DePuy Mitek Recalls VAPR Tripolar Suction Electrodes Due to Button Color Error
DePuy Mitek is recalling 127 VAPR Tripolar 90 Degree Suction Electrodes because the ablation and coagulation buttons are colored incorrectly. The wiring is correct, and the issue affects button color only.
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. The hazard is a cosmetic labeling error (button color) with confirmed correct wiring, fitting the rubric for minor labeling errors or low-risk issues without reported injury.
Plain-English summary
DePuy Mitek, Inc., a Johnson & Johnson Co., is recalling 127 units of VAPR Tripolar 90 Degree Suction Electrodes (Model/Catalog No: 225028). The recall was initiated because the ablation and coagulation buttons on the devices are colored incorrectly.
The company confirmed that the wiring for each button function is correct. The non-conformance is limited to the button color and does not impact the electrical functionality of the device. The affected units were distributed worldwide, including in the US states of AL, CA, CT, FL, KY, MN, MS, ND, NJ, NM, and TX, as well as in France, the Netherlands, and Norway. The specific lot codes involved are U1509202 and U1509162.
Healthcare providers and consumers should stop using these specific devices and contact DePuy Mitek for instructions on return or replacement. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- VAPR¿ TRIPOLAR 90" Degree Suction Electrodes (Model/Catalog No: 225028)
- Manufacturer
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Hazard
- Affected units
- 127
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)
- U1509202 and U1509162
Distribution
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