Tenex TX1 Tissue Removal System Recalled for Packaging Defect
Tenex Health Inc is recalling TX1 Tissue Removal Systems because cracks in the packaging may compromise the sterile barrier during transport in extreme cold.
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 involves a potential loss of sterility due to packaging defects under specific transport conditions, which fits the criteria for moderate severity without reported injuries.
Plain-English summary
Tenex Health Inc is recalling the TX1 Tissue Removal System, including the TX1 Procedure Pack and TX1 MicroTip, used with the TX System Console as an ultrasonic surgical aspirator of soft tissue. The recall involves 9,927 units distributed nationwide in the United States and internationally to Panama and Singapore.
The recall is due to a potential defect in the sterile barrier of the packaging. Cracks in the thermoform tray may occur during transport in extreme cold weather conditions combined with mechanical impact, which could compromise the sterility of the device.
Healthcare facilities and consumers should stop using the affected products and contact Tenex Health Inc for further instructions or a return. The specific lot numbers affected are listed in the official recall documentation.
The recalled product
- Product
- TX1 Tissue Removal System. TX1 Procedure Pack P/N 554-1003-001 (outer box), TX1 MicroTip P/N 554-1002-001 (inner tray). For use with the TX System Console as an ultrasonic surgical aspirator of soft tissue.
- Manufacturer
- Tenex Health Inc
- Affected units
- 9,927
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 (20)
- Lot Numbers: 00614-03
- 06513-02
- 24913-01
- 00713-06
- 06514-02
- 25313-01
- 00814-02
- 06914-01
- 25513-02
- 01114-02
- 07213-04
- 25613-01
- 01514-03
- 07713-18
- 26113-06
- 01714-04
- 08113-04
- 26313-04
- 01813-02
- 08413-13
Distribution
Distributed nationwide across the United States.
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