Medline 10mL Syringes Recalled for Manufacturing Outside Approved Specifications
Medline is recalling approximately 525,700 non-sterile 10mL syringes manufactured with sizes and configurations exceeding FDA-approved specifications. No injuries or illnesses have been reported.
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: Class II medical device recall where manufactured devices exceed FDA-approved specifications. Although no injuries or illnesses have been reported, out-of-specification medical syringes represent a documented risk-of-harm product requiring preventative recall.
Plain-English summary
Medline is recalling non-sterile, single-use 10mL syringes without needles (Model 91830) manufactured by Jiangsu Shenli Medical Production Co., Ltd. Approximately 525,700 syringes are affected, identified by 24 specific lot codes ranging from 63721010001 through 63723120002.
The recall was initiated because the manufactured syringes have sizes and configurations that exceed the range of specifications cleared by the FDA in the company's 510(k) regulatory submission. Devices manufactured outside this approved specification range have not undergone the same regulatory evaluation required for safety and effectiveness.
The recalled syringes were distributed nationwide in California, Florida, Georgia, Illinois, Tennessee, and Virginia through multiple U.S. distribution points including Chicago, Los Angeles, Long Beach, Miami, Savannah, Nashville, and Norfolk.
Healthcare facilities and consumers who have received syringes matching the recalled lot codes should stop using them immediately and contact the manufacturer or Medline for return or replacement instructions. As of the date of this notice, no injuries or illnesses have been reported in connection with these recalled devices.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 10ML L/L RED Model/Catalog Number: 91830 Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Category
- Medical Device — Syringes
- Hazard
- device-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 (20)
- Lot Code: LOT: 63721010001
- 63721060001
- 63721070001
- 63721080001
- 63721090001
- 63721100001
- 63721110001
- 63721120001
- 63722010001
- 63722020002
- 63722030001
- 63722040002
- 63722050001
- 63722060001
- 63722070002
- 63722080002
- 63722100003
- 63723020001
- 63723030001
- 63723050001
Distribution
Distributed nationwide across the United States.
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