Class II U.S. Food and Drug Administration

Medline surgical convenience kits labeled as: 1) Open Heart Pack A &#38 recall: Medical convenience kits were distributed containing cannula components

Recall published 7 days ago

Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-0176-2027
Published
October 21, 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
36199 kits
Distribution
Nationwide
Made in
United States
Lot / code info
Medline product number/SKU DYNJ04584L, UDI/DI 10198459212291 (each) 40198459212292 (case), Lot number 26DMA968; Medline product number/SKU DYNJT5715A, UDI/DI 10198459505126 (each) 40198459505127 (case), Lot number 26CMI506; Medline product number/SKU DYNJ85751, UDI/DI 10195327542917 (each) 40195327542918 (case), Lot number 26BMB785; Medline product number/SKU DYNJ53741N, UDI/DI 10198459560088 (each) 40198459560089 (case), Lot number 26BBG793; Medline product number/SKU DYNJ80701A, UDI/DI 10198459026195 (each) 40198459026196 (case), Lot number 26BBF945; Medline product number/SKU DYNJ67308C, UDI/DI 10198459676666 (each) 40198459676667 (case), Lot number 26BBF661; Medline product number/SKU DYNJ89451B, UDI/DI 10198459637674 (each) 40198459637675 (case), Lot number 26BBC903; Medline product number/SKU DYNJ42166A, UDI/DI 10888277938281 (each) 40888277938282 (case), Lot number 26BBB320; Medline product number/SKU DYNJ67363C, UDI/DI 10198459652226 (each) 40198459652227 (case), Lot number 26AML066; Medline product number/SKU DYNJ67363B, UDI/DI 10198459259081 (each) 40198459259082 (case), Lot number 26AMK067; Medline product number/SKU DYNJ65779B, UDI/DI 10195327571733 (each) 40195327571734 (case), Lot number 26AMI446; Medline product number/SKU DYNJ47661J, UDI/DI 10198459525704 (each) 40198459525705 (case), Lot number 26AMF686; Medline product number/SKU DYNJ04584L, UDI/DI 10198459212291 (each) 40198459212292 (case), Lot number 26AMF245; Medline product number/SKU DYNJ04470L, UDI/DI 10198459548031 (each) 40198459548032 (case), Lot number 26AME079; Medline product number/SKU DYNJ44647D, UDI/DI 10198459615085 (each) 40198459615086 (case), Lot number 26AMC530; Medline product number/SKU DYNJ0660029AM, UDI/DI 10198459486296 (each) 40198459486297 (case), Lot number 26AMA935; Medline product number/SKU DYNJ0160327C, UDI/DI 10195327320065 (each) 40195327320066 (case), Lot number 26ADA892; Medline product number/SKU DYNJ60819L, UDI/DI 10198459536113 (each) 40198459536114 (case), Lot number 26ABW172; Medline product number/SKU DYNJ0271227R, UDI/DI 10198459591846 (each) 40198459591847 (case), Lot number 26ABU969; Medline product number/SKU DYNJ81541C, UDI/DI 10198459082832 (each) 40198459082833 (case), Lot number 26ABS893; Medline product number/SKU DYNJ54094F, UDI/DI 10198459286247 (each) 40198459286248 (case), Lot number 26ABR346; Medline product number/SKU DYNJ62055C, UDI/DI 10198459591914 (each) 40198459591915 (case), Lot number 26ABQ526; Medline product number/SKU DYNJ49366, UDI/DI 10888277847583 (each) 40888277847584 (case), Lot number 26ABQ367; Medline product number/SKU DYNJ65416D, UDI/DI 10198459117404 (each) 40198459117405 (case), Lot number 26ABO155; Medline product number/SKU DYNJ908879G, UDI/DI 10198459377419 (each) 40198459377410 (case), Lot number 26ABN783; Medline product number/SKU DYNJ81096B, UDI/DI 10195327590673 (each) 40195327590674 (case), Lot number 26ABM969; Medline product number/SKU DYNJ53741N, UDI/DI 10198459560088 (each) 40198459560089 (case), Lot number 26ABM155; Medline product number/SKU DYNJ54732I, UDI/DI 10195327549664 (each) 40195327549665 (case), Lot number 26ABK432; Medline product number/SKU DYNJ62691F, UDI/DI 10198459501364 (each) 40198459501365 (case), Lot number 26ABK423; Medline product number/SKU DYNJ54734I, UDI/DI 10195327549565 (each) 40195327549566 (case), Lot number 26ABI561; Medline product number/SKU DYNJ42166A, UDI/DI 10888277938281 (each) 40888277938282 (case), Lot number 26ABG526; Medline product number/SKU DYNJ54734I, UDI/DI 10195327549565 (each) 40195327549566 (case), Lot number 26ABD862; Medline product number/SKU DYNJ903745I, UDI/DI 10198459302800 (each) 40198459302801 (case), Lot number 26ABC126; Medline product number/SKU DYNJ21812O, UDI/DI 10198459174483 (each) 40198459174484 (case), Lot number 26ABB509; Medline product number/SKU DYNJ82955C, UDI/DI 10198459496141 (each) 40198459496142 (case), Lot number 25LMH836; Medline product number/SKU DYNJ0199156Y, UDI/DI 10198459570674 (each) 40…
UPC codes
10198459212291, 40198459212292, 10198459505126, 40198459505127, 10195327542917, 40195327542918, 10198459560088, 40198459560089, 10198459026195, 40198459026196, 10198459676666, 40198459676667, 10198459637674, 40198459637675, 10888277938281, 40888277938282, 10198459652226, 40198459652227, 10198459259081, 40198459259082

Products covered by this recall

Medline surgical convenience kits labeled as: 1) OPEN HEART PACK A & B, Medline Product number/SKU DYNJ04584L; 2) OPEN HEART ACCESSORY PACK, Medline Product number/SKU DYNJT5715A; 3) CABG ACCESSORY PACK, Medline Product number/SKU DYNJ85751; 4) OPEN HEART PACK, Medline Product number/SKU DYNJ53741N; 5) OPEN HEART PACK 1&2, Medline Product number/SKU DYNJ80701A; 6) VEIN PACK, Medline Product number/SKU DYNJ67308C; 7) OPEN HEART PACK, Medline Product number/SKU DYNJ89451B; 8) VASCULAR TRAY-LF, Medline Product number/SKU DYNJ42166A; 9) ENDOSCOPIC VEIN HARVEST PK, Medline Product number/SKU DYNJ67363C; 10) ENDOSCOPIC VEIN HARVEST PK, Medline Product number/SKU DYNJ67363B; 11) LIVER TRANSPLANT PACK B, Medline Product number/SKU DYNJ65779B; 12) CABG PACK-LF, Medline Product number/SKU DYNJ47661J; 13) VEIN HARVEST PACK, Medline Product number/SKU DYNJ04470L; 14) CARDIAC PACK, Medline Product number/SKU DYNJ44647D; 15) GM OPEN HEART ACC PACK-LF, Medline Product number/SKU DYNJ0660029AM; 16) CARDIOVASCULAR PACK-LF, Medline Product number/SKU DYNJ0160327C; 17) GOOD SHEPHERD OPEN HEART, Medline Product number/SKU DYNJ60819L; 18) OPEN HEART PACK, Medline Product number/SKU DYNJ0271227R; 19) OPEN HEART PACK, Medline Product number/SKU DYNJ81541C; 20) TAVR PACK, Medline Product number/SKU DYNJ54094F; 21) TRANSPLANT BACKTABLE PACK, Medline Product number/SKU DYNJ62055C; 22) VASCULAR, Medline Product number/SKU DYNJ49366; 23) BACK TABLE TRAY, Medline Product number/SKU DYNJ65416D; 24) CV PART 1 AND 2, Medline Product number/SKU DYNJ908879G; 25) OPEN HEART A B PACK, Medline Product number/SKU DYNJ81096B; 26) KIDNEY, Medline Product number/SKU DYNJ54732I; 27) ABDOMINAL PRESEVERVATION PACK, Medline Product number/SKU DYNJ62691F; 28) LIVER PACK SAFETY, Medline Product number/SKU DYNJ54734I; 29) CV PROCEDURE PART A, Medline Product number/SKU DYNJ903745I;

Check your product

The notice names 60 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.

  • 10198459212291
  • 40198459212292
  • 10198459505126
  • 40198459505127
  • 10195327542917
  • 40195327542918
  • 10198459560088
  • 40198459560089
  • 10198459026195
  • 40198459026196
  • 10198459676666
  • 40198459676667
  • 10198459637674
  • 40198459637675
  • 10888277938281
  • 40888277938282
  • 10198459652226
  • 40198459652227
  • 10198459259081
  • 40198459259082

Lot or batch code

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

  • 26DMA968
  • 26CMI506
  • 26BMB785
  • 26BBG793
  • 26BBF945
  • 26BBF661
  • 26BBC903
  • 26BBB320
  • 26AML066
  • 26AMK067
  • 26AMI446
  • 26AMF686
  • 26AMF245
  • 26AME079
  • 26AMC530
  • 26AMA935
  • 26ADA892
  • 26ABW172
  • 26ABU969
  • 26ABS893

Model or item number

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

  • DYNJ04584L
  • DYNJT5715A
  • DYNJ85751
  • DYNJ53741N
  • DYNJ80701A
  • DYNJ67308C
  • DYNJ89451B
  • DYNJ42166A
  • DYNJ67363C
  • DYNJ67363B
  • DYNJ65779B
  • DYNJ47661J
  • DYNJ04470L
  • DYNJ44647D
  • DYNJ0660029AM
  • DYNJ0160327C
  • DYNJ60819L
  • DYNJ0271227R
  • DYNJ81541C
  • DYNJ54094F

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 Device

Medline Industries, LP — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  3. Ask the supplier or clinic that provided it what the remedy is in your case.
  4. If you are a facility, quarantine affected stock and log the correction.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

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?

Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use. Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10198459212291, 40198459212292, 10198459505126; lot code 26DMA968, 26CMI506, 26BMB785; model number DYNJ04584L, DYNJT5715A, DYNJ85751. 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?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Where was the recalled product sold?

It was distributed nationwide.

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