Brand Name: MEDLINE Product Name: SYR 5ML L/L GREEN Model/Catalog Number: 91826 Product Description: NON-Sterile syringes without needles for single use Component: No

Recall Insight

This FDA Devices action (record #Z-2058-2024) was formally reported on May 29, 2024, with the manufacturer initiating the action on April 5, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Jiangsu Shenli Medical Production Co., Ltd. is listed as the recalling firm, operating out of Changzhou. Federal records indicate 25200 units are affected.

The documented reason for this recall is: Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). Distribution data in the federal record shows the product reached: U.S. Nationwide distribution in the states of CA, FL, GA, IL, TN, and VA. After customers place US orders, then arrange production, then deliver to the cargos to customer designated port or warehouse, mostly in Shangh…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 2 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.