RegWardenFDA facility compliance records
Recall

Class II — Abbott

Recalling firmABBOTT LABORATORIES
Registered facilityView this company's 64 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusOngoing
ReasonCertain NT2000iX RF generators were serviced using a tool that was subsequently found to be out of tolerance and therefore may not have provided accurate results for potential capacitance failure.
ProductAbbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator
Quantity34 devices
DistributionUS, Taiwan, and Colombia
Initiated2023-09-28
Classified2023-11-02
Recall numberZ-0209-2024
InitiationVoluntary: Firm initiated

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

Cite this record

RegWarden. “Class II recall — Abbott (Z-0209-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93152/

Not open yet

Alerts for ABBOTT LABORATORIES

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.