Medline Control Syringes, Guidewires, and High-Pressure Tubing 510(k) Rescinded
Medline Industries has recalled multiple control syringes, guidewires, and high-pressure tubing models because their FDA 510(k) regulatory clearances have been rescinded. The recall affects 38,230 units 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall. The source text provides no evidence of illness, injury, or reported harm; the hazard is regulatory (rescission of 510(k) clearance) rather than a documented safety defect. The recall appears precautionary in nature.
Plain-English summary
Medline Industries, LP is recalling certain Control Syringes, Guidewires, and High-Pressure Tubing products. The 510(k) regulatory clearances for these devices have been rescinded by the FDA.
Affected products include multiple syringe models (DYNJSYR12CWR, DYNJSYR10CWR, DYNJSYR12CP, DYNJSYR10C, DYNJSYR8C, DYNJSYR12C, DYNJSYR10CRP, DYNJSYR12CRP, DYNJSYRC6CWR), tubing (DYNJBRT72R), and guidewires distributed nationwide. A total of 38,230 units are involved, with specific lot numbers identified in the recall notice.
Customers who have received these products should discontinue use and contact Medline Industries for further instructions regarding return or replacement of the affected devices.
The recalled product
- 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…
- Manufacturer
- Medline Industries, LP
- Affected units
- 38,230
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) DYNJSYR12CWR
- UDI-DI: 10884389676486(each)
- 40884389676487(case)
- Lot Number: 25ABF227
- 2) DYNJSYR12CWR
- Lot Number: 25CBC537
- 3) DYNJSYR12CWR
- Lot Number: 25EBK855
- 4) DYNJSYR12CWR
- Lot Number: 25IDA120
- 5) DYNJSYR12CWR
- Lot Number: 25IDA552
- 6) DYNJSYR12CWR
- Lot Number: 25IDA648
- 7) DYNJSYR12CWR
- Lot Number: 25IDB507
- 8) DYNJSYR10CWR
- UDI-DI: 10884389672723(each)
- 40884389672724(case)
- Lot Number: 25EBH091
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.
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