The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1849-2026·Announced 2026-04-29

Medline Medical Device Kits Recall for Loss of 510(k) Clearance

Medline Industries is recalling certain surgical and medical kits because their 510(k) regulatory clearances for Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. About 2,609 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Our severity reasoning: The source text states only that regulatory clearances have been rescinded, with no reports of illness, injury, or harm. This is a regulatory/documentation-based recall without evidence of actual patient risk, qualifying as a moderate precautionary recall under FDA Class II classification.

Plain-English summary

Medline Industries, LP is recalling seven models of surgical and medical device kits distributed nationwide. The affected kits include craniotomy packs, extremity packs, radiology packs, and custom packs. These products contain Control Syringes, Guidewires, and/or High-Pressure Tubing components.

The recall was initiated because the 510(k) regulatory clearances for these components have been rescinded. Approximately 2,609 units were affected by this recall.

Customers who have received these kits should contact Medline Industries, LP for instructions on handling the recalled products. The recalled lot numbers and model numbers are detailed in the original FDA notice.

The recalled product

Product
Medline Kits: 1) BWNBORO CRANIOTOMY PACK-LF, Model Number: DYNJ32841F; 2) CRANIOTOMY PACK-LF, Model Number: DYNJ46069D 3) CAMPUS EXTREMITY PK, Model Number: DYNJ51935A 4) FOOT -XRAY BOWL MEDCUP SPECCUP, Model Number: DYNJ68902A 5) RADIOLOGY SPINE PACK, Model Number…
Manufacturer
Medline Industries, LP
Category
Medical Device — Surgical Kits
Hazard
Affected units
2,609

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) DYNJ32841F
  • UDI-DI: 10195327037796(each)
  • 40195327037797(case)
  • Lot Number: 24CBF407
  • 2) DYNJ46069D
  • UDI-DI: 10193489493184(each)
  • 40193489493185(case)
  • Lot Number: 24KBG704
  • 3) DYNJ51935A
  • UDI-DI: 10889942735549(each)
  • 40889942735540(case)
  • Lot Number: 24BME364
  • 4) DYNJ68902A
  • UDI-DI: 10193489870411(each)
  • 40193489870412(case)
  • Lot Number: 24BMC999
  • 5) DYNJ80679A
  • UDI-DI: 10195327273705(each)
  • 40195327273706(case)
  • Lot Number: 22KBJ690

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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