Medline 20mL Non-Sterile Syringes Recalled for Design Specification Deviation
Medline non-sterile 20mL syringes (Model 91835) are being recalled because the piston sizes and configurations do not match FDA-cleared specifications. Approximately 39,200 units are affected.
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 of a medical device with specification deviations affecting piston size and configuration. Although no illnesses or injuries have been reported, the specification deviation poses a risk to proper product function and performance, qualifying as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Medline is recalling non-sterile 20mL syringes without needles (Model 91835) manufactured by Jiangsu Shenli Medical Production Co., Ltd. The recalled product is distributed nationwide in California, Florida, Georgia, Illinois, Tennessee, and Virginia. Approximately 39,200 units are affected.
The piston sizes and configurations of the recalled syringes do not match the range of devices cleared by the FDA under the firm's 510(k) submission. This specification deviation may impact the proper performance of the syringes.
The syringes were distributed to customers across the United States via ports in Shanghai, Chicago, Los Angeles, Long Beach, Miami, Savannah, Nashville, and Norfolk. The affected lot codes are: 63721070001, 63721080001, 63721090001, 63721100001, 63722080002, 63722090002, 63722100003, 63723070001, and 63723090002.
Healthcare facilities and consumers who have the recalled syringes should discontinue use immediately and contact Medline for replacement or return instructions.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 20ML L/L RED Model/Catalog Number: 91835 Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Hazard
- specification-deviation
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 (9)
- Lot Code: LOT: 63721070001
- 63721080001
- 63721090001
- 63721100001
- 63722080002
- 63722090002
- 63722100003
- 63723070001
- 63723090002
Distribution
Distributed nationwide across the United States.
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