CLASS II ONGOING Device recall · Reported 29 Apr 2026 · FDA Enforcement Report

Medline Syringes: Syringe Control W/Rotator recalled

Medline Industries is recalling Medline Syringes: Syringe Control W/Rotator, distributed nationwide in the US. The recall was initiated on 25 Feb 2026 and the FDA has classified it as Class II.

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Lot, batch or date codes1) 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

Quantity recalled38,230 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1831-2026
FDA event ID: 98599
Recalling firm: Medline Industries, Northfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 25 Feb 2026
FDA classified: 17 Apr 2026
Reported: 29 Apr 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Syringes & Needles

Timeline

25 Feb 2026	Recall initiated by company
17 Apr 2026	Classified by FDA	+51 days
29 Apr 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Product as listed by the FDA

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

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Is Medline Syringes: Syringe Control W/Rotator recalled?

Yes. Medline Industries recalled Medline Syringes: Syringe Control W/Rotator on 25 Feb 2026. The recall is Class II and its status is Ongoing. Recall number Z-1831-2026.

Why was it recalled?

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Which lots are affected?

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

Where was it sold?

US Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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