The Recall Desk
ModerateFDA (Devices)·Z-1518-2013·Announced 2013-06-19

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.

What this means for you

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, Laparoscop
Manufacturer
American Optisurgical Inc
Category
Medical Device — Surgical Instruments
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

Distributed nationwide across the United States.

The notice also names 39 states specifically:

Related recalls

Same manufacturer · American Optisurgical Inc

See all →

Same hazard · device underperformance

See all →