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Unrated Medical device recall · FDA · Published August 1, 2023

Avanos COOLIEF RF Generator F100/F101 Faults: Stop Using Now

Avanos recalls COOLIEF RF Generators with F100/F101 faults. These devices may cause system errors. Stop using immediately to avoid potential issues.

🇺🇸 FDA recall #Z-2622-2023Medical deviceAvanos ›
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Contact the company

Recalling firmAvanos Medical, Inc.5405 Windward Pkwy · Alpharetta, GA 30004-3894
✎ GovInfoNow plain-language explainer

Avanos is recalling COOLIEF RF Generators that have been reported to produce F100 and F101 faults. These faults could lead to system errors that might affect safe medical use. Read more at govinfonow.com/recall/57555-avanos-coolief-rf-generator-f100-f101-faults-stop-using-now.

Source Summary by GovInfoNow · govinfonow.com/recall/57555-avanos-coolief-rf-generator-f100-f101-faults-stop-using-now · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2622-2023

Cite this page

“Avanos COOLIEF RF Generator F100/F101 Faults: Stop Using Now.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57555-avanos-coolief-rf-generator-f100-f101-faults-stop-using-now. Based on FDA recall #Z-2622-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2622-2023%22&limit=1).

Avanos Medical, Inc. recalled COOLIEF RF Generators on Aug. 1, 2023, after receiving increased complaints of F100 and F101 faults, the FDA said. The recall involves 24 units distributed in the U.S. and Brazil.

How to tell if you have it

  • Brand: Avanos
  • Product: COOLIEF RF Generator
  • Lot codes: STZ22277-006 through STZ22277-029, STZ22318-001

The hazard

The FDA said Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults. The record does not report specific incidents or injuries.

Context

GovInfoNow's records show Avanos Medical, Inc. has 18 other recalls on record since Oct. 8, 2019. Recent brand recalls include the PEG Kit 24 Fr PULL recall on April 30, 2026, and the Ballard Closed Suction Catheters Recall on March 19, 2025. Other recent recalls of similar products include Philips Allura Xper FD10F Medical System Recall (Dec. 15, 2025), Philips Allura Xper FD10C Medical System Recall (Dec. 15, 2025), and Philips Allura Xper FD20 Medical System Recall (Dec. 15, 2025).

How to tell if you have this one

Check for model numbers STZ22277-006 through STZ22318-001 on the device. These COOLIEF RF Generators are used in medical procedures and may have faults.

  • Brand
    Avanos
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Stop Using Immediately

    The device may produce F100 and F101 faults that could cause system errors during medical procedures.

Where it went and when

Where it was distributed

Distributed in 16 states, and outside the U.S.

Alaska: not listedAKMaine: not listedMEVermont: yesVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: yesMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: yesNYRhode Island: not listedRIMassachusetts: not listedMAOregon: yesORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: yesCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: yesVAMaryland: not listedMDDelaware: not listedDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: not listedARTennessee: not listedTNNorth Carolina: yesNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: yesLAMississippi: not listedMSAlabama: not listedALGeorgia: yesGAHawaii: not listedHITexas: yesTXFlorida: not listedFL

FDA distribution: “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” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arizona, California, Georgia, Indiana, Iowa, Kansas, Louisiana, Minnesota, New Mexico, New York, North Carolina, Ohio, Oregon, Texas, Vermont, Virginia.

Recall timeline

FDA published this recall 57 days after the firm started it.

1. Firm started the recall: Aug 1, 202312. FDA classified it Class II: Sep 21, 202323. Published in FDA’s Enforcement Report: Sep 27, 202332023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2622-2023 (August 1, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2622-2023 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA