The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1829-2026·Announced 2026-04-29

Medline Namic Guidewires Recall Due to Rescinded FDA Clearance

Medline Industries has issued a recall of Medline Namic Guidewires because their FDA 510(k) regulatory clearances have been rescinded. The affected units were 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 involving rescission of regulatory clearances. The source text states no illnesses or injuries have been reported, and the hazard is administrative (loss of clearance) rather than a safety defect with known adverse health consequences, making this a precautionary recall classified as Moderate.

Plain-English summary

Medline Industries, LP is recalling multiple models of Medline Namic Guidewires nationwide. The recall affects 74,085 units across 30 different product models, including various configurations of the GUIDEWIRE 3MMJ and GWIRE HYDRO product lines in 0.035 and 0.038 gauge sizes.

The guidewires are being recalled because their 510(k) regulatory clearances from the FDA have been rescinded. This means the devices no longer have approval to be marketed in the United States.

Healthcare facilities and practitioners who have these guidewires in stock should stop using them and consult with Medline Industries for further instructions regarding the affected lot numbers and model numbers listed in the recall details.

The recalled product

Product
Medline Namic Guidewires: 1) GUIDEWIRE 3MMJ 0.035X260CM LT, Model Number: DYNJGWIRE20L; 2) GWIRE HYDRO 0.035 180CM ANG S, Model Number: DYNJHWIRE105; 3) GWIRE HYDRO 0.035 260CM ANG S, Model Number: DYNJHWIRE107; 4) GWIRE HYDRO 0.035 260CM STR S, Model Number…
Manufacturer
Medline Industries, LP
Category
Medical Device — Guidewires
Hazard
Affected units
74,085

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) DYNJGWIRE20L
  • UDI-DI: 10195327188955(each)
  • 40195327188956(case)
  • Lot Number: 34125030001
  • 2) DYNJGWIRE20L
  • Lot Number: 34125040001
  • 3) DYNJGWIRE20L
  • Lot Number: 25DBG562
  • 4) DYNJGWIRE20L
  • Lot Number: 25DBM956
  • 5) DYNJHWIRE105
  • UDI-DI: 10195327301637(each)
  • 40195327301638(case)
  • Lot Number: 34124110001
  • 6) DYNJHWIRE105
  • Lot Number: 24LBR925
  • 7) DYNJHWIRE105
  • Lot Number: 25IDB410
  • 8) DYNJHWIRE107
  • UDI-DI: 10195327302184(each)

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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