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Lower risk Medical device recall · FDA · Published January 15, 2019

Westmed Neo-Vent Infant T-Piece Circuit Recall: 15mm OD Connection Issue

Westmed recalls Neo-Vent Infant T-Piece Resuscitation Circuits with 15mm OD connections that may not fit infant resuscitators. Affected units have specific model numbers and were sold in 2018.

🇺🇸 FDA recall #Z-2435-2020Medical deviceWestmed ›
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Recalling firmWestmed, Inc.5580 S Nogales Hwy Ste 170 · Tucson, AZ 85706-3333
✎ GovInfoNow plain-language explainer

Westmed is recalling Neo-Vent Infant T-Piece Resuscitation Circuits that have a connection issue. The problem means some hospitals can't use these circuits with their infant resuscitators because the connections don't match. Read more at govinfonow.com/recall/69116-westmed-neo-vent-infant-t-piece-circuit-recall-15mm-od.

Source Summary by GovInfoNow · govinfonow.com/recall/69116-westmed-neo-vent-infant-t-piece-circuit-recall-15mm-od · Updated August 20, 2026 · FDA enforcement record: FDA #Z-2435-2020

Cite this page

“Westmed Neo-Vent Infant T-Piece Circuit Recall: 15mm OD Connection Issue.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69116-westmed-neo-vent-infant-t-piece-circuit-recall-15mm-od. Based on FDA recall #Z-2435-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2435-2020%22&limit=1).

The FDA announced on Jan. 15, 2019, that Westmed, Inc. recalled Neo-Vent Infant T-Piece Resuscitation Circuits with infant masks due to non-compliant connections. The hazard prevents use with certain infant resuscitators.

How to tell if you have it

  • Brand: Westmed
  • Product: Neo-Vent Infant T-Piece Resuscitation Circuit With Infant Mask
  • REF: 0420
  • Lot codes: 101618U02, 102318U06, 101518U03
  • Quantity: 35 cases

The hazard

A repair to an adapter mold resulted in parts with non-compliant 15mm OD connections. This prevents facilities using infant resuscitators that connect via the 15mm OD fitting from using the circuits.

Context

GovInfoNow's records show Westmed, Inc. has two other recalls on record since Nov. 11, 2020. On Sept. 27, 2024, Westmed issued a recall for Flex Extenders due to the risk of life-threatening disconnection. On Nov. 11, 2020, Westmed recalled Adult Elongated O2/CO2 Masks because of loose connection risks. Other recent recalls of similar products include Medline Breathing Circuits Recall (July 13, 2026) and Medline Hudson RCI Breathing Circuits Recall (July 13, 2026).

How to tell if you have this one

Check for model numbers 101618U02, 102318U06, or 101518U03 on the circuit. These units were sold in 2018 with a 15mm OD x 10mm ID connector.

  • Brand
    Westmed
  • Category
    Medical device
FDA recall event · 3 products

All 3 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 including in the states of CA, GA, IL,OH, MA, MI, MO, NC, OH, OR, TX, VA, and WI. The country of Spain.
Recall numberProduct, codes & lotsQuantity
Z-2434-2020Neo-Vent Infant T-Piece Resuscitation Circuit;Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0415, Qty:10, Length: 60" (1.5cm), Rx Only.; 101118T42, 101118T44, 102918T01, 080618T02, 080618T03 , 101118T43, 102918T02.625 cases
Z-2435-2020Neo-Vent Infant T-Piece Resuscitation Circuit With Infant Mask; Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0420, Qty:10, Length: 60" (1.5cm), Rx Only.; 101618U02, 102318U06, 101518U03.35 cases
Z-2436-2020Neo-Vent Infant T-Piece Resuscitation Circuit With Neonatal Mask; Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0421, Qty:10, Length: 60" (1.5cm), Rx Only.; 101518U04, 102318U07, 101618U03.48 cases
Based on the official FDA remedy

What to do — step by step

  1. Check Model Numbers

    Look for model numbers 101618U02, 102318U06, or 101518U03 on the circuit.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 12 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: named in the noticeOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: nationwideFL

FDA distribution: “Worldwide distribution - US Nationwide distribution including in the states of CA, GA, IL,OH, MA, MI, MO, NC, OH, OR, TX, VA, and WI. The country of Spain.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Georgia, Illinois, Massachusetts, Michigan, Missouri, North Carolina, Ohio, Oregon, Texas, Virginia, Wisconsin.

Recall timeline

FDA terminated this recall 2.1 years after the firm started it.

1. Firm started the recall: Jan 15, 201912. FDA classified it Class II: Jun 26, 202023. Published in FDA’s Enforcement Report: Jul 8, 202034. FDA terminated the recall: Feb 5, 2021420192021
  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

Are there any safety risks?

The issue only affects specific circuits and does not cause immediate injury. Facilities can still use the circuits if they have compatible resuscitators.

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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-2435-2020 (January 15, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2435-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on August 20, 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