The Recall Desk
ModerateFDA (Devices)·Z-2845-2017·Announced 2017-08-16

FDA Recalls Piston Syringes Due to Insufficient Sterility Documentation

International Medsurg Connection is recalling 54,204,100 piston syringes and hypodermic needles because the company lacks sufficient documentation to support the products' sterility claims.

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, which typically corresponds to a Moderate severity score (2) in the absence of reported hospitalizations or serious injuries, as the hazard is a documentation deficiency rather than a confirmed contamination event.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Piston Syringe and Hypodermic Needle, 10 CC L/L 20 G X 1.5, manufactured by International Medsurg Connection, Inc. The recall involves 54,204,100 units of the product, which are used to inject fluids into, or withdraw fluids from, the body for the diagnosis, cure, mitigation, treatment, or prevention of disease.

The reason for the recall is insufficient documentation to support the product's sterility claims. The FDA classifies this as a Class II recall, which indicates 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 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 specific lot numbers affected are listed in the structured product information. Consumers and healthcare providers should check their inventory for these specific catalog and lot numbers and stop using the products if they match the recall description.

The recalled product

Product
Piston Syringe and Hypodermic Needle, 10 CC L/L 20 G X 1.5, 100 per box, 10 boxes/case, 1,000/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, mitigatio
Manufacturer
International Medsurg Connection, Inc.
Category
Medical Device — Syringes and Needles
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

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 →

Related recalls

Same manufacturer · International Medsurg Connection, Inc.

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Same hazard · sterility documentation

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