Medline Convenience Kits with Syringes Recalled for Unapproved Design Changes
Medline Industries, LP is recalling Medline Convenience Kits containing 10mL Polycarbonate Colored Syringes due to unapproved design changes made outside of FDA 510(k) clearance. The recall affects approximately 270,311 units distributed worldwide.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving medical devices (syringes used in clinical procedures like biopsies and drainage) with unapproved design changes outside cleared specifications. The potential for use of non-validated devices in clinical settings without proper FDA oversight meets the Severe criterion for Class II recalls involving significant risk to patient safety.
Plain-English summary
Medline Industries, LP is recalling Medline Convenience Kits that contain select SKUs of 10mL Polycarbonate Colored Syringes, including Biopsy Pack models (DYNJ38587A, DYNJ38587B), Biopsy/Drainage Tray-LF (DYNJ30078D), and W LINQ Pack (DYNJ59108B). The recall was initiated because the products were subject to unapproved design changes that were made outside of the 510(k) clearance scope.
The recalled kits have been distributed worldwide, including throughout the United States, Canada, Panama, and Barbados. Approximately 270,311 units are affected. Specific lot numbers are identified in the recall notice for each SKU.
Consumers and healthcare facilities that have received these products should stop use and contact Medline Industries, LP for further instructions regarding return or replacement of the affected kits. Healthcare providers should verify that the syringes in their Medline Convenience Kits match the recalled lot numbers and SKUs listed in the recall notice.
The recalled product
- Product
- Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BIOPSY PACK DYNJ38587A, DYNJ38587B BIOPSY/DRAINAGE TRAY-LF DYNJ30078D W LINQ PACK DYNJ59108B
- Manufacturer
- Medline Industries, LP
- 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)
- DYNJ38587B Lots 25BMB873
- DYNJ59108B Lots 24LBT539
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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