Medline non-sterile syringes recalled for manufacturing outside FDA clearance scope
Medline non-sterile syringes (Model 83084) are being recalled because they were manufactured in sizes and configurations outside the scope of FDA clearance.
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 an FDA Class II recall with no reported illnesses or injuries. The hazard is regulatory non-compliance—manufacturing outside the cleared scope—which is a compliance and precautionary issue rather than an identified safety defect.
Plain-English summary
Medline, through Jiangsu Shenli Medical Production Co., Ltd., is recalling model 83084 non-sterile syringes without needles for single use. Approximately 11,584,000 units are affected.
The syringes are subject to recall because they were manufactured in piston syringe sizes and configurations that are outside the range of devices cleared by the FDA under the firm's 510(k) submission. The devices were produced beyond the scope of what was approved for manufacture and distribution.
The affected products were distributed across California, Florida, Georgia, Illinois, Tennessee, and Virginia. Consumers should contact Medline or their healthcare provider regarding the proper handling and replacement of these recalled syringes.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 3ML L/L Model/Catalog Number: 83084 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
- 11,584,000
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 (20)
- Lot Code: LOT: 63720120007
- 63721010002
- 63721010003
- 63721010004
- 63721020002
- 63721040002
- 63721050002
- 63721060002
- 63721070001
- 63721080001
- 63721090001
- 63721100001
- 63721110001
- 63721120001
- 63721120003
- 63721120004
- 63722010001
- 63722030001
- 63722040004
- 63722050001
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.
See all 87 products in this recall →Related recalls
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