FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation
International Medsurg Connection, Inc. is recalling 16-gauge hypodermic needles because the company lacks sufficient documentation to support the product's 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, which typically indicates a situation where use of the product could cause temporary or medically reversible health consequences. The specific issue is a documentation deficiency regarding sterility claims rather than a confirmed contamination or injury event, fitting the criteria for a moderate severity score.
Plain-English summary
International Medsurg Connection, Inc. is recalling 54,204,100 units of 16-gauge, 1.5-inch hypodermic needles (Catalog No. N3601615). The recall was initiated because the company does not have sufficient documentation to support the product's sterility claims. These needles are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease.
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. The recall covers specific lot numbers ranging from 12-6780-x to 17-1791-x, where 'x' represents any release number.
Healthcare facilities and distributors should check their inventory for the specific catalog and lot numbers listed in the recall notice. If the affected products are found, they should be removed from use and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- Product
- Hypodermic Needle, 16G X 1.5in DSP REG BEVEL, 100 per box, 50 boxes/case, 5,000/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, mitigation, treatment…
- 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
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- 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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