RegWardenFDA facility compliance records
Recall

Class II — Covidien, LLC

Recalling firmCovidien llc
Registered facilityView this company's 22 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusOngoing
ReasonThe product is labeled with the incorrect expiration date.
ProductCOVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, REF CA108L1
Quantity21 units
DistributionForeign Distribution: Hong Kong
Initiated2022-11-23
Classified2023-01-12
Recall numberZ-0955-2023
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 — Covidien, LLC (Z-0955-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91318/

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