Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2827-2017·Announced 2017-08-16

FDA Recalls Piston Syringes Due to Insufficient Sterility Documentation

International Medsurg Connection, Inc. is recalling 54,204,100 piston syringes and hypodermic needles because the company lacks sufficient documentation to support product 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, and the hazard is a documentation issue regarding sterility claims rather than a confirmed contamination or injury, fitting the 'Moderate' criteria for minor labeling/documentation errors or low-risk issues.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Piston Syringe and Hypodermic Needle, 1 CC TB 28 G X 0.5, manufactured by International Medsurg Connection, Inc. The recall affects 54,204,100 units of the product, which is sold in boxes of 100 and cases of 30 boxes (3,000 units per case). The specific reason for the recall is insufficient documentation to support product 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. The recall covers a wide range of lot numbers, specifically Catalog No. SN0012805, with lot numbers ranging from 12-6780-x to 17-1791-x, where 'x' represents any release number.

Consumers and healthcare facilities should check their inventory for the affected lot numbers and stop using the product if it matches the recalled items. The FDA classifies this as a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The recalled product

Product: Piston Syringe and Hypodermic Needle, 1 CC TB 28 G X 0.5, 100 per box, 30 boxes/case, 3,000/case
Manufacturer: International Medsurg Connection, Inc.
Category: Medical Device — Syringes and Needles
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