Medline Non-Sterile Syringes Recalled for Non-Compliant Manufacturing Specifications
Medline non-sterile syringes (Model 91858) are recalled for manufacturing outside FDA-cleared specifications. The recall covers 50,400 units distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for medical devices manufactured outside approved specifications with no reported illnesses or injuries. Non-compliant syringes qualify as risk-of-harm products where injury has not yet been reported, justifying a High severity classification.
Plain-English summary
Medline non-sterile syringes (Model 91858, 20mL capacity, single-use without needles) are being recalled by manufacturer Jiangsu Shenli Medical Production Co., Ltd. The syringes were manufactured in sizes and configurations that fall outside those cleared by the FDA under the firm's 510(k) submission.
The recall affects approximately 50,400 units distributed nationwide in California, Florida, Georgia, Illinois, Tennessee, and Virginia. Products were shipped through major U.S. ports including Los Angeles, Long Beach, Chicago, Miami, Savannah, Nashville, and Norfolk.
Affected lot codes are: 63721010001, 63721070001, 63721090001, 63721100001, 63721120001, 63722020002, 63722050001, 63722100003, 63723020001, 63723030001, 63723050001, 63723060001, 63723070001, and 63723120002. Customers should verify their inventory against these lot numbers to identify affected stock.
The non-compliance with FDA-cleared specifications creates a potential risk that the devices may not function as intended or approved.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 20ML L/L WHITE SALINE Model/Catalog Number: 91858 Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Category
- Medical Device — Syringes
- Hazard
- out-of-specification
- device-malfunction
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 (14)
- Lot Code: LOT: 63721010001
- 63721070001
- 63721090001
- 63721100 001
- 63721120001
- 63722020002
- 63722050001
- 63722100003
- 63723020001
- 63723030001
- 63723050 001
- 63723060001
- 63723070001
- 63723120002
Distribution
Distributed nationwide across the United States.
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