Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2831-2017·Announced 2017-08-16

FDA Recalls Piston Syringes Due to Insufficient Sterility Documentation

International Medsurg Connection is recalling 54.2 million piston syringes and hypodermic needles because documentation supporting sterility claims is insufficient.

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 source text identifies the issue as insufficient documentation rather than a confirmed contamination or injury event, fitting the criteria for a moderate risk or precautionary recall.

Plain-English summary

The U.S. Food and Drug Administration has issued a Class II recall for Piston Syringe and Hypodermic Needle, 3 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 diagnosis or treatment purposes.

The recall was initiated because there is 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. The specific lot numbers are listed in the official recall notice, with catalog number SN0032115. Users should contact the manufacturer or their supplier for further instructions on how to handle the recalled items.

The recalled product

Product: Piston Syringe and Hypodermic Needle, 3 CC L/L 21 G X 1.5, 100 per box, 24 boxes/case, 2,400/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.
Category: Medical Device — Syringes and Needles
Hazard: documentation-deficiency
sterility-uncertainty
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