Medline convenience kits recalled over unapproved syringe design changes
Medline is recalling convenience kits containing select 10 mL polycarbonate colored syringes because of unapproved design changes made outside the 510(k) clearance. 270,311 units are affected.
What this means for you
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 arising from a regulatory clearance deviation with no product defect or hazard described in the source, which fits the precautionary Moderate band.
Plain-English summary
Medline is recalling convenience kits containing select SKUs of 10 mL polycarbonate colored syringes, including BASIC CL PACK-LF (DYNJ87052), BASIC PACK (DYNJ83976), BASIC SET UP PACK (DYNJ80700) and coronary angiography packs, with the full list in the recall notice. The action covers 270,311 units.
The recall is because of unapproved design changes to the products made outside of the 510(k) clearance. The FDA classified the action as Class II. The source does not describe any defect or hazard arising from the changes.
Distribution was worldwide, covering the United States nationwide and Canada, Panama and Barbados. The kits are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected kits using the SKUs, UDI-DI codes and lot numbers in the recall notice and follow the instructions issued by Medline.
The recalled product
- Product
- Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BASIC CL PACK-LF DYNJ87052 BASIC PACK DYNJ83976 BASIC SET UP PACK DYNJ80700 CORONARY ANGI
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Procedure kit
- 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 (4)
- DYNJ41941D lots 24LBU189 25EBO278
- DYNJ44139C lots 21ABF720 21BBP639 21OBA387 DYNJ46301C 23EMD296
- DYNJ61006 lots 21BBM590 21DBE579 25EBA174
- VASC1109 lots 25BBR047
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
Same manufacturer · Medline Industries, LP
See all →- HighMedline IVS Blood Culture Kits Recalled for Sterility Breach
FDA (Devices) · 2026-09-09
- HighMedline Blood Culture Kits Recalled Due to Potential Seal Defects
FDA (Devices) · 2026-09-09
- HighMedline Convenience Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- SevereMedline Eye and Cataract Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- SevereMedline Ultrasound Breast Pack Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
Same hazard · regulatory clearance
See all →- ModerateCovidien Mon-a-Therm general purpose temperature probes lack FDA clearance
FDA (Devices) · 2026-06-10
- ModerateCovidien 9 Fr Mon-a-Therm temperature probes lack FDA clearance
FDA (Devices) · 2026-06-10
- ModerateCovidien esophageal stethoscope temperature sensors lack FDA clearance
FDA (Devices) · 2026-06-10
- ModerateMedline left heart kits recalled after 510(k) clearances were rescinded
FDA (Devices) · 2026-04-29
- ModerateBlood gas cartridges recalled for lacking clearance covering updated measurement ranges
FDA (Devices) · 2025-09-24