Medline Industries, LP: Medline Kits: 1) SYR CONTROL 8ML ROTATING, Model Number: DNSC89369; 2) SYRINGE 10ML CONTROL MLL, Model Number: DYNJSYR10C
Read the official notice at FDA (device) →
Get alerts for Medline Industries
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Medline Industries, LP
- Product
- Medline Kits: 1) SYR CONTROL 8ML ROTATING, Model Number: DNSC89369; 2) SYRINGE 10ML CONTROL MLL, Model Number: DYNJSYR10C
- Reason / hazard
- The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution.
- Recall initiated
- 2026-02-25
- Code info
- 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-DI: 10884389676462(each), 40884389676463(case), Lot Number: 22EBK614; 13) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 22IBH075; 14) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 22IBH622; 15) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 22IBU135; 16) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 22JBN943; 17) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 22LBO542; 18) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 22OBA220; 19) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 22OBG844; 20) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 23DBO855; 21) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 23FBM361; 22) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 23HBF967; 23) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 23HBM037; 24) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 23HBM038; 25) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 23HBZ420; 26) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 23IBD522; 27) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 23KBQ419; 28) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 24BBB469; 29) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 24EBT832; 30) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 24EBU578; 31) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 24EBV379; 32) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 24GBC953; 33) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 24GBK311; 34) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 24GBP361; 35) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 24GBQ243; 36) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 24GBV309; 37) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 24HBQ322; 38) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 24IBV756; 39) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 24KBF922; 40) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 24LBL381; 41) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 25ABI838; 42) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 25ABN037; 43) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 25ABO304; 44) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 25ABP830; 45) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 25BBA706; 46) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 25BBO573; 47) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 25CBQ928; 48) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 25EBC625; 49) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 25EBG123; 50) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 25EBJ932; 51) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 25EBN364; 52) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 25EBO179; 53) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 25EBQ230; 54) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 25EBT991; 55) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 25GBK401; 56) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 21ABS242; 57) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 22CBV056; 58) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 23DBH886; 59) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 24EBT833; 60) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 24HBV692; 61) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 25CBR555; 62) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 25JDB828
- Product quantity
- 198210 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Northfield
- State
- IL
- Country
- United States
- Event id
- 98599
Free daily digest + "My products" watchlist