The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1833-2026·Announced 2026-04-29

Medline Medical Device Kits With Rescinded FDA Clearances

FDA has rescinded the 510(k) clearances for certain Medline medical device kits including control syringes, guidewires, and high-pressure tubing. Medline is recalling approximately 58,836 units distributed nationwide.

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

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall. The source text provides no reports of illnesses, injuries, or adverse events. The recall is based on regulatory clearance withdrawal, which constitutes a precautionary recall action without reported harm.

Plain-English summary

Medline Industries, LP is recalling three medical device kit products: the SYR CNTRL 10ML RING W/ROT NB (Model DYNJSYR10CWRB), MANIFOLD KIT LOW PRESSURE OFF (Model VASCSLPOFF1), and EP MANIFOLD KIT (Model VASC1018A). The FDA has rescinded the 510(k) regulatory clearances for these devices, which include control syringes, guidewires, and/or high-pressure tubing.

The affected products were distributed nationwide to medical facilities and healthcare providers. A total of 58,836 units are involved in this recall, spanning multiple lot numbers across the three product models.

Healthcare facilities and practitioners who have these devices should discontinue use and contact Medline Industries regarding device return or replacement options. Patients with questions about the use of these devices should contact their healthcare provider.

The recalled product

Product
Medline Kits: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB; 2) MANIFOLD KIT LOW PRESSURE OFF, Model Number: VASCSLPOFF1; 3) EP MANIFOLD KIT, Model Number: VASC1018A
Manufacturer
Medline Industries, LP
Category
Medical Device — Cardiovascular / Vascular Access
Hazard
Affected units
58,836

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)

  • 1) DYNJSYR10CWRB
  • UDI-DI: 10889942540570(each)
  • 40889942540571(case)
  • Lot Number: 22IBH073
  • 2) DYNJSYR10CWRB
  • Lot Number: 22IBH620
  • 3) DYNJSYR10CWRB
  • Lot Number: 22KBU236
  • 4) DYNJSYR10CWRB
  • Lot Number: 22LBB186
  • 5) DYNJSYR10CWRB
  • Lot Number: 23BBE163
  • 6) DYNJSYR10CWRB
  • Lot Number: 23BBQ244
  • 7) DYNJSYR10CWRB
  • Lot Number: 23BBT094
  • 8) DYNJSYR10CWRB
  • Lot Number: 23CBN156
  • 9) DYNJSYR10CWRB
  • Lot Number: 23DBO047

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 22 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 22 products in this recall →

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