FDA Recalls Piston Syringes Due to Insufficient Sterility Documentation
International Medsurg Connection is recalling 54.2 million piston syringes and hypodermic needles because the company lacks documentation to support the products' sterility claims.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: The recall is classified as FDA Class II, but the specific issue is a documentation deficiency regarding sterility claims rather than a confirmed contamination or reported injury, aligning with the rubric for moderate severity involving low-risk or theoretical hazards.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Piston Syringe and Hypodermic Needle, 5 CC L/L 21 G X 1.5, manufactured by International Medsurg Connection, Inc. The recall involves 54,204,100 units of the product, which is used to inject fluids into or withdraw fluids from the body for the diagnosis, cure, mitigation, treatment, or prevention of disease.
The recall was initiated due to insufficient documentation to support the product's sterility claims. The affected products were distributed nationwide, including in Ohio, Massachusetts, Georgia, Florida, North Carolina, Mississippi, Missouri, Pennsylvania, Indiana, New Jersey, Texas, Kansas, Louisiana, Nebraska, Washington, Alabama, Utah, Alaska, California, Illinois, Minnesota, Maryland, New York, and Michigan.
Healthcare providers and consumers should stop using the affected syringes and needles and contact International Medsurg Connection, Inc. for further instructions. The specific lot numbers involved in the recall are extensive and include various release numbers from 2012 through 2017, such as 12-6780-x, 13-7538-x, and 17-1791-x.
The recalled product
- Product
- Piston Syringe and Hypodermic Needle, 5 CC L/L 21 G X 1.5, 100 per box, 15 boxes/case, 1,500/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure…
- Manufacturer
- International Medsurg Connection, Inc.
- Hazard
- Affected units
- 54,204,100
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)
- 12-6925-x
- 12-6968-x
- 12-7060-x
- 12-7119-x
- 12-7144-x
- 12-7177-x
- 12-7208-x
- 12-7258-x
- 12-7259-x
- 12-7324-x
- 12-7325-x
- 12-7363-x
- 12-7391-x
- 12-7412-x
- 12-7463-x
- 12-7469-x
- 12-7472-x
- 12-7499-x
- 13-6780-x
- 13-7538-x
Distribution
Part of a larger recall action
This product is one of 59 recalled by International Medsurg Connection, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 59 products in this recall →Related recalls
Same manufacturer · International Medsurg Connection, Inc.
See all →- ModerateFDA Recalls Piston Syringes Due to Insufficient Sterility Documentation
FDA (Devices) · 2017-08-16
- ModerateFDA Recalls Piston Syringes and Hypodermic Needles Due to Sterility Documentation Issues
FDA (Devices) · 2017-08-16
- HighFDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation
FDA (Devices) · 2017-08-16
- ModerateFDA Recalls Piston Syringes Due to Insufficient Sterility Documentation
FDA (Devices) · 2017-08-16
- ModerateFDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation
FDA (Devices) · 2017-08-16
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FDA (Devices) · 2019-12-04
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