CLASS II Device recall · Reported 9 May 2018 · FDA Enforcement Report

Teleflex Medical Lma(TM) MADgic(TM) Laryngo-tracheal recalled

Teleflex Medical Europe is recalling Teleflex Medical Lma(TM) MADgic(TM) Laryngo-tracheal Mucosal Atomization Device, MAD700, distributed in Texas. The recall was initiated on 19 Mar 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number 161212

Quantity recalled25 units

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-1628-2018
FDA event ID: 79643
Recalling firm: Teleflex Medical Europe, Athlone, N/A
Classification: Class II
Status: Terminated
Recall initiated: 19 Mar 2018
FDA classified: 3 May 2018
Reported: 9 May 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Masks, Gloves & PPE

Timeline

19 Mar 2018	Recall initiated by company
3 May 2018	Classified by FDA	+45 days
9 May 2018	Published in enforcement report	+6 days

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

Reason for recall

Teleflex Medical is recalling the affected product because there may be missing or incomplete information on the package label.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Teleflex MEDICAL LMA(TM) MADgic(TM) LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE, MAD700, QTY: 1 Intended for the application of topical anesthetics to the oropharynx and upper airway region

Where it was distributed

Texas

Questions about this recall

Why was it recalled?

Teleflex Medical is recalling the affected product because there may be missing or incomplete information on the package label.

Which lots are affected?

Lot Number 161212

Where was it sold?

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

More recalls from Teleflex Medical Europe

All 11

Reported	Class	Recall	Company	Reason	Where
25 Aug 2021Device	CLASS II	Rusch Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal recalled	Teleflex Medical Europe	Other	Nationwide
25 Aug 2021Device	CLASS II	Rusch Endotracheal Tube oral/nasal Magill, High Volume recalled	Teleflex Medical Europe	Other	Nationwide
25 Aug 2021Device	CLASS II	Rusch Endotracheal Tube oral/nasal Murphy Eye, High Volume recalled	Teleflex Medical Europe	Other	Nationwide
25 Aug 2021Device	CLASS II	Rusch Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal recalled	Teleflex Medical Europe	Other	Nationwide
4 Jul 2018Device	CLASS II	Teleflex Medical Pilling(R) Universal Shears 7 1/2" recalled	Teleflex Medical Europe	Foreign Material	Nationwide

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