Reported Apr 20, 2022 · Terminated

Medline Standard PVC Laryngeal Masks, 1 device per pouch, 5 each pouches per box

MEDLINE INDUSTRIES, LP - Northfield

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: MEDLINE INDUSTRIES, LP - Northfield · 3 Lakes Dr · Northfield, IL · 60093-2753

Is this the product you have?

    • Medline Standard PVC Laryngeal Masks
    • 1 device per pouch
    • 5 each pouches per box
Lot codes and dates

7 of 7 products

Products covered by this recall
#BarcodesProduct as published
110193489036688DYND290010; Lot 63521050001 (UDI: 10193489036688)
210193489036695DYND290015; Lot 63521050001 (UDI: 10193489036695)
310193489036701DYND290020; Lots 63521050001, 63521110001, and 63521100002 (UDI: 10193489036701)
410193489036718DYND290025; Lots 63521050001, 63521110001, and 63521100002 (UDI: 10193489036718)
510193489036725DYND290030; Lots 63521050001, 63521100002, 63521050002, and 63521110001 (UDI: 10193489036725)
610193489036732DYND290040; Lots 63521050001, 63521100002, 63521050002, and 63521110001 (UDI: 10193489036732)
710193489036749DYND290050; Lots 63521050001, 63521110001, and 63521100002 (UDI: 10193489036749)
Amount recalled
8990 cases

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

  • Nationwide

Why it was recalled

The mask cuff may disconnect from the device's breathing tube.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 26, 2026 · Data as of Sep 19, 6:56 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.