CLASS II Device recall · Reported 27 Jun 2012 · FDA Enforcement Report
TX1 Tissue Removal System Console recalled by American Optisurgical
American Optisurgical is recalling TX1 Tissue Removal System Console, distributed nationwide in the US. The recall was initiated on 22 Feb 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1817-2012
- FDA event ID
- 61253
- Recalling firm
- American Optisurgical, Lake Forest, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Feb 2012
- FDA classified
- 15 Jun 2012
- Reported
- 27 Jun 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Hip & Knee Implants
Timeline
| 22 Feb 2012 | Recall initiated by company | |
| 15 Jun 2012 | Classified by FDA | +114 days |
| 27 Jun 2012 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Two reasons for recall. 1. Incorrect pressure relief valve installed inside console, leading to a remote chance of a risk to health. 2. Technical Specifications, under Irrigation, the Operating Pressure value is incorrect.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
TX1 Tissue Removal System Console. Model: TX1 TX1 Tissue Removal System is an ultrasonic aspirator that emulsifies and removes soft tissue. The TX1 Console provides control over each mode of operation, as well as the user interface via LCD touchscreen and audible tones for confirmation of user selections. Indiciated 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.
Where it was distributed
Nationwide distribution: MN only.
Questions about this recall
Is TX1 Tissue Removal System Console recalled?
Yes. American Optisurgical recalled TX1 Tissue Removal System Console on 22 Feb 2012. The recall is Class II and its status is Terminated. Recall number Z-1817-2012.
Why was it recalled?
Two reasons for recall. 1. Incorrect pressure relief valve installed inside console, leading to a remote chance of a risk to health. 2. Technical Specifications, under Irrigation, the Operating Pressure value is incorrect.
Which lots are affected?
Product Codes: LFL, GEI, Serial #: 55400001, 55400002, 55400003. Part Order No: 554-0034-000 510(K) Mp.: K101561
Where was it sold?
Nationwide distribution: MN only.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from American Optisurgical
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | TX1 Tissue Removal System disposable handpieces recalled | American Optisurgical | Foreign Material | Nationwide |
| Device | CLASS II | TX1 Tissue Removal System Console recalled by American Optisurgical | American Optisurgical | Packaging Defects | 31 states |
| Device | CLASS II | FAST Procedure Kit recalled by American Optisurgical | American Optisurgical | Sterility | Nationwide |
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