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Lower risk Medical device recall · FDA · Published February 3, 2023

Avanos Oral Care Swabs: Incorrect Expiration Date Recall

Recall of Avanos Ballard Oral Care Swabs with incorrect expiration dates. Product codes 12241, 12243, 12251 affected. Check lot numbers for affected items.

🇺🇸 FDA recall #Z-1406-2023Medical deviceAvanos ›
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Recalling firmAvanos Medical, Inc.5405 Windward Pkwy · Alpharetta, GA 30004-3894
✎ GovInfoNow plain-language explainer

Avanos Medical recalls certain bulk packs of Ballard Oral Care Swabs due to incorrect expiration dates. Using these swabs could lead to product spoilage or potential safety issues if expired. Read more at govinfonow.com/recall/58960-avanos-oral-care-swabs-incorrect-expiration-date-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/58960-avanos-oral-care-swabs-incorrect-expiration-date-recall · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1406-2023

Cite this page

“Avanos Oral Care Swabs: Incorrect Expiration Date Recall.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/58960-avanos-oral-care-swabs-incorrect-expiration-date-recall. Based on FDA recall #Z-1406-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1406-2023%22&limit=1).

Avanos Medical, Inc. recalled Avanos Ballard Oral Care Swab, Bulk Packed on Feb. 3, 2023, due to an incorrect expiration date, according to the FDA. The Food and Drug Administration announced the Class II recall of product codes 12241, 12243, and 12251.

How to tell if you have it

  • Avanos Ballard Oral Care Swab, Bulk Packed
  • Product Code 12241
  • Product Code 12243
  • Product Code 12251

The hazard

The recalled swabs have an incorrect expiration date. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Avanos Medical, Inc. has 18 other recalls on record since Oct. 8, 2019. Other recent recalls of similar products include Cook Medical Pneumothorax Tray Recall (March 5, 2026), Cook Medical Multipurpose Drainage Catheter Recall (March 5, 2026), and B Braun Discofix Four Way Stopcock Recall (Aug. 4, 2026). Avanos Medical previously recalled Ballard Closed Suction Catheters for lack of sterility assurance on March 19, 2025.

How to tell if you have this one

Check the product code (12241, 12243, or 12251) and lot numbers listed in the recall notice. The affected swabs were sold between 2005 and 2009.

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

What to do — step by step

  1. Check Product Code

    Identify if your swab package has product codes 12241, 12243, or 12251.

  2. Verify Lot Numbers

    Check the lot numbers against the list provided in the recall notice to confirm if your swabs are affected.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Worldwide distribution - US Nationwide and the countries of Canada, Germany, Netherlands, France, Switzerland, Great Britain, Israel, and India.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 18 months after the firm started it.

1. Firm started the recall: Feb 3, 202312. FDA classified it Class II: Apr 19, 202323. Published in FDA’s Enforcement Report: Apr 26, 202334. FDA terminated the recall: Aug 19, 2024420232024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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

✎ GovInfoNow

Questions people ask

Do I need to throw out the swabs?

The recall does not require discarding the swabs; you can check the lot numbers to determine if they are affected.

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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-1406-2023 (February 3, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1406-2023 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 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