The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-1843-2026·Announced 2026-04-29

Control Syringes and Related Devices FDA Regulatory Clearances Rescinded

Medline Industries has recalled Control Syringes (Model DNSC89369 and DYNJSYR10C), Guidewires, and High-Pressure Tubing after their FDA 510(k) regulatory clearances were rescinded. The devices 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 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Our severity reasoning: The recall involves medical devices with rescinded FDA 510(k) clearances, which indicates loss of regulatory authorization for marketing. This is an FDA Class II recall affecting a large number of units (198,210) distributed nationwide, meeting the threshold for Severe severity.

Plain-English summary

Medline Industries, LP is recalling Control Syringes (Model DNSC89369: 8ML ROTATING and Model DYNJSYR10C: 10ML CONTROL), along with associated Guidewires and High-Pressure Tubing. The FDA has rescinded the 510(k) regulatory clearances for these devices, affecting 198,210 units distributed nationwide.

Affected lot numbers for the 8ML ROTATING model include DNSC89369 (Lot 25BDB731). The 10ML CONTROL model has 61 affected lot numbers ranging from 21ABS242 through 25GBK401. Consumers and healthcare facilities currently using or possessing these recalled devices should contact Medline Industries or the FDA for further instructions on proper handling and return procedures.

The recalled product

Product
Medline Kits: 1) SYR CONTROL 8ML ROTATING, Model Number: DNSC89369; 2) SYRINGE 10ML CONTROL MLL, Model Number: DYNJSYR10C
Manufacturer
Medline Industries, LP
Category
Medical Device — Syringes and Related Injection Devices
Hazard
Affected units
198,210

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) DNSC89369
  • UDI-DI: 10889942596225(each)
  • 40889942596226(case)
  • Lot Number: 25BDB731
  • 2) DYNJSYR10C
  • UDI-DI: 10884389676462(each)
  • 40884389676463(case)
  • Lot Number: 21BBM369
  • 3) DYNJSYR10C
  • Lot Number: 21DBO183
  • 4) DYNJSYR10C
  • Lot Number: 21DBY321
  • 5) DYNJSYR10C
  • Lot Number: 21FBC554
  • 6) DYNJSYR10C
  • Lot Number: 21FBJ020
  • 7) DYNJSYR10C
  • Lot Number: 21FBU555
  • 8) DYNJSYR10C
  • Lot Number: 21KBN994

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 →

Related recalls

Same manufacturer · Medline Industries, LP

See all →

Same hazard · regulatory clearance rescission

See all →

Similar recalls