Medline Non-Sterile Syringes Recalled for Exceeding FDA-Cleared Specifications
Jiangsu Shenli Medical is recalling about 38.8 million Medline SYR 10ML L/L non-sterile syringes (Model 83082) because their sizes and configurations exceed FDA-cleared specifications. Nationwide distribution in CA, FL, GA, IL, TN, and VA.
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 with no reported illnesses or injuries. The hazard is regulatory non-compliance—devices exceed specifications cleared in the firm's 510(k)—representing a precautionary concern without an identified acute safety threat or reported adverse events.
Plain-English summary
Jiangsu Shenli Medical Production Co., Ltd. is recalling Medline SYR 10ML L/L non-sterile syringes without needles (Model 83082). The recall affects approximately 38.8 million units distributed nationwide.
The syringes are being recalled because their sizes and configurations exceed the range of devices cleared under the firm's 510(k) clearance. Affected lot codes include 63721010001, 63721010003, 63721010004, and 71 additional lot numbers through 63723120006.
Distribution was nationwide to California, Florida, Georgia, Illinois, Tennessee, and Virginia through U.S. ports including Chicago, Los Angeles, Long Beach, Miami, Savannah, Nashville, and Norfolk.
Consumers and healthcare providers should stop use of affected lots and contact Jiangsu Shenli Medical Production Co., Ltd. for return or disposal instructions.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 10ML L/L Model/Catalog Number: 83082 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
- 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: 63721010001
- 63721010003
- 63721010004
- 63721040002
- 63721050002
- 63721060001
- 63721060002
- 63721070001
- 63721070002
- 63721070003
- 63721070004
- 63721070006
- 63721080001
- 63721080002
- 63721080003
- 63721080004
- 63721080005
- 63721090002
- 63721090003
- 63721090004
Distribution
Distributed nationwide across the United States.
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