Non-Sterile Syringes Recalled for Regulatory Non-Compliance and Design Deviation
Jiangsu Shenli Medical is recalling 7,000 MEDLINE non-sterile syringes because their sizes and configurations exceed FDA 510(k) approval. The syringes were distributed nationwide and may pose infection risks.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves non-sterile medical devices distributed outside approved specifications. While no illnesses or injuries are reported in the source, the product presents a theoretical infection risk. The score applies the rubric criterion for high-risk products where injury has not yet been reported.
Plain-English summary
Jiangsu Shenli Medical Production Co., Ltd., is recalling approximately 7,000 MEDLINE SYR 10ML/L BLUE CONTRAST non-sterile syringes without needles (Model 91848, Lot Code 63721010001). The syringes are intended for single use.
The recall was issued because the syringes' sizes and configurations exceed those cleared under the firm's 510(k) submission to the FDA. This deviation means the devices do not conform to their approved design specifications.
The affected syringes were distributed nationwide to customers in California, Florida, Georgia, Illinois, Tennessee, and Virginia through U.S. ports including Chicago, Los Angeles, Long Beach, Miami, Savannah, Nashville, and Norfolk.
Facilities or individuals in possession of these syringes should contact Jiangsu Shenli Medical Production Co., Ltd., for instructions on return or replacement.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 10ML/L BLUE CONTRAST Model/Catalog Number: 91848 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
- 7,000
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 (1)
- Lot Code: LOT: 63721010001
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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