Medline Non-Sterile Syringes Recalled for Offering Configurations Outside FDA Approved Clearance Scope
Medline non-sterile syringes are being recalled because configurations and sizes sold exceeded the FDA's approved 510(k) scope. Approximately 502,250 units were distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall due to device configurations and sizes sold beyond the approved 510(k) scope. No reported illnesses or injuries, but syringes represent risk-of-harm products with unapproved designs that lacked proper regulatory clearance.
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.
Lot numbers (20)
- Lot Code: LOT: 63721010001
- 63721060001
- 63721070004
- 63721080001
- 63721090001
- 63721110001
- 63721120001
- 63722010001
- 63722030001
- 63722040004
- 63722050001
- 63722060001
- 63722070005
- 63722100003
- 63722120002
- 63723010002
- 63723020001
- 63723030001
- 63723050001
- 63723060001
Distribution
Distributed nationwide across the United States.
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