The Recall Desk
HighFDA (Devices)·Z-0318-2022·Announced 2021-12-08

Blood collection devices recalled due to premature needle retraction

Magnolia Medical Technologies is recalling Steripath Gen2 Blood Collection Systems due to an uptick in complaints of premature needle retraction during blood collection.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II device with documented complaints of premature needle retraction—a mechanical failure affecting a safety-critical function. The hazard creates risk of user injury, but no illnesses or injuries have been reported in the source.

Plain-English summary

Magnolia Medical Technologies, Inc. is recalling the Steripath Gen2 Blood Collection System, a blood collection device used in healthcare settings. The recall affects approximately 137,200 units across four model variants with different needle gauges (21G and 23G) and neck styles (wide and long).

The recall is due to an uptick of complaints associated with premature needle retraction during blood collection. This mechanical failure could prevent the device from functioning as intended and potentially expose users to injury.

The affected devices were distributed nationwide across 27 states and the District of Columbia, including Maryland, West Virginia, Delaware, Virginia, Indiana, Michigan, Massachusetts, South Carolina, New York, Illinois, Texas, Alabama, Oklahoma, Georgia, Nebraska, Florida, Missouri, California, Colorado, New Mexico, Arkansas, Wyoming, Kansas, Pennsylvania, Washington, Montana, and Arizona.

The recalled product

Product
The Steripath Gen2 Blood Collection System Model Number/Description 2700-21-EN / Steripath Gen2 Blood Collection System - 21G, Wide Neck 2700-23-EN / Steripath Gen2 Blood Collection System - 23G, Wide Neck 27BD-21-EN / Steripath Gen2 Blood Collection System - 21G, Long Neck
Manufacturer
Magnolia Medical Technologies, Inc.
Hazard
  • premature-needle-retraction
  • needlestick-risk

Distribution

Distributed nationwide across the United States.