Medline Heparin Syringes Recalled for Exceeding FDA Approved Scope
Medline non-sterile syringes (Model 91851) are being recalled because their piston sizes and configurations exceed what the FDA approved. Approximately 7,000 units distributed in six states are affected.
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: This is a Class II FDA recall with no reported illnesses or injuries. The issue is regulatory non-compliance—the devices fall outside the FDA's 510(k) clearance scope—rather than a documented manufacturing defect or reported harm.
Plain-English summary
Medline SYR 10ML L/L RED HEPARIN syringes (Model 91851) manufactured by Jiangsu Shenli Medical Production Co., Ltd., are being recalled. These non-sterile syringes without needles were designed for single use. Approximately 7,000 units with lot code 63722100003 are affected.
The syringes are being recalled because their piston sizes and configurations fall outside the range of devices approved by the FDA through the manufacturer's 510(k) clearance. This means the specific models distributed were not included in the FDA's testing and approval review.
The affected syringes were distributed nationwide to healthcare customers in California, Florida, Georgia, Illinois, Tennessee, and Virginia. Healthcare facilities and consumers who have received these syringes should discontinue use and contact the manufacturer or their healthcare provider for guidance on replacement options and proper handling.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 10ML L/L RED HEPARIN Model/Catalog Number: 91851 Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Category
- Medical Device — Syringes
- Affected units
- 7,000
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)
- Lot Code: LOT: 63722100003
Distribution
Part of a larger recall action
This product is one of 87 recalled by Jiangsu Shenli Medical Production Co., Ltd. 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.
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