Reported Oct 12, 2022 · Ongoing
Therapy Mask 3100 NC/SP
Philips Respironics, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Respironics, Inc. · 1001 Murry Ridge Ln · Murrysville, PA · 15668-8517
Is this the product you have?
- Therapy Mask 3100 NC/SP
- Lot codes and dates
All UnitsModel No.: 11446081144610114503811450391145040114504111450441145045114504611450471145048114504911450501145051114505211450551145056114505711450581145059114506011450611145062114506311450641145065114506611450671145068114506911450701145071114507211450731145074114545911454601145461114546211454631145464114546511454661145467114547811459161145917
- Amount recalled
- 42,954 units
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
Stop using this product now
No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Philips Respironics, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.