Medline Non-Sterile Syringes Recalled for Offering Configurations Outside FDA Approved Clearance Scope

Plain-English summary

Medline non-sterile syringes (Model 83077, 30ML/LS size) are being recalled by manufacturer Jiangsu Shenli Medical Production Co., Ltd., due to FDA Class II regulatory violation. The syringes were sold in piston configurations and sizes that exceeded the scope of the manufacturer's FDA 510(k) clearance.

Approximately 502,250 units were affected. The devices were distributed nationwide through retail and medical supply channels to California, Florida, Georgia, Illinois, Tennessee, and Virginia, with shipments coordinated through major U.S. ports including Chicago, Los Angeles, Long Beach, Miami, Savannah, Nashville, and Norfolk.

Consumers and healthcare providers should immediately cease use of affected units and contact the distributor for return instructions. Lot codes associated with this recall are: 63721010001, 63721060001, 63721070004, 63721080001, 63721090001, 63721110001, 63721120001, 63722010001, 63722030001, 63722040004, 63722050001, 63722060001, 63722070005, 63722100003, 63722120002, 63723010002, 63723020001, 63723030001, 63723050001, 63723060001, 63723070001, 63723090002, and 63723100004.

The recalled product

Product

Brand Name: MEDLINE Product Name: SYR 30ML/LS Model/Catalog Number: 83077 Product Description: NON-Sterile syringes without needles for single use Component: No

Manufacturer

Jiangsu Shenli Medical Production Co., Ltd.

Category

Medical Device — Syringes

Hazard

• unapproved-device-configuration
• regulatory-non-compliance

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

Related recalls