The Recall Desk
Agency classClass IIOur severity:Severity pendingFDA (Devices)·Z-0170-2027·Announced 2026-10-21

Medline surgical convenience kits labeled as: 1) OPEN HEART CDS, Medline product number/SKU CDS84

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
Medline surgical convenience kits labeled as: 1) OPEN HEART CDS, Medline product number/SKU CDS840094R; 2) OPEN HEART CDS, Medline product number/SKU CDS840171AG; 3) MHC AV FISTULA, Medline product number/SKU DYNJ903705K; 4) PERIPHERAL VASC MAJR-LF, Medline product…
Manufacturer
Medline Industries, LP
Category
Medical Device — Devices
Affected units
193,374

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 kit number/SKU CDS840076AD
  • UDI/DI 10198459311536 (each) 40198459311537 (case)
  • Lot Number 26HBD144
  • Medline product kit number/SKU CDS840393P
  • UDI/DI 10198459405266 (each) 40198459405267 (case)
  • Lot Number 26FMA487
  • Medline product kit number/SKU CDS840132RFP
  • UDI/DI 10195327669324 (each) 40195327669325 (case)
  • Lot Number 26FBR713
  • Medline product kit number/SKU DYNJ906775G
  • UDI/DI 10198459506390 (each) 40198459506391 (case)
  • Lot Number 26DMK788
  • Lot Number 26DMG190
  • Lot Number 26DMA855
  • Medline product kit number/SKU DYNJ902765G
  • UDI/DI 10198459161599 (each) 40198459161590 (case)
  • Lot Number 26DBO919
  • Medline product kit number/SKU DYNJ907552B
  • UDI/DI 10195327260750 (each) 40195327260751 (case)
  • Lot Number 26CML345

Distribution

Distributed nationwide across the United States.

Related recalls

Same manufacturer · Medline Industries, LP

See all →