CLASS II Device recall · Reported 6 Jan 2021 · FDA Enforcement Report
Disposable Respiratory Products Non-rebreather Mask recalled by Westmed
Westmed is recalling Westmed Disposable Respiratory Products Non-rebreather Mask, distributed nationwide in the US. The recall was initiated on 11 Nov 2020 and the FDA has classified it as Class II.
Check your package
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-0742-2021
- FDA event ID
- 86903
- Recalling firm
- Westmed, Tucson, AZ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Nov 2020
- FDA classified
- 29 Dec 2020
- Reported
- 6 Jan 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- CPAP & Ventilators
Timeline
| 11 Nov 2020 | Recall initiated by company | |
| 29 Dec 2020 | Classified by FDA | +48 days |
| 6 Jan 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection to the mask adapter resulting in a possible delay in treatment.
Product as listed by the FDA
Westmed DISPOSABLE RESPIRATORY PRODUCTS NON-REBREATHER MASK, REF 3228-e, RX Only, CE0482, (01)10709078008020 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.
Where it was distributed
Worldwide distribution - US Nationwide distribution including in the states of PA, OK, MO, CO, RI, IL, CA, TX, OH, MD, IL, MN, KS and the countries of Canada, Korea, United Kingdom
Nationwide CaliforniaColoradoIllinoisKansasMarylandMinnesotaMissouriOhioOklahomaPennsylvaniaRhode IslandTexas
Questions about this recall
Is Disposable Respiratory Products Non-rebreather Mask recalled?
Yes. Westmed recalled Disposable Respiratory Products Non-rebreather Mask on 11 Nov 2020. The recall is Class II and its status is Terminated. Recall number Z-0742-2021.
Why was it recalled?
There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection to the mask adapter resulting in a possible delay in treatment.
Which lots are affected?
Lot # 081120N42, 090220N29, 091020N88
Where was it sold?
Worldwide distribution - US Nationwide distribution including in the states of PA, OK, MO, CO, RI, IL, CA, TX, OH, MD, IL, MN, KS and the countries of Canada, Korea, United Kingdom
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.
More recalls from Westmed
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|---|---|---|---|---|---|
| Device | CLASS II | Flex Extenders, 2" OD ID recalled by Westmed | Westmed | Foreign Material | 30 states |
| Device | CLASS II | REF 0562F, Adult CO2/O2 Mask, 10'X0.50 GSL w/ Swivel Elbow, 2" recalled | Westmed | Other | Nationwide |
| Device | CLASS II | REF 3102-E, Elongated Oxygen Mask, Adult Oxygen Elongated Mask recalled | Westmed | Other | Nationwide |
| Device | CLASS II | REF 0930 Adult Elongated CO2/O2 Mask, 7' Tubing w/ Threaded Nut recalled | Westmed | Other | Nationwide |
| Device | CLASS II | REF 0562K (Adult Elongated O2/CO2 Mask - Product Usage: intended to recalled | Westmed | Other | Nationwide |
Other CPAP & Ventilators recalls
All 552| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Getinge Y Sensor Module, Servo-u, Servo-n recalled | Maquet Critical Care AB | Device Malfunction | Nationwide |
| Device | CLASS II | Biofire Respiratory Panel 1 (RP2.1) recalled by BioFire Diagnostics | BioFire Diagnostics | Other | Nationwide |
| Device | CLASS I | Astral 100/150 Resmed Astral 100/50 is a ventilator system recalled | ResMed | Packaging Defects | Nationwide |
| Device | CLASS I | Breathing circuit set, coaxial recalled by Hamilton Medical AG | Hamilton Medical AG | Device Malfunction | Nationwide |