MEDLINE Non-Sterile Syringes Recalled for Unapproved Sizes and Configuration
Medline non-sterile syringes are recalled because their piston sizes and configurations exceed those approved by the FDA. No injuries have been reported. Approximately 230,800 units were distributed nationwide across six states.
What this means for you
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 regulatory compliance recall—the device configurations were not included in the FDA's 510(k) clearance. No illnesses or injuries have been reported, and the source does not identify a specific physical hazard, making this a compliance-based precautionary recall rather than one driven by demonstrated harm.
Plain-English summary
Jiangsu Shenli Medical Production Co., Ltd. is recalling approximately 230,800 MEDLINE non-sterile syringes (Model 91837) for single use without needles. The syringes are being recalled because their piston sizes and configurations exceed those approved by the FDA under the manufacturer's 510(k) clearance.
The affected units are distributed nationwide, primarily in California, Florida, Georgia, Illinois, Tennessee, and Virginia. The recall impacts 18 specific lot codes produced by the manufacturer. No illnesses or injuries have been reported in connection with this recall.
Consumers and healthcare facilities should stop using syringes from the affected lot codes and contact the manufacturer or their medical supplier for instructions on return or replacement. Specific lot numbers and additional information are available through the FDA website and the manufacturer.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 20ML L/L BLUE Model/Catalog Number: 91837 Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Affected units
- 230,800
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 (19)
- Lot Code: LOT: 63721010004
- 63721040002
- 63721050002
- 63721060001
- 63721070001
- 63721080001
- 63721100001
- 63722050001
- 63722090002
- 63722100003
- 63722120002
- 63723020001
- 63723030001
- 63723050001
- 63723060001
- 63723070001
- 63723090002
- 63723100003
- 63723120002
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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