MEDLINE Piston Syringes Recalled for Out-of-Range Specifications
Jiangsu Shenli Medical Production recalled 1.7 million MEDLINE piston syringes because the devices' sizes and configurations exceed what was cleared by the FDA. The affected syringes were distributed nationwide across multiple states.
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: FDA Class II recall due to regulatory non-compliance: devices exceed the specifications cleared under the firm's 510(k). The source identifies no specific safety hazard and reports no illnesses or injuries, making this a precautionary regulatory recall.
Plain-English summary
MEDLINE SYR 1ML TB piston syringes (Model 83089) manufactured by Jiangsu Shenli Medical Production Co., Ltd. are being recalled because the devices' sizes and configurations are outside the range cleared by the FDA under the firm's 510(k) submission. Approximately 1.7 million units are affected.
The recalled syringes were distributed nationwide in California, Florida, Georgia, Illinois, Tennessee, and Virginia through ports and warehouses in Chicago, Los Angeles, Long Beach, Miami, Savannah, Nashville, and Norfolk. Multiple lot codes are affected, including lots 63720120007, 63721010002, 63721060002, and others identified by the manufacturer.
Consumers and healthcare facilities with these syringes should stop using them and contact their distributor for instructions on return or replacement.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 1ML TB Model/Catalog Number: 83089 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
- 1,700,000
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
- 63721060002
- 63721070001
- 63721080001
- 63721090004
- 63721100001
- 63721110001
- 63721120001
- 63722010001
- 63722030001
- 63722040002
- 63722050001
- 63722060001
- 63722080002
- 63722090002
- 63722120002
- 63723010001
- 63723050001
- 63723060001
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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