Medline Namic Control Syringes recalled due to rescinded FDA clearance
Medline Industries is recalling Medline Namic Control Syringes (Model DYNJSYR10CWRB) because the FDA has rescinded their 510(k) regulatory clearance. The recall affects 24,170 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 involving rescission of regulatory clearance for a medical device. The source text does not report any injuries, illnesses, or adverse events associated with these syringes, making this a regulatory/compliance issue rather than an immediate safety hazard to patients.
Plain-English summary
Medline Industries, LP is recalling Medline Namic Control Syringes, Model Number DYNJSYR10CWRB, due to rescission of their 510(k) regulatory clearances by the FDA. Approximately 24,170 units have been distributed nationwide.
The recall involves five affected lot numbers: 25GBK394, 25GBN659, 25GBO446, 25GBO586, and 25GBQ523. All units have the UDI-DI 10889942540570 (individual) and 40889942540571 (case).
Healthcare facilities and providers who have received these syringes should stop using them and contact Medline Industries for instructions on return or disposal. Patients who may have been affected should consult their healthcare provider with any concerns.
The recalled product
- Product
- Medline Namic Syringes: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB;
- Manufacturer
- Medline Industries, LP
- Affected units
- 24,170
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 (12)
- 1) DYNJSYR10CWRB
- UDI-DI: 10889942540570(each)
- 40889942540571(case)
- Lot Number: 25GBK394
- 2) DYNJSYR10CWRB
- Lot Number: 25GBN659
- 3) DYNJSYR10CWRB
- Lot Number: 25GBO446
- 4) DYNJSYR10CWRB
- Lot Number: 25GBO586
- 5) DYNJSYR10CWRB
- Lot Number: 25GBQ523
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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