Non-sterile Syringes Recalled for Unapproved Specifications
Jiangsu Shenli Medical Production is recalling approximately 749,400 non-sterile syringes (10ml) distributed under the Medline brand because their sizes and configurations were not cleared by FDA.
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 an FDA Class II recall, but no illnesses, injuries, or hospitalizations have been reported. The hazard is regulatory non-compliance (unapproved specifications), making this a precautionary recall without documented harm.
Plain-English summary
Jiangsu Shenli Medical Production Co., Ltd. is recalling approximately 749,400 non-sterile syringes (10ml, Model 91834) distributed under the Medline brand. The recalled products were manufactured in sizes and configurations that are outside the range of devices cleared under the firm's FDA 510(k) submission.
The products do not comply with FDA clearance requirements because their specifications were not approved prior to distribution. This regulatory non-compliance may create risks related to product performance and safety.
The recalled syringes were distributed nationwide with specific distribution to California, Florida, Georgia, Illinois, Tennessee, and Virginia through healthcare facilities and distributors. Consumers and healthcare providers should discontinue use of the affected syringes and contact their supplier for return instructions.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 10ML L/L YELLOW Model/Catalog Number: 91834 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-specification
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
- 63721010001
- 63721070001
- 63721080001
- 63721090001
- 63721100001
- 63721110001
- 63721120001
- 63722030001
- 63722040002
- 63722040004
- 63722050001
- 63722060001
- 63722070002
- 63722080002
- 63722090002
- 63723030001
- 63723050001
- 63723070001
- 63723090002
Distribution
Distributed nationwide across the United States.
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