FDA Recalls Medline Non-Sterile Syringes for Regulatory Non-Compliance
Medline has recalled approximately 325,500 non-sterile syringes (Model 91831) due to syringe sizes and configurations that fall outside FDA-cleared specifications. The syringes were distributed nationwide and manufactured by Jiangsu Shenli Medical Production Co., Ltd.
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: FDA Class II recall based on regulatory non-compliance (device specifications outside cleared range). The stated hazard is a manufacturing and design issue with no reported illnesses, injuries, or direct patient harm mechanisms described in the source.
Plain-English summary
Medline has issued a recall of approximately 325,500 non-sterile syringes (Model SYR 10ML L/L GREEN, Catalog Number 91831) manufactured by Jiangsu Shenli Medical Production Co., Ltd. These syringes are designed for single use without needles.
The recall was initiated because the syringe sizes and configurations fall outside the range of specifications cleared by the FDA under the manufacturer's 510(k) authorization.
The affected syringes were distributed nationwide in California, Florida, Georgia, Illinois, Tennessee, and Virginia, with shipments routed through major U.S. ports including Chicago, Los Angeles, Long Beach, Miami, Savannah, Nashville, and Norfolk. Multiple lot codes are affected; specific lot information is available in the FDA recall notice (Z-2063-2024).
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 10ML L/L GREEN Model/Catalog Number: 91831 Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Category
- Medical Device — Syringes
- Hazard
- regulatory-non-compliance
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
- 63722020002
- 63722030001
- 63722040002
- 63722050001
- 63722060001
- 63722070002
- 63722080002
- 63722090002
- 63722120002
- 63723020001
- 63723030001
- 63723050001
Distribution
Distributed nationwide across the United States.
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