Moderate FDA (Devices)·Z-2858-2017·Announced 2017-08-16

FDA Recalls Piston Syringes Due to Insufficient Sterility Documentation

International Medsurg Connection, Inc. is recalling 54,204,100 piston syringes because the company lacks sufficient documentation to support product 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, and the source text identifies the issue as insufficient documentation rather than a confirmed contamination or injury event, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

International Medsurg Connection, Inc. is voluntarily recalling Piston Syringes, 20 CC L/S (Catalog No. SY35020LS). 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 recall was initiated because the company has insufficient documentation to support product sterility claims. The affected syringes 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.

Healthcare facilities and consumers should check their inventory for the specific catalog number and lot numbers listed in the official FDA recall notice. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations.

The recalled product

Product: Piston Syringe, 20 CC L/S, 100 per box, 9 boxes/case, 900/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 prevention of diseas
Manufacturer: International Medsurg Connection, Inc.
Category: Medical Device — Syringes
Hazard: sterility-documentation
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 · sterility documentation