American Optisurgical Recalls TX1 Tissue Removal System Handpieces
American Optisurgical is recalling TX1 Tissue Removal System disposable handpieces because they were distributed without a cleared FDA 510(k) for recent product changes.
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 source text explicitly states that no illnesses or injuries have been reported, with the hazard being theoretical underperformance.
Plain-English summary
American Optisurgical, Inc. is recalling certain lots of TX1 Tissue Removal System disposable handpieces. The recall is due to inventory being released into distribution without a cleared FDA 510(k) to cover recent product changes.
The TX1 Tissue Removal System is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery, and Plastic and Reconstructive Surgery. The affected units were distributed worldwide, including in the United States and in Quezon City, Philippines, Singapore, and Panama City, Panama.
Use of this product may lead to an underperformance of the device. The source text does not report any specific injuries or illnesses associated with the use of these handpieces.
The recalled product
- Product
- TX1 Tissue Removal System disposable handpieces. Product Usage: The TX1 Tissue Removal System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery…
- Manufacturer
- American Optisurgical Inc
- Hazard
- Affected units
- 1,436
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: 00312-07
- 00713-06
- 00912-01
- 01813-02
- 02413-04
- 03113-02
- 04213-01
- 05113-01
- 05113-02
- 05512-03
- 05713-03
- 06313-05
- 06512-08
- 06513-02
- 07213-04
- 07912-06
- 08212-07
- 09412-03
- 11412-06
- 11612-05
Distribution
Related recalls
Same manufacturer · American Optisurgical Inc
See all →- HighAmerican Optisurgical Recalls TX1 Tissue Removal System Consoles
FDA (Devices) · 2013-06-12
- HighAmerican Optisurgical Recalls ChloraPrep Applicators Due to Seal Defect
FDA (Devices) · 2013-06-12
- HighAmerican Optisurgical Recalls TX1 Tissue Removal System Consoles
FDA (Devices) · 2012-06-27
Same hazard · device underperformance
See all →- HighHowmedica Recalls Radio Capitellum Small Orthopedic Implants Due to Revision Rates
FDA (Devices) · 2018-08-15
- HighHowmedica Recalls Radio Capitellum Small Orthopedic Implants Due to Performance Concerns
FDA (Devices) · 2018-08-15
- HighHowmedica Recalls Stryker Radial Head Implant Assemblies Due to Performance Concerns
FDA (Devices) · 2018-08-15
Similar recalls
- HighAmerican Optisurgical Recalls TX1 Tissue Removal System Consoles
FDA (Devices) · 2012-06-27
- ModerateTenex TX1 Tissue Removal System Recalled for Packaging Defect
FDA (Devices) · 2014-05-14
- LowMicro-Tech Elastic Traction Device Recalled for Regulatory Classification Issues
FDA (Devices) · 2020-11-25
- SevereMedtronic TurboHawk Plus atherectomy system recalled for potential tip detachment
FDA (Devices) · 2022-03-16
- HighApplied Medical Recalls Epix latis GRASPER Due to Tissue Damage Risk
FDA (Devices) · 2020-06-03
- SevereMedtronic TurboHawk Plus Directional Atherectomy System Recalled Due to Design Defect
FDA (Devices) · 2022-03-16