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Lower risk Medical device recall · FDA · Published April 24, 2023

Avanos ambIT System: Potential air filter missing in some kits

Avanos Medical recalls ambIT System kits (Product Code 220509) due to potential absence of air in-line filter. Affected kits have specific lot numbers from Dec 2023.

🇺🇸 FDA recall #Z-1684-2023Medical deviceAvanos Medical ›
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Recalling firmAvanos Medical, Inc.5405 Windward Pkwy · Alpharetta, GA 30004-3894
✎ GovInfoNow plain-language explainer

Avanos Medical is recalling some ambIT System kits that may have been distributed without an air in-line filter. This could pose a risk of air entering the system during use, potentially causing complications. Read more at govinfonow.com/recall/58507-avanos-ambit-system-potential-air-filter-missing-in-some-kits.

Source Summary by GovInfoNow · govinfonow.com/recall/58507-avanos-ambit-system-potential-air-filter-missing-in-some-kits · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1684-2023

Cite this page

“Avanos ambIT System: Potential air filter missing in some kits.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58507-avanos-ambit-system-potential-air-filter-missing-in-some-kits. Based on FDA recall #Z-1684-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1684-2023%22&limit=1).

Avanos Medical, Inc. recalled AVNS ambIT System - PIB/PCA W 2.5in Cath kits on April 24, 2023, according to the FDA. The hazard is that some kits were distributed without an air in-line filter. The recall involves lots 30181360 and 30177648.

How to tell if you have it

  • Brand: Avanos Medical
  • Product: AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509
  • Lot Number (Expiration Date): 30181360 (17 Dec 2023)
  • Lot Number (Expiration Date): 30177648 (17 Dec 2023)

The hazard

Some of the ambIT kits were potentially distributed without an air in-line filter. 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 include the PEG Kit with ENFit Connectors Lidocaine Quality Issue Recall (April 30, 2026), Ballard Closed Suction Catheters Recall (March 19, 2025), and MIC-KEY Gastric-Jejunal Feeding Tube Kit Recall (May 31, 2024).

How to tell if you have this one

Check for Product Code 220509 on the kit. Affected kits have lot numbers 30181360 or 30177648 with expiration dates of December 17, 2023.

  • Brand
    Avanos Medical
  • Category
    Medical device
FDA recall event · 5 products

All 5 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    Worldwide distribution - US Nationwide distribution in the states of Texas and Oregon. The country of Australia.
Recall numberProduct, codes & lotsQuantity
Z-1684-2023AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509; Lot Number (Expiration Date): 30181360 (17 Dec 2023), 30177648 (17 Dec 2023)33 cases (165 cassettes)
Z-1685-2023AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507; Lot Number (Expiration Date): 30177647 (17 Dec 2023); 30174128 (14 Oct 2023)57 cases (285 cassettes)
Z-1686-2023SMMT ambIT Kit Basic Filter Luer Cass, Product Code: 220537; Lot Number (Expiration Date): 30195563 (17 Jan 2025); 30190578 (17 Jan 2025)45 cases (225 cassettes)
Z-1687-2023SMMT ambIT Reusable Program - Luer Cass, Product Code: 220568; Lot Number (Expiration Date): 30191805 (17 Jan 2025)40 cases (200 cassettes)
Z-1688-2023ambIT Cassette Filter Male Luer, Product Code: 220266; Lot Number (Expiration Date): F201701 (17 Jan 2025)1155 total, 280 individually packaged
Based on the official FDA remedy

What to do — step by step

  1. Check Kit Details

    Verify the Product Code and lot numbers on the ambIT System kit to determine if it is affected.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 2 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: named in the noticeORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: nationwideFL

FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of Texas and Oregon. The country of Australia.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Oregon, Texas.

Recall timeline

FDA terminated this recall 15 months after the firm started it.

1. Firm started the recall: Apr 24, 202312. FDA classified it Class II: Jun 6, 202323. Published in FDA’s Enforcement Report: Jun 14, 202334. FDA terminated the recall: Aug 2, 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.

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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-1684-2023 (April 24, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1684-2023 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