Medline 20mL Non-Sterile Syringes Recalled for Configuration Non-Conformance
Medline syringes (Model 91845) distributed across six US states are recalled because their piston configurations don't match FDA-cleared design specifications. The recall affects approximately 40,800 units.
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 medical device recall with no reported illnesses or injuries. The non-conformance involves configuration specifications exceeding cleared design parameters, without a stated mechanism of patient harm. Per rubric criteria for recalls lacking reported illness and theoretical risk, scored as Moderate.
Plain-English summary
Medline SYR 20ML L/L BLUE SALINE syringes (Model 91845) are being recalled by the FDA due to regulatory non-compliance. These are non-sterile single-use syringes without needles, manufactured by Jiangsu Shenli Medical Production Co., Ltd. Approximately 40,800 units distributed in California, Florida, Georgia, Illinois, Tennessee, and Virginia are affected.
The syringes in question have piston sizes and configurations that exceed the range of devices cleared by the FDA under the manufacturer's 510(k) submission. This represents a deviation from the approved design specifications.
The affected products were distributed following customer orders, with shipments directed to major US destinations including Chicago, Los Angeles, Long Beach, Miami, Savannah, Nashville, and Norfolk.
Additional information regarding this recall should be obtained from the FDA or the manufacturer. The FDA reference number for this recall is Z-2075-2024.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 20ML L/L BLUE SALINE Model/Catalog Number: 91845 Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Category
- Medical Device — Syringes
- Hazard
- configuration-mismatch
- regulatory-non-conformance
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 (10)
- Lot Code: LOT: 63721060001
- 63721070001
- 63722020002
- 63722030 001
- 63722040004
- 63722090002
- 63722100003
- 63723020001
- 63723060001
- 63723090002
Distribution
Distributed nationwide across the United States.
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