Non-Sterile Syringes Recalled Outside FDA-Cleared Size and Configuration Range
Medline is recalling 820,400 non-sterile syringes (model 91832) because their sizes and configurations fall outside what was cleared by the FDA. The devices were not manufactured within the approved specifications.
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 without reported illnesses or injuries. The syringes do not match their FDA-approved specifications, but the source does not describe a specific hazard or adverse events.
Plain-English summary
Jiangsu Shenli Medical Production Co., Ltd. is recalling 820,400 non-sterile syringes sold under the Medline brand (model 91832, lot codes 63721010001 through 63723120002). These are 10-mL syringes without needles intended for single use.
The syringes are being recalled because their sizes and configurations fall outside the range of devices that were cleared by the FDA under the manufacturer's 510(k) approval. This means the devices were not manufactured according to the FDA-approved specifications.
The affected syringes were distributed nationwide in California, Florida, Georgia, Illinois, Tennessee, and Virginia through customer orders and deliveries to ports including Shanghai, Chicago, Los Angeles, Long Beach, Miami, Savannah, Nashville, and Norfolk.
Consumers and healthcare facilities that have received these syringes should stop using them and contact Jiangsu Shenli Medical Production or their supplier for replacement or return instructions.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 10ML L/L BLUE Model/Catalog Number: 91832 Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Category
- Medical Device — Syringes
- Hazard
- specification-mismatch
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: 63721010001
- 63721060001
- 63721070001
- 63721080001
- 63721090001
- 63721100001
- 63721110001
- 63721120001
- 63722010001
- 63722020002
- 63722030001
- 63722040002
- 63722050001
- 63722060001
- 63722070002
- 63722080002
- 63722100003
- 63723020001
- 63723030001
- 63723050001
Distribution
Distributed nationwide across the United States.
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