Medline 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 clearance. The recall affects 270,311 units distributed nationwide and internationally.
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 unapproved design changes to medical devices. The source text does not report any illnesses, injuries, or deaths, and the hazard is regulatory non-compliance rather than an acute safety threat. Under the rubric, Class II recalls without hospitalization reports typically score 2.
Plain-English summary
Medline Industries, LP is recalling Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes, specifically the Face/Rhinoplasty Pack (DYNJ80343C) and Plastic Head-Neck Pack (DYNJ86639). The reason for the recall is that unapproved design changes were made to the products outside of the 510(k) clearance granted by the FDA.
The affected kits total 270,311 units and have been distributed worldwide, including US Nationwide distribution as well as shipments to Canada, Panama, and Barbados. The affected lot numbers are 24ABO127 (DYNJ80343C) and 24FBM972 (DYNJ86639).
Customers who have received these kits should stop using them and contact Medline Industries for instructions on return or replacement.
The recalled product
- Product
- Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes FACE/RHINOPLASTY PACK DYNJ80343C PLASTIC HEAD-NECK PACK DYNJ86639
- Manufacturer
- Medline Industries, LP
- 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.
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