Non-sterile Medline syringes recalled for exceeding FDA clearance specifications
Medline 30mL non-sterile syringes (Model 83078) are recalled because their designs fall outside the FDA-cleared specifications. About 4.1 million units distributed in the U.S. 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: FDA Class II medical device non-compliance recall. Syringes manufactured outside FDA-cleared specifications present potential malfunction risk. The hazard is regulatory non-compliance in an injection device with unspecified but potential harm impact.
Plain-English summary
Medline is recalling its 30mL non-sterile syringes without needles (Model 83078) manufactured by Jiangsu Shenli Medical Production Co., Ltd. The recall involves approximately 4.1 million units distributed nationwide in California, Florida, Georgia, Illinois, Tennessee, and Virginia.
The syringes are being recalled because their sizes and configurations fall outside the range of designs approved by the FDA for this manufacturer under the 510(k) clearance process. This non-compliance means the devices do not meet the regulatory specifications under which they were authorized for use.
Multiple lot codes are affected, as identified in the FDA recall notice. The affected syringes were distributed to customers through various U.S. ports including Chicago, Los Angeles, Long Beach, Miami, Savannah, Nashville, and Norfolk.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 30ML L/L Model/Catalog Number: 83078 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 (20)
- Lot Code: LOT: 63720120007
- 63721010002
- 63721050002
- 63721060002
- 63721070001
- 63721070004
- 63721070006
- 63721080001
- 63721080002
- 63721080003
- 63721080004
- 63721080005
- 63721090001
- 63721090004
- 63721090005
- 63721100001
- 63721100002
- 63721110002
- 63721110003
- 63721120001
Distribution
Distributed nationwide across the United States.
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