The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-1842-2026·Announced 2026-04-29

Medline Surgical Kits Recalled Due to Rescinded Regulatory Clearances

Medline Industries is recalling 41 different surgical kit models nationwide because regulatory clearances for certain control syringes, guidewires, and high-pressure tubing have been rescinded. Affected facilities should stop use and contact Medline.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class II recall involving medical devices (surgical kits with cleared components now lacking valid regulatory clearance). The kits are used in critical medical procedures and the loss of regulatory clearance for key internal components (control syringes, guidewires, high-pressure tubing) represents a significant device defect affecting multiple patient-critical applications, meeting the Severe threshold.

Plain-English summary

Medline Industries, LP is recalling 41 surgical kit models distributed nationwide. The kits include newborn admission kits, cardiac catheterization packs, neuro packs, pacemaker packs, vascular packs, and various other surgical trays. A total of 38,014 units have been distributed.

The recall has been initiated because the 510(k) regulatory clearances for certain control syringes, guidewires, and/or high-pressure tubing components within these kits have been rescinded. This means these components no longer have valid FDA clearance for use.

Healthcare facilities that have received these kits should stop using them immediately. Facilities should identify affected inventory using the provided model numbers and lot numbers, and contact Medline Industries for instructions on return or replacement. The FDA is asking Medline to notify customers of this recall.

The recalled product

Product
Medline Kits: 1) NEWBORN ADMISSION, Model Number: DYKB1038; 2) DRAINAGE TRAY, Model Number: DYNDA3188; 3) VA ORLANDO SHOULDER PACK, Model Number: DYNJG001027B; 4) TUMESCENT SYRINGE KIT, Model Number: DYNJTUMSYR; 5) OMC PTCA PACK, Model Number: DYNJT3719; 6) PORT PACK…
Manufacturer
Medline Industries, LP
Category
Medical Device — Surgical Kits
Hazard
Affected units
38,014

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) DYKB1038
  • UDI-DI: 10193489502428(each)
  • 40193489502429(case)
  • Lot Number: 22GBJ869
  • 2) DYNDA3188
  • UDI-DI: 10198459303579(each)
  • 40198459303570(case)
  • Lot Number: 25DBF256
  • 3) DYNJG001027B
  • UDI-DI: 10198459065453(each)
  • 40198459065454(case)
  • Lot Number: 25ELA998
  • 4) DYNJG001027B
  • Lot Number: 25ELA723
  • 5) DYNJTUMSYR
  • UDI-DI: 10884389882054(each)
  • 40884389882055(case)
  • Lot Number: 21BBH579
  • 6) DYNJTUMSYR
  • Lot Number: 21BBS213

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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