The Recall Desk

Manufacturer

American Optisurgical Inc

4 recalls in our database name American Optisurgical Inc as the manufacturing or recalling firm.

What the numbers show

Total
4
Critical
0
Severe
0
Most recent
2013-06-19

Of the 4 recalls from American Optisurgical Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–4 of 4

  • ModerateFDA (Devices)·Z-1518-2013·2013-06-19

    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.

    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1516-2013·2013-06-12

    American Optisurgical Recalls TX1 Tissue Removal System Consoles

    American Optisurgical is recalling 194 TX1 Tissue Removal System Consoles due to a defect in the overheating protection circuit that may cause the device to lose power during use.

    Product
    American Optisurgical's TX1 Tissue Removal System Console. The console is a software unit that is indicated for use in surgical procedures.
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Devices)·Z-1505-2013·2013-06-12

    American Optisurgical Recalls ChloraPrep Applicators Due to Seal Defect

    American Optisurgical is recalling ChloraPrep Hi-Lite Orange 3mL Applicators because an incomplete seal on the packaging may have compromised sterility assurance.

    Product
    FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1817-2012·2012-06-27

    American Optisurgical Recalls TX1 Tissue Removal System Consoles

    American Optisurgical Inc is recalling five TX1 Tissue Removal System Consoles due to an incorrect pressure relief valve and inaccurate technical specifications.

    Product
    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 confi
    Category
    Medical Device
    Distribution
    Distributed nationwide