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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92852

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
August 01, 2023
Product types
Device
Classifications
Class II
Statuses
Completed
Recalling firm wording
Avanos Medical, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four independent RF channels, allowing all RF channels to be activated individually or altogether. The system is controlled via a touch screen interface display that includes user controls, alarm messages, and on-screen selection of lesioning modalities.

Z-2622-2023
Recall number
Z-2622-2023
Initiated
August 01, 2023
Classification
Class II
Status
Completed
Recalling firm
Avanos Medical, Inc.
Quantity
24 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults.

Code information

STZ22277-006, STZ22277-007, STZ22277-008, STZ22277-009, STZ22277-010, STZ22277-011, STZ22277-012, STZ22277-013, STZ22277-014, STZ22277-015, STZ22277-016, STZ22277-017, STZ22277-018, STZ22277-019, STZ22277-020, STZ22277-021, STZ22277-022, STZ22277-023, STZ22277-024, STZ22277-025, STZ22277-026, STZ22277-027, STZ22277-028, STZ22277-029, STZ22318-001

Distribution pattern

US Distribution to states of: AZ, CA, GA, IA, IN, KS, LA, MN, NC, NM, NY, OH, OR, TX, VA, VT, and OUS International distribution to country of: BRAZIL

Field note

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