CLASS II Device recall · Reported 14 Jun 2017 · FDA Enforcement Report

Oxygen Masks, Elongated (under chin), Adult Med Conc. recalled

ConvaTec is recalling Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, distributed in 14 states. The recall was initiated on 10 May 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number 102153, 102339, 102941, 103176, 103453, 103718, 103919, 104471, 105034, 105282, 105427, 105567, 105996, 106960, 108658, 112024, 112530

Quantity recalled816,709

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-2228-2017
FDA event ID: 77282
Recalling firm: ConvaTec, Greensboro, NC
Classification: Class II
Status: Terminated
Recall initiated: 10 May 2017
FDA classified: 2 Jun 2017
Reported: 14 Jun 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Masks, Gloves & PPE

Timeline

10 May 2017	Recall initiated by company
2 Jun 2017	Classified by FDA	+23 days
14 Jun 2017	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

Reports of tubing detaching from oxygen masks either prior to use (in packaging) or during use were made by different end users and for different batches. The failures were caused by an improper solvent bond between the oxygen tubing and the oxygen mask connector. While the defect affects less than 2% of recalled product, there is a potential for harm when oxygen supply to the user is disrupted.

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

Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Code 104-E;

Where it was distributed

CA, CT, FL, GA, IL, MO, NJ, NY, NC, OH, PA, RI, VA , Puerto Rico, Australia, Belgium, Canada, Columbia, Czech, Denmark, Finland, France, Germany, Greece, Israel, Italy, Japan, Jordan, Malaysia, Malta, Netherlands, Norway, Rwanda, Saudi Arabia, Sweden, Switzerland, United Kingdom, and Vietnam

California Connecticut Florida Georgia Illinois Missouri North Carolina New Jersey New York Ohio Pennsylvania Puerto Rico Rhode Island Virginia

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot Number 102153, 102339, 102941, 103176, 103453, 103718, 103919, 104471, 105034, 105282, 105427, 105567, 105996, 106960, 108658, 112024, 112530

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.

Other products in this recall event

17 other products · FDA event 77282

This product is part of a recall event; the main page for the event is Non-Rebreather Oxygen Mask, Adult High Concentration recalled.

Reported	Class	Recall	Company	Reason	Where
14 Jun 2017	CLASS II	Non-Rebreather Oxygen Mask, Adult High Concentration recalled	ConvaTec	Other	14 states
14 Jun 2017	CLASS II	Oxygen Masks, Elongated (Under Chin) recalled by ConvaTec	ConvaTec	Other	14 states
14 Jun 2017	CLASS II	Oxygen Mask, Elongated (Under the Chin) Pediatric recalled by ConvaTec	ConvaTec	Other	14 states
14 Jun 2017	CLASS II	Non-Rebreathing Mask, Reservoir, Check Valve recalled by ConvaTec	ConvaTec	Other	14 states
14 Jun 2017	CLASS II	Oxygen Masks, Elongated (Under Chin) Adult High Conc. recalled	ConvaTec	Other	14 states
14 Jun 2017	CLASS II	Oxygen Mask, Standard (Under the Lip) Infant recalled by ConvaTec	ConvaTec	Other	14 states
14 Jun 2017	CLASS II	Non-Rebreather Mask, Reservoir, Check Valve recalled by ConvaTec	ConvaTec	Other	14 states
14 Jun 2017	CLASS II	Oxygen Mask, Elongated (Under the Chin) Pediatric recalled by ConvaTec	ConvaTec	Other	14 states
14 Jun 2017	CLASS II	Non-Rebreather, Oxygen Mask, Adult 7 (2.1 m) Tubing, Product recalled	ConvaTec	Other	14 states
14 Jun 2017	CLASS II	Non-Rebreather Mask w 7 (2.1 m) No-Crush Tubing, Adult, Product recalled	ConvaTec	Other	14 states
14 Jun 2017	CLASS II	Pediatric, High Conc recalled by ConvaTec	ConvaTec	Other	14 states
14 Jun 2017	CLASS II	Rebreathing Mask, Reservoir, with Tubing, Product recalled by ConvaTec	ConvaTec	Other	14 states
14 Jun 2017	CLASS II	Oxygen Mask, Adult High Concentration Non-Rebreather 2.1 m recalled	ConvaTec	Other	14 states
14 Jun 2017	CLASS II	Non-Rebreather Oxygen Mask, Pediatric with Tubing, Product recalled	ConvaTec	Other	14 states
14 Jun 2017	CLASS II	Rebreather Oxygen Mask, Adult 7 (2.1 m) Tubing, Product recalled	ConvaTec	Other	14 states
14 Jun 2017	CLASS II	Oxygen Masks, Elongated (Under Chin), Adult High Conc. recalled	ConvaTec	Other	14 states
14 Jun 2017	CLASS II	Non-Rebreathing Mask, Reservoir, Check Valve recalled by ConvaTec	ConvaTec	Other	14 states

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