RecallRadar

FDA Device recall Z-1843-2026

Medline Kits: 1) SYR CONTROL 8ML ROTATING, Model Number: DNSC89369

On 2026-04-29 the FDA classified a Class II recall of Medline Kits: 1) SYR CONTROL 8ML ROTATING, Model Number: DNSC89369 by Medline Industries, citing the 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1843-2026
ClassificationClass II
Statusongoing
Initiated2026-02-25
Published2026-04-29
Last updated2026-09-13 11:58 UTC
CompanyMedline Industries
DistributionUS

Product

Medline Kits: 1) SYR CONTROL 8ML ROTATING, Model Number: DNSC89369; 2) SYRINGE 10ML CONTROL MLL, Model Number: DYNJSYR10C

Reason

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Identifiers

code_info
1) DNSC89369, UDI-DI: 10889942596225(each), 40889942596226(case), Lot Number: 25BDB731; 2) DYNJSYR10C, UDI-DI: 10884389…1) DNSC89369, UDI-DI: 10889942596225(each), 40889942596226(case), Lot Number: 25BDB731; 2) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 21BBM369; 3) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 21DBO183; 4) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 21DBY321; 5) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 21FBC554; 6) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 21FBJ020; 7) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 21FBU555; 8) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 21KBN994; 9) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 21KBV737; 10) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 22ABI338; 11) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 22DBT508; 12) DYNJSYR10C, UDI-

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1843-2026%22

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