RegWardenFDA facility compliance records
Facility

CLINICAL INNOVATIONS, LLC

6 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2014: 1 recalls; 2015: 1 recalls; 2019: 2 recalls, 1 inspections; 2020: 1 recalls; 2026: 1 recalls1’141’15’16’17’183’191’20’21’22’23’24’251’26
  • Recalls (6)
  • Inspections (1)

Devices registered here (1)

  • Cannula, Manipulator/Injector, Uterine
    Product code LKF (opens in a new tab) · Class II · Obstetrics/Gynecology · 21 CFR 884.4530

Recalls & enforcement

  • Class IIOngoing2026-03-09
    Due to complaints of device breakage at the traction force gauge to handle joint.
  • Class IITerminated2020-08-13
    Possible false negative or false positive results. The incorrect sample collection swabs (non-scored) were assembled into assembled into the in vitro diagnostic kits. If the user does not break the swab stick correctly, or if scissors or other tools are used to cut the swab ha…
  • Class IITerminated2019-08-06
    There is a potential for loss of vacuum or failure to generate vacuum when using the firm's fetal vacuum delivery system.
  • Class IITerminated2019-05-30
    An incorrect component used during manufacturing. The uterine manipulator tip support does not have the "notch" required to attach the spacer and or colpotomy cup. This may result in a delay in surgery and additional surgical interventions to completed the procedure. There was a …
  • Class IITerminated2015-01-05
    Clinical Innovations, LLC is voluntarily recalling the Ebb Complete Tamponade System (CTS-1000) Lot Number 1214-F-403.) to address the potential for a balloon leak which may affect the ability to deliver therapy, when needed.
  • Class IITerminated2014-12-30
    Potential for a balloon leak in all lots of (CTS-1000) manufactured since August 2014.

FDA inspections (1)

  • NAI2019-03-15
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “CLINICAL INNOVATIONS, LLC (FEI 1000220650) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000220650-clinical-innovations-llc/

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