Medline Convenience Kits with Polycarbonate Syringes 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 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: FDA Class II recall for unapproved design changes. No reported injuries or illnesses are documented in the source text, and the hazard is regulatory non-compliance rather than an identified safety defect, placing this in the Moderate category.
Plain-English summary
Medline Industries, LP is recalling Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes (Arthroscopy Pack, model DYNJ45173D). The products have undergone design changes that were not approved through the FDA 510(k) clearance process.
The affected products have been distributed worldwide, including nationwide in the United States and internationally in Canada, Panama, and Barbados. The recall involves lot 24BBB811 with a total of 270,311 units.
Patients and healthcare providers who have these products should stop using them and contact Medline Industries for instructions on return or replacement. Healthcare facilities should verify whether they have received affected units and quarantine them pending further guidance.
The recalled product
- Product
- Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ARTHROSCOPY PACK DYNJ45173D
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Syringes
- Affected units
- 270,311
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 (1)
- DYNJ45173D UDI-DI 10889942485222 (EA) 40889942485223 (CS) LOT 24BBB811
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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