Medline 10mL Polycarbonate Colored Syringes Kits Recalled for Unapproved Design Changes
Medline Industries is recalling Convenience Kits containing 10mL Polycarbonate Colored Syringes due to unapproved design changes made outside of FDA 510(k) clearance. The recall affects syringes distributed worldwide, including the US, Canada, Panama, and Barbados.
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: The source text identifies this as an FDA Class II recall involving unapproved design changes outside 510(k) clearance. There is no evidence in the source of reported illness, injury, or hospitalization. The recall is based on regulatory non-compliance rather than demonstrated patient harm.
Plain-English summary
Medline Industries, LP is recalling Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes. The kits include GU DAVINCI PACK (model DYNJ909398A) and ROBOTIC PACK (model DYNJ908706D) configurations. A total of 270,311 units have been distributed worldwide, including across the United States, Canada, Panama, and Barbados.
The recall was initiated because unapproved design changes were made to these products outside of the scope of their 510(k) clearance. This means modifications to the syringes were implemented without prior FDA approval or clearance.
Affected lot numbers include: for DYNJ909398A — lots 23EMF078, 23HME512, 23HMI269, 23JMB528, 23KME175, 24EMC327, 24GMH510, and 24HMG886; for DYNJ908706D — lots 24HMA783, 24HMG308, 24KMC651, 24KMJ274, 24LME931, 25AME217, and 25BMI653. Healthcare facilities and other users in possession of these lots should discontinue use and contact Medline Industries, LP for instructions on return or replacement.
The recalled product
- Product
- Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes GU DAVINCI PACK - LF DYNJ909398A ROBOTIC PACK DYNJ908706D
- Manufacturer
- Medline Industries, LP
- Hazard
- Affected units
- 270,311
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 17 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.
See all 17 products in this recall →Related recalls
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