Non-sterile syringes recalled for configurations exceeding FDA clearance
Medline is recalling approximately 95,200 non-sterile 5mL syringes (Model 91825) distributed nationwide because syringe sizes and configurations exceed the scope of FDA 510(k) clearance.
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 with no reported illnesses or injuries. The issue is a regulatory compliance matter—the syringe configurations exceed the scope of the FDA 510(k) clearance. Without reported harm or a specific documented safety hazard, this is classified as a precautionary compliance recall.
Plain-English summary
Medline, via manufacturer Jiangsu Shenli Medical Production Co., Ltd., is recalling approximately 95,200 non-sterile 5mL syringes without needles (Model 91825, product name SYR 5ML L/L RED). The syringe sizes and configurations covered by this recall exceed the range of devices cleared under the firm's 510(k) premarket notification.
Affected products were distributed nationwide in the states of California, Florida, Georgia, Illinois, Tennessee, and Virginia. The recalled lot codes are: 63721010001, 63721060001, 63721070001, 63721080001, 63721090001, 63721120001, 63722010001, 63722050001, 63722080002, 63722100003, 63723060001, 63723070001, and 63723120002.
The FDA has not identified any reported illnesses or injuries associated with use of these products. Healthcare facilities and end-users in possession of affected syringes should cease use and contact Medline or the manufacturer for return instructions.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 5ML L/L RED Model/Catalog Number: 91825 Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- 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 (13)
- Lot Code: LOT: 63721010001
- 63721060001
- 63721070001
- 63721080001
- 63721090001
- 63721120001
- 63722010001
- 63722050001
- 63722080002
- 63722100003
- 63723060001
- 63723070001
- 63723120002
Distribution
Distributed nationwide across the United States.
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