Medline 10mL Polycarbonate Colored Syringes Convenience Kits Recalled
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA clearance requirements.
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 classification is Class II. The source text contains no reports of hospitalization, injury, or illness. The hazard is an unapproved design change, which does not meet the thresholds for High (reported illness/injury) or above per the rubric.
Plain-English summary
Medline Industries, LP is recalling convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes, identified by the kit number DYNJ85723. The recall affects approximately 113,843 kits that were distributed nationwide across the United States, including Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Wisconsin, Wyoming, and Barbados.
The manufacturer identified unapproved design changes to the products that were made outside of the 510(k) clearance granted by the FDA. These products were not initially reported in a related recall (RES 98601).
Patients and healthcare providers currently using or possessing these kits should discontinue use and contact Medline Industries, LP or the FDA for instructions on how to proceed. Healthcare facilities should review their inventory and isolate affected units to prevent further distribution or use.
The recalled product
- Product
- Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. MAJOR BASIN SET DYNJ85723
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Syringes
- Affected units
- 113,843
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)
- DYNJ85723 UDI-DI 10195327538491 Lot 24ABO130
Distribution
Part of a larger recall action
This product is one of 16 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 16 products in this recall →Related recalls
Same manufacturer · Medline Industries, LP
See all →- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Assembly Disconnect Risk
FDA (Devices) · 2026-10-14
- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Detachment Risk
FDA (Devices) · 2026-10-14
- SevereMedline Homecare Bed Hand Pendants Recalled for Fire Hazard
FDA (Devices) · 2026-10-07
- SevereMedline Homecare Beds Recalled for Fire Hazard in Hand Control Pendant
FDA (Devices) · 2026-10-07
- HighMedline Instrument Channel Brush Kits Recalled for Sharp Edges
FDA (Devices) · 2026-09-30
Same hazard · unapproved design change
See all →- SevereMedical Device Surgical Kits with Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
- SevereMedline Convenience Kits with Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
- SevereMedline polycarbonate syringes recalled for unapproved design changes
FDA (Devices) · 2026-07-01
- ModerateMedline Polycarbonate Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
- HighMedline Industries Polycarbonate Syringes Convenience Kits Design Change Recall
FDA (Devices) · 2026-07-01
Similar recalls
- ModerateMedline Convenience Kits with Polycarbonate Syringes Recalled
FDA (Devices) · 2026-04-29
- ModerateMedline Polycarbonate Colored Syringes Kits Recalled for Unapproved Design Changes
FDA (Devices) · 2026-04-29
- SevereMedline Convenience Kits with 10mL Polycarbonate Colored Syringes Recalled
FDA (Devices) · 2026-04-29
- ModerateMedline Convenience Kits with Polycarbonate Syringes Unapproved Design Changes
FDA (Devices) · 2026-04-29
- ModerateMedline Convenience Kits with 10mL Syringes recalled for unapproved design changes
FDA (Devices) · 2026-04-29
- HighMedline Convenience Kits With Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-04-29