The Recall Desk
Agency classClass IIOur severity:Severity pendingFDA (Devices)·Z-0169-2027·Announced 2026-10-21

1) Product Name AUD OPEN HEART PACK, Medline Kit Number/SKU DYNJ22052I; 2) Product Name AV SHUNT P

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 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

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English summary

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 recalled product

Product
1) Product Name AUD OPEN HEART PACK, Medline Kit Number/SKU DYNJ22052I; 2) Product Name AV SHUNT PACK-MARYVIEW, Medline Kit Number/SKU DYNJ24528N; 3) Product Name AV SHUNT PACK-MARYVIEW, Medline Kit Number/SKU DYNJ24528O; 4) Product Name AV SHUNT PACK-MARYVIEW, Medline Kit…
Manufacturer
Medline Industries, LP
Category
Medical Device — Devices
Affected units
1,834

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)

  • Medline product number/SKU DYNJ911589A
  • UDI/DI 10198459646102 (each) 40198459646103 (case)
  • Lot Number 26CBD487
  • Medline product number/SKU DYNJ911710
  • UDI/DI 10198459515705 (each) 40198459515706 (case)
  • Lot Number 26BLA622
  • Medline product number/SKU DYNJ35312K
  • UDI/DI 10198459311574 (each) 40198459311575 (case)
  • Lot Number 26ADA368
  • Medline product number/SKU DYNJT7607
  • UDI/DI 10198459639470 (each) 40198459639471 (case)
  • Lot Number 26ABP608
  • Lot Number 25KLA755
  • Lot Number 25KDA055
  • Lot Number 25JLA081
  • Medline product number/SKU DYNJ80549D
  • UDI/DI 10198459389610 (each) 40198459389611 (case)
  • Lot Number 25JBQ932
  • Lot Number 25IDA242
  • Lot Number 25HBV035

Distribution

Distributed nationwide across the United States.

Related recalls

Same manufacturer · Medline Industries, LP

See all →