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.
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 3/5 (High).
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…
- Manufacturer
- Magnolia Medical Technologies, Inc.
- Affected units
- 137,200
Distribution
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