Medline Convenience Kits with Polycarbonate Syringes Unapproved Design Changes
Medline Industries is recalling select 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: This is an FDA Class II recall for design changes made outside 510(k) clearance. The source text does not report any illnesses, injuries, or deaths, making this a voluntary/precautionary regulatory compliance issue rather than a direct safety hazard with reported harm.
Plain-English summary
Medline Industries, LP is recalling Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes. The products include multiple kit types: Bariatric, General Laparoscopy Pack, Laparoscopy, Laparotomy Pack, Major Lithotomy Pack, Major Plus Pack, and Minor General Pack, with various model numbers listed (DYNJ905153M, DYNJ905153N, DYNJ81602, DYNJ905157K, DYNJ905157L, DYNJ46675G, DYNJ81607, DYNJ905160O, and DYNJ81599).
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. A total of 270,311 units are affected.
The products have been distributed nationwide in the United States and to Canada, Panama, and Barbados. Affected lot numbers are specified in FDA recall number Z-1881-2026. Healthcare facilities and individuals who have received these kits should contact Medline Industries, LP for instructions on return or replacement. The FDA classified this as a Class II recall.
The recalled product
- Product
- Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BARIATRIC DYNJ905153M, DYNJ905153N GENERAL LAPAROSCOPY PACK DYNJ81602 LAPAROSCOPY DYNJ905157K, DYNJ905157L LAPAROTOMY PACK DYNJ46675G MAJOR LITHOTOMY PACK DYNJ81607…
- Manufacturer
- Medline Industries, LP
- Hazard
- 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 (2)
- DYNJ905153N lots 24HMG087 24IMA442 24IMG245
- DYNJ905157K lots 23LME674 24AMH261 24AMJ205 24BME886 24CMD057
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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