Medline non-sterile syringes recalled for exceeding cleared device specifications
Jiangsu Shenli is recalling Medline 20mL non-sterile syringes (Model 91836, 133,600 units) because certain lot configurations exceed the scope of FDA-cleared specifications. Affected units were distributed across six U.S. states.
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 a Class II recall without reported hospitalizations, injuries, or illnesses. The issue is regulatory non-compliance—the devices fall outside the scope of FDA-cleared specifications—rather than an active safety hazard with documented harm.
Plain-English summary
What is being recalled: Jiangsu Shenli Medical Production Co., Ltd. is recalling Medline SYR 20ML L/L GREEN non-sterile syringes without needles (Model 91836). The recall involves 133,600 units distributed under the Medline brand.
Why: The piston syringe sizes and configurations included in this recall fall outside the range of devices cleared under the manufacturer's 510(k) submission. This means the devices were not approved for those particular specifications.
Who is affected: The recalled syringes were distributed nationwide in California, Florida, Georgia, Illinois, Tennessee, and Virginia through various U.S. ports and distribution centers including Chicago, Los Angeles, Long Beach, Miami, Savannah, Nashville, and Norfolk.
What consumers should do: Healthcare facilities and users should stop using the affected lots (63721070001, 63721080001, 63721090001, 63721100001, 63721120001, 63722010001, 63722030001, 63722060001, 63722090002, 63723010001, 63723020001, 63723030001, 63723060001, 63723070001, 63723090002) and contact their medical supplier or Jiangsu Shenli for guidance on return or replacement.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 20ML L/L GREEN Model/Catalog Number: 91836 Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Category
- Medical Device — Syringes
- Hazard
- unapproved-device
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 (15)
- Lot Code: LOT: 63721070001
- 63721080001
- 63721090001
- 63721100 001
- 63721120001
- 63722010001
- 63722030001
- 63722060001
- 63722090002
- 63723010001
- 63723020001
- 63723030001
- 63723060001
- 63723070001
- 63723090002
Distribution
Distributed nationwide across the United States.
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