HEART ADULT, Model Number: CDS840396X; 16) OPEN HEART ADULT, Model Number: CDS840396Y; 17) OPEN HEART CDS, Model Number: CDS840428K; 18) OPEN HEART CDS, Model Number: CDS840428L; 19) PACEMAKER CDS, Model Number: CDS980839C; 20) KIT, CVC ADD A PACK HUM-LF, Model Number: CDS982564C; 21) OPEN HEART ADULT HUM, Model Number: CDS982566K; 22) OPEN HEART BOX 1 CDS MRH, Model Number: CDS982575K; 23) OPEN HEART BOX 1 CDS MRH, Model Number: CDS982575M; 24) OPEN HEART BOX 1 CDS MRH, Model Number: CDS982575O; 25) OPEN HEART BOX 1 CDS MRH, Model Number: CDS982575P; 26) OPEN HEART, Model Number: CDS983348S; 27) HEART CABG CDS, Model Number: CDS983376Q; 28) HEART CABG CDS, Model Number: CDS983376T; 29) HEART CABG CDS, Model Number: CDS983376U; 30) HEART CABG CDS, Model Number: CDS983376V; 31) OPEN HEART CDS, Model Number: CDS983513F; 32) OPEN HEART ADULT PART 2 CDS, Model Number: CDS983786D; 33) OPEN HEART ADULT PART 2 CDS, Model Number: CDS983786F; 34) OPEN HEART ADULT PART 2 CDS, Model Number: CDS983786G; 35) PEDS CARDIAC CDS, Model Number: CDS984117F; 36) OPEN HEART CDS, Model Number: CDS984276P; 37) OPEN HEART ACCESSORY CDS, Model Number: CDS984289J; 38) OPEN HEART ACCESSORY CDS, Model Number: CDS984289K; 39) OPEN HEART ACCESSORY CDS, Model Number: CDS984289L; 40) OPEN HEART ACCESSORY CDS, Model Number: CDS984289M; 41) OPEN HEART ACCESSORY CDS, Model Number: CDS984289N; 42) OPEN HEART ACCESSORY CDS, Model Number: CDS984289O; 43) OPEN HEART CDS, Model Number: CDS984355F; 44) OPEN HEART CDS, Model Number: CDS984355G; 45) OPEN HEART CDS, Model Number: CDS984355I; 46) OPEN HEART CDS, Model Number: CDS984355J; 47) OPEN HEART A, Model Number: CDS985105M; 48) OPEN HEART A, Model Number: CDS985105N; 49) OPEN HEART A, Model Number: CDS985105O; 50) VASCULAR CDS, Model Number: CDS985215C; 51) BASE HEART PACK-LF, Model Number: CVT159AA; 52) ENDO KIT, Model Number: DYKE1580B; 53) KIT VASCULAR MINOR, Model Number: DYKMBNDL11; 54) KIT VASCULAR CAROTID, Model Number: DYKMBNDL118; 55) KIT VASCULAR CAROTID, Model Number: DYKMBNDL118A; 56) KIT VASCULAR BYPASS GRAFT GENE, Model Number: DYKMBNDL120; 57) KIT VASCULAR PERCUTANEOUS TEVA, Model Number: DYKMBNDL14; 58) KIT VASCULAR PERCUTANEOUS TEVA, Model Number: DYKMBNDL14A; 59) KIT VASCULAR VNS, Model Number: DYKMBNDL152; 60) KIT VASCULAR VNS, Model Number: DYKMBNDL152A; 61) KIT THORACIC SYMPHATECTOMY, Model Number: DYKMBNDL187; 62) KIT UROLOGY PERIPHERAL STIMULA, Model Number: DYKMBNDL189B; 63) KIT VASCULAR ENDOVENOUS ABLATI, Model Number: DYKMBNDL191; 64) KIT VASCULAR ANGIOGRAM GENERIC, Model Number: DYKMBNDL192; 65) KIT VASCULAR ENDOVENOUS ABLATI, Model Number: DYKMBNDL203; 66) KIT VASCULAR MEDIAN ARCUATE, Model Number: DYKMBNDL209A; 67) KIT VASCULAR MEDIAN ARCUATE, Model Number: DYKMBNDL209B; 68) CARDIAC ADULT CABG, Model Number: DYKMBNDL20A; 69) CARDIAC ADULT CABG, Model Number: DYKMBNDL20B; 70) KIT CARDIAC CSICU ADULT ECMO, Model Number: DYKMBNDL21; 71) KIT VASCULAR AAA REPAIR, Model Number: DYKMBNDL23A; 72) KIT CARDIAC ANEURYSM, Model Number: DYKMBNDL27A; 73) KIT CARDIAC ANEURYSM, Model Number: DYKMBNDL27B; 74) KIT PEDS CARDIAC ADULT, Model Number: DYKMBNDL4

Check your product

The notice names 58 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 10195327210144
  • 40195327210145
  • 10193489682069
  • 40193489682060
  • 10193489847413
  • 40193489847414
  • 10195327212353
  • 40195327212354
  • 10195327590406
  • 40195327590407
  • 10193489862409
  • 40193489862400
  • 10193489996197
  • 40193489996198
  • 10195327055318
  • 40195327055319
  • 10195327298401
  • 40195327298402

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 23FLA191
  • 23LBM199
  • 23KBM369
  • 23JBU616
  • 23IBJ759
  • 23IBJ571
  • 23GBA105
  • 23CBO830
  • 23ABM709
  • 23ABE738
  • 22OBM690
  • 22KBW565
  • 22KBL256
  • 22KBJ798
  • 22JBU353
  • 22JBT770
  • 22HBU935
  • 22GBQ917
  • 22EBK678
  • 22CBC309

Model or item number

On the rating label, the box or the instruction sheet.

  • CDS840015AQ
  • CDS840023T
  • CDS840087AI
  • CDS840087AK
  • CDS840087AL
  • CDS840150S
  • CDS840150T
  • CDS840150U
  • CDS840150V
  • CDS840150W
  • CDS840246O
  • CDS840261AB
  • CDS840396AA
  • CDS840396AB
  • CDS840396X
  • CDS840396Y
  • CDS840428K
  • CDS840428L
  • CDS980839C
  • CDS982564C

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Sterility

Medline Industries, LP — This recall is about sterility assurance. It does not mean every unit is contaminated — it means the manufacturer cannot demonstrate that none of them is.

  1. Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
  2. If you are a clinic or pharmacy, quarantine the stock and work it through your usual recall log.
  3. Report any infection or reaction you think the product caused to FDA MedWatch.
  4. Do not use a vial or syringe with visible particles, cloudiness or discolouration, whether or not it is on the recall list.

Refunds and replacements

With medicines, a replacement supply matters more than cash, and that is what pharmacies are set up to provide.

  • Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.
  • For a mail-order or online pharmacy, use the recall line listed on this page rather than the general support queue.
  • If the recall voided a fill you had already paid for, your insurer will normally authorise a replacement ahead of schedule. Quote the recall number.
  • If you paid out of pocket, ask for a refund of the co-pay or purchase price and keep the receipt the pharmacy issues.

Company contact: Medline Industries, LP — 3 Lakes Dr, Northfield, IL, 60093-2753

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Medline Industries, LP medical devices 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. 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…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10195327210144, 40195327210145, 10193489682069; lot code 23FLA191, 23LBM199, 23KBM369; model number CDS840015AQ, CDS840023T, CDS840087AI. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.

Can I get my money back?

Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.

Where was the recalled product sold?

It was distributed nationwide.

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