Medline Industries, LP: Medline Syringes: 1) SYRINGE 12ML CONTROL W/ROTATOR, Model Number: DYNJSYR12CWR; 2) SYRINGE 10ML CONTROL W/ROTATOR, Model Number: DYNJSYR
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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 Syringes: 1) SYRINGE 12ML CONTROL W/ROTATOR, Model Number: DYNJSYR12CWR; 2) SYRINGE 10ML CONTROL W/ROTATOR, Model Number: DYNJSYR10CWR; 3) SYR CONTROL PAD 12ML L/L, Model Number: DYNJSYR12CP; 4) TBG PRESS 72IN M/F ROT BRAID, Model Number: DYNJBRT72R; 5) SYRINGE 10ML CONTROL MLL, Model Number: DYNJSYR10C; 6) SYRINGE 8ML CONTROL MLL, Model Number: DYNJSYR8C; 7) SYRINGE 12ML CONTROL MLL, Model Number: DYNJSYR12C; 8) SYR CONTROL PAD 10ML L/L ROT, Model Number: DYNJSYR10CRP; 9) SYR CONTROL PAD 12ML L/L ROT, Model Number: DYNJSYR12CRP; 10) CTRL SYRINGE 6ML RING ROT L/L, Model Number: DYNJSYRC6CWR
- 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- The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.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) DYNJSYR12CWR, UDI-DI: 10884389676486(each), 40884389676487(case), Lot Number: 25ABF227; 2) DYNJSYR12CWR, UDI-DI: 10884389676486(each), 40884389676487(case), Lot Number: 25CBC537; 3) DYNJSYR12CWR, UDI-DI: 10884389676486(each), 40884389676487(case), Lot Number: 25EBK855; 4) DYNJSYR12CWR, UDI-DI: 10884389676486(each), 40884389676487(case), Lot Number: 25IDA120; 5) DYNJSYR12CWR, UDI-DI: 10884389676486(each), 40884389676487(case), Lot Number: 25IDA552; 6) DYNJSYR12CWR, UDI-DI: 10884389676486(each), 40884389676487(case), Lot Number: 25IDA648; 7) DYNJSYR12CWR, UDI-DI: 10884389676486(each), 40884389676487(case), Lot Number: 25IDB507; 8) DYNJSYR10CWR, UDI-DI: 10884389672723(each), 40884389672724(case), Lot Number: 25EBH091; 9) DYNJSYR10CWR, UDI-DI: 10884389672723(each), 40884389672724(case), Lot Number: 25EBO178; 10) DYNJSYR10CWR, UDI-DI: 10884389672723(each), 40884389672724(case), Lot Number: 25IDA686; 11) DYNJSYR10CWR, UDI-DI: 10884389672723(each), 40884389672724(case), Lot Number: 25JDA207; 12) DYNJSYR10CWR, UDI-DI: 10884389672723(each), 40884389672724(case), Lot Number: 25JDB599; 13) DYNJSYR12CP, UDI-DI: 10888277236615(each), 40888277236616(case), Lot Number: 25GBD528; 14) DYNJSYR12CP, UDI-DI: 10888277236615(each), 40888277236616(case), Lot Number: 25JDB601; 15) DYNJBRT72R, UDI-DI: 10884389854211(each), 40884389854212(case), Lot Number: 25GBN402; 16) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 25GBS345; 17) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 25GBS857; 18) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 25GBU045; 19) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 25GBV139; 20) DYNJSYR8C, UDI-DI: 10884389676493(each), 40884389676494(case), Lot Number: 25IDB505; 21) DYNJSYR12C, UDI-DI: 10884389676479(each), 40884389676470(case), Lot Number: 25IDB506; 22) DYNJSYR12C, UDI-DI: 10884389676479(each), 40884389676470(case), Lot Number: 25JDA208; 23) DYNJSYR12C, UDI-DI: 10884389676479(each), 40884389676470(case), Lot Number: 25JDB827; 24) DYNJSYR10CRP, UDI-DI: 10888277236585(each), 40888277236586(case), Lot Number: 25JDA594; 25) DYNJSYR12CRP, UDI-DI: 10888277236592(each), 40888277236593(case), Lot Number: 25JDB600; 26) DYNJSYRC6CWR, UDI-DI: 10889942885732(each), 40889942885733(case), Lot Number: 25JDB602
- Product quantity
- 38,230 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Northfield
- State
- IL
- Country
- United States
- Event id
- 98599
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