The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2848-2017·Announced 2017-08-16

FDA Recalls Piston Syringes and Hypodermic Needles Due to Sterility Documentation Issues

International Medsurg Connection, Inc. is recalling 54,204,100 piston syringes and hypodermic needles nationwide because the company lacks sufficient documentation to support the products' 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 source text identifies the issue as insufficient documentation to support sterility claims, which aligns with the rubric for moderate severity involving documentation issues or low-risk contamination without reported illness.

Plain-English summary

International Medsurg Connection, Inc. is recalling 54,204,100 units of Piston Syringe and Hypodermic Needle, 10 CC L/L 22 G X 1.0. The products are used to inject fluids into, or withdraw fluids from, the body for the diagnosis, cure, mitigation, treatment, or prevention of disease. The recall is being conducted because the firm has insufficient documentation to support the 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 includes specific catalog and lot numbers, with lot numbers ranging from 12-6780-x to 17-1791-x.

Healthcare providers and consumers should stop using these products and contact International Medsurg Connection, Inc. for further instructions on how to return or dispose of the recalled items.

The recalled product

Product
Piston Syringe and Hypodermic Needle, 10 CC L/L 22 G X 1.0, 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…
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 →

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