The Recall Desk
HighFDA (Devices)·Z-2233-2017·Announced 2017-06-14

ConvaTec Recalls Non-Rebreather Oxygen Masks Due to Quality Concerns

ConvaTec, Inc. is voluntarily recalling specific lots of Non-Rebreather Oxygen Masks. The recall was initiated due to quality concerns, though no specific defect is described in the source.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, which indicates a situation that could cause temporary or medically reversible health consequences. As no specific injuries or illnesses are reported in the source, it falls under the 'High' severity category for risk-of-harm products where injury has not yet been reported.

Plain-English summary

ConvaTec, Inc. has voluntarily initiated a Class II recall of Non-Rebreather Oxygen Masks, Adult High Concentration with 2.1 m (7) Oxygen Tubing, Product Code 108MM. The recall covers specific lot numbers: 100281, 100709, 100729, 101923, 103180, 103265, 103691, 103714, 104104, 105987, and 110558. The recall was initiated on May 10, 2017, and was terminated on August 27, 2021.

The source text does not specify the exact reason for the recall or the nature of the defect, stating only that it was a voluntary, firm-initiated action. The affected products were distributed in numerous U.S. states, including California, Connecticut, Florida, Georgia, Illinois, Missouri, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, and Virginia, as well as Puerto Rico and multiple international locations.

Consumers and healthcare providers should check the lot numbers on their oxygen masks to see if they are affected. If a mask is included in this recall, users should stop using it and contact ConvaTec, Inc. for instructions on return or replacement. The recall status is currently listed as Terminated.

The recalled product

Product
Non-Rebreather Oxygen Mask, Adult High Concentration with 2.1 m (7) Oxygen Tubing, Product Code 108MM
Manufacturer
ConvaTec, Inc
Category
Medical Device — Respiratory Equipment
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (11)

  • Lot Number 100281
  • 100709
  • 100729
  • 101923
  • 103180
  • 103265
  • 103691
  • 103714
  • 104104
  • 105987
  • 110558

Distribution

Distributed in 14 states:

Part of a larger recall action

This product is one of 18 recalled by ConvaTec, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 18 products in this recall →

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