Stryker Recalls Reprocessed Diagnostic Electrophysiology Catheters Due to Mislabeled French Size
Stryker Sustainability Solutions is recalling four reprocessed Daig Steerable and Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters because they may be mislabeled for French size during reprocessing.
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 hazard is a labeling error (mislabeling for French size) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Stryker Sustainability Solutions is recalling four units of reprocessed Daig Steerable and Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters. The affected devices are identified by model numbers 401940 and 402004, with specific serial numbers and manufacturing dates listed in the recall documentation. These diagnostic electrophysiology catheters are used for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures.
The recall was initiated because the electrophysiology catheters may be mislabeled for French size during the reprocessing stage. This labeling error could potentially impact the correct identification and use of the devices in clinical settings.
The recalled devices were distributed in the United States to facilities in Arizona, Minnesota, and Missouri. Healthcare providers and facilities that may have received these specific units should verify their inventory against the provided serial numbers and model information. If the devices are found, they should be removed from service and returned to Stryker Sustainability Solutions according to the instructions provided in the official recall notice.
The recalled product
- Product
- Reprocessed Daig Steerable and Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters Model Numbers: 401940, 402004 UPC Code: 00885825007409 00885825007744 Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit…
- Manufacturer
- Stryker Sustainability Solutions
- Hazard
- Affected units
- 4
Distribution
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