Moderate FDA (Devices)·Z-2814-2017·Announced 2017-08-16

FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation

International Medsurg Connection is recalling hypodermic needles because documentation supporting sterility claims is insufficient. The recall covers 54,204,100 units distributed nationwide.

What this means for you

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 and involves a documentation issue regarding sterility claims rather than a confirmed contamination or reported injury, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for hypodermic needles manufactured by International Medsurg Connection, Inc. The specific product is the Hypodermic Needle, 22 G X 1.0 in REG BEVEL, sold in boxes of 100. The recall was initiated because the firm could not provide sufficient documentation to support its claims that the products were sterile.

The recall affects a total of 54,204,100 units. These products were distributed nationwide, including to facilities 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 needles are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease.

Healthcare facilities and distributors should stop using the affected products and contact International Medsurg Connection, Inc. for further instructions. The FDA classifies this as a Class II recall, which means the product may cause temporary or medically reversible health consequences, or where the probability of serious adverse health consequences is remote.

The recalled product

Product: Hypodermic Needle, 22 G X 1.0 in 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 or
Manufacturer: International Medsurg Connection, Inc.
Category: Medical Device — Surgical Instruments
Hazard: documentation-deficiency
sterility-claim
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

Distributed nationwide across the United States.

The notice also names 24 states specifically:

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 →

Same manufacturer · International Medsurg Connection, Inc.

See all →

Moderate
FDA Recalls Piston Syringes Due to Insufficient Sterility Documentation
FDA (Devices) · 2017-08-16
Moderate
FDA Recalls Piston Syringes and Hypodermic Needles Due to Sterility Documentation Issues
FDA (Devices) · 2017-08-16
High
FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation
FDA (Devices) · 2017-08-16
Moderate
FDA Recalls Piston Syringes Due to Insufficient Sterility Documentation
FDA (Devices) · 2017-08-16
Moderate
FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation
FDA (Devices) · 2017-08-16

Same hazard · documentation deficiency