Medline Polycarbonate Syringes in Convenience Kits Recalled for Unapproved Design Changes
Medline Industries recalled multiple convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA clearance. The company identified these modifications and notified the FDA of the deviation from the approved 510(k) design.
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 a Class II FDA medical device recall involving unapproved design changes outside of 510(k) clearance for syringes used in clinical settings (cardiac catheterization, interventional procedures). Class II recalls with potential for significant harm to health require a Severe classification.
Plain-English summary
Medline Industries, LP is recalling convenience kits containing select 10mL polycarbonate colored syringes. The kits are sold under various names including Angio Drape Pack, Angio Pack, Angiography Pack, Cardiac Cath Pack, Cath Lab Pack, Interventional Radiology Pack, and other hospital-related kits. The affected kits contain multiple SKUs identified by product codes such as DYNJ47665D, DYNJ30565D, DYNJ0854485V, and many others listed with corresponding lot numbers and UDI codes.
The recall was initiated after Medline identified unapproved design changes to the products that were made outside of the FDA's 510(k) clearance. These modifications deviate from the design that the FDA originally cleared. The affected products were not initially reported in RES 98601.
The recalled kits have been distributed nationwide throughout the United States, including in Alabama, Arizona, Arkansas, 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 also to Barbados. A total of 113,843 kits are affected.
Customers who have purchased these kits should stop using them and contact Medline for further instructions regarding return or replacement options.
The recalled product
- Product
- Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO DRAPE PACK (ADLUG)642-LF DYNJ47665D ANGIO PACK DYNJ30565D ANGIOGRAPHY PACK-LF DYNJ0854485V ARTERIOGRAM DYNJ28082D DYNJ28082F CARDIAC CATH DYNJ67349…
- Manufacturer
- Medline Industries, LP
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 · design deviation
See all →- SevereMedical Device Convenience Kits with 10mL Polycarbonate Syringes Recalled
FDA (Devices) · 2026-07-01
- HighSyringes with Needles Recalled for Substantial Design Differences from FDA Approval
FDA (Devices) · 2024-09-18
- HighMultiple Syringe Models Recalled for Deviation from FDA Clearance Specifications
FDA (Devices) · 2024-09-18
- HighFDA Recalls Wolf Medical Disposable Syringes for Non-Conforming Configurations
FDA (Devices) · 2024-05-29
Similar recalls
- HighMedline Convenience Kits With Syringes 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 10mL Syringes Recalled for Unapproved Design
FDA (Devices) · 2026-04-29
- SevereMedline 10mL Polycarbonate Syringes in Convenience Kits recalled
FDA (Devices) · 2026-04-29
- ModerateMedline Convenience Kits with Polycarbonate Syringes Unapproved Design Changes
FDA (Devices) · 2026-04-29
- ModerateMedline convenience kits recalled over unapproved syringe design changes
FDA (Devices) · 2026-04-29