CLASS II ONGOING Device recall · Reported 2 Aug 2023 · FDA Enforcement Report

DYND3000xxP Series - Flexible Laryngeal Mask Airway Packs recalled

MEDLINE INDUSTRIES, LP - Northfield is recalling DYND3000xxP Series - Flexible Laryngeal Mask Airway Packs, distributed nationwide in the US. The recall was initiated on 28 Mar 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll Lots for series since product launch; Model Number (Unique Device Identifier) -DYND300010P (Each level packaging: 10193489010671; Case level packaging: 20193489010678); DYND300015P (Each level packaging: 10193489010688; Case level packaging: 20193489010685); DYND300020P (Each level packaging: 10193489010695; Case level packaging: 20193489010692); DYND300025P (Each level packaging: 10193489010701 Case level packaging: 20193489010708); DYND300030P (Each level packaging: 10193489010718; Case level packaging: 20193489010715); DYND300040P (Each level packaging: 10193489010725; Case level packaging: 20193489010722); DYND300050P (Each level packaging: 10193489010732; Case level packaging: 20193489010739)

Quantity recalled9945 ea

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2227-2023
FDA event ID: 92572
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 28 Mar 2023
FDA classified: 21 Jul 2023
Reported: 2 Aug 2023
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Masks, Gloves & PPE

Timeline

28 Mar 2023	Recall initiated by company
21 Jul 2023	Classified by FDA	+115 days
2 Aug 2023	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The case and each (i.e. packet) labels for the DYND3000xxP series do not include an expiration date, however, the lubricating jelly (MDS032280) included in the DYNDP3000xxP series is labeled with an expiration date.

Product as listed by the FDA

DYND3000xxP Series - Flexible Laryngeal Mask Airway Packs

Where it was distributed

Worldwide distribution - US Nationwide and the country of Bermuda.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

All Lots for series since product launch; Model Number (Unique Device Identifier) -DYND300010P (Each level packaging: 10193489010671; Case level packaging: 20193489010678); DYND300015P (Each level packaging: 10193489010688; Case level packaging: 20193489010685); DYND300020P (Each level packaging: 10193489010695; Case level packaging: 20193489010692); DYND300025P (Each level packaging: 10193489010701 Case level packaging: 20193489010708); DYND300030P (Each level packaging: 10193489010718; Case level packaging: 20193489010715); DYND300040P (Each level packaging: 10193489010725; Case level packaging: 20193489010722); DYND300050P (Each level packaging: 10193489010732; Case level packaging: 20193489010739)

Where was it sold?

Worldwide distribution - US Nationwide and the country of Bermuda.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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