Sterilmed Recalls Reprocessed EP Ablation Cables Due to Regulatory Status
Sterilmed is recalling 963 reprocessed EP ablation cables because they are Class III devices that lack required premarket approval.
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, but the source text does not report any illnesses, injuries, or deaths. The hazard is regulatory (lack of premarket approval) rather than a direct physical defect causing harm, fitting the Moderate category for voluntary precautionary or regulatory recalls without reported harm.
Plain-English summary
Sterilmed Inc is recalling 963 units of reprocessed EP Ablation Cables. The recall covers all lots of specific product codes for these unexpired devices. The cables are designed as electrode cables with a multi-pin connector and serve as extensions or interfaces for electrophysiology catheters.
The recall was initiated because Sterilmed determined that these cables are Class III devices. Class III devices require premarket review and approval by the FDA, which these specific cables do not currently have. The agency classification for this recall is Class II.
The affected devices were distributed in the United States to the states of Alabama, Arkansas, Colorado, Florida, Illinois, Michigan, Missouri, Mississippi, Montana, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, Virginia, Wisconsin, and West Virginia. Users of these devices should contact Sterilmed for further instructions.
The recalled product
- Product
- Electrophysiology catheter cables are designed as electrode cables with a multi-pin connector on the distal end and the appropriate number of tails on the proximal end. The cables serve two different purposes. They either serve as an extension between an EP catheter and…
- Manufacturer
- Sterilmed Inc
- Affected units
- 963
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 (1)
- all lots
Distribution
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