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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices/Home Healthcare

ResMed Ltd.: ResMed Non-Invasive Masks Recalled for Potential Magnetic Interference

Agency Publication Date: December 21, 2023
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Summary

ResMed Ltd. has issued a significant recall affecting approximately 28.7 million masks used for channeling airflow to patients, including various AirFit and AirTouch models. These masks contain magnets that may interfere with certain medical implants, such as pacemakers, or metallic objects in the body. The recall was initiated to update user warnings and contraindications regarding a safe distance of at least 6 inches between the mask magnets and any medical devices or implants that could be affected.

Risk

The magnets in these masks can create magnetic interference with active medical implants or ferromagnetic metallic objects. This interference could cause medical devices to malfunction or implants to shift position, potentially leading to serious injury or death.

What You Should Do

  1. Check if your mask is one of the affected models: AirFit N10, AirFit F20, AirTouch F20, AirFit N20, AirTouch N20, AirFit F30, or AirFit F30i.
  2. Verify your mask against the specific User Guide versions and GTIN/UDI-DI numbers provided, such as AirFit N10 User Guide 628153/version 2020-07 or earlier.
  3. Maintain a safe distance of at least 6 inches (150 mm) between the mask magnets and any active medical implants or metallic implants/objects containing ferromagnetic material.
  4. If you or anyone in close physical contact with you has an implant that may be affected (such as a pacemaker, defibrillator, or neurostimulator), consult your healthcare provider to determine if you should switch to a non-magnetic mask.
  5. Contact ResMed customer support or your healthcare provider for further instructions and information regarding the updated safety warnings at 1-800-424-0737 or visit www.resmed.com.
  6. Contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for additional questions.

Your Remedy Options

๐Ÿ“‹Other Action

Updated warnings and safety instructions

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: AirFit N10 Nasal Masks and User Guide
Model / REF:
User Guide 628153/version 2020-07 (and prior)
UPC Codes:
619498632008
619498632893
619498632060
619498632077
619498632299
619498632015
619498632084
619498632022
619498632237
619498632190
619498632213
619498632220
619498632183
619498632206
619498632268
619498632244
619498632114
619498632251
619498632091
619498632107
619498632152
619498632121
619498632138
619498632275
619498632169
619498632145
619498632176
Lot Numbers:
All mask lots used with specified User Guide
Product: AirFit F20 Full Face Mask and User Guide
Model / REF:
User Guide 638220/version 2020-02
638238/version 2020-12
638221/version 2020-01 (and prior)
UPC Codes (60):
619498634019
619498634484
619498634460
619498634002
619498634453
619498634033
619498634569
619498634477
619498634026
619498634040
619498634491
619498634507
619498634521
619498634538
619498640065
619498640072
619498634064
619498640096
619498634316
619498640058
619498634118
619498640119
619498634071
619498634248
619498634217
619498634224
619498634330
619498634200
619498634347
619498634323
619498634309
619498634255
619498634231
619498634279
619498634286
619498634262
619498634057
619498634293
619498634095
619498634088
619498634361
619498634378
619498634354
619498640218
619498640201
619498640225
619498634132
619498634187
619498634163
619498634101
Lot Numbers:
All mask lots used with specified User Guides
Product: AirTouch F20 Full Face Mask and User Guide
Model / REF:
User Guide 638220/version 2020-02 (and prior)
UPC Codes:
619498630028
619498630189
619498630172
619498630141
619498630059
619498630097
619498630080
619498630011
619498630004
619498630042
619498630066
619498630134
619498630073
619498630035
619498630158
619498630165
619498630523
619498630530
619498630516
619498630363
619498630356
619498630349
619498630387
619498630370
Lot Numbers:
All mask lots used with specified User Guide
Product: AirFit N20 Nasal Mask and User Guide
Model / REF:
User Guide 638218/version 2020-02
638243/version 2020-06 (and prior)
UPC Codes:
619498635016
619498635054
619498635061
619498635351
619498635047
619498635030
619498635078
619498635382
619498635023
619498635344
619498635009
619498635399
619498635115
619498635122
619498635375
619498635214
619498635221
619498635252
619498635245
619498635313
619498635337
619498635207
619498635320
619498635238
619498635092
619498635108
619498635306
619498635290
619498635184
619498635146
619498635160
619498635139
619498635177
619498635153
Lot Numbers:
All mask lots used with specified User Guides
Product: AirTouch N20 Nasal Mask and User Guide
Model / REF:
User Guide 638218/version 2020-02 (and prior)
UPC Codes:
619498639069
619498639045
619498639052
619498639021
619498639038
619498639007
619498639076
619498639014
619498639540
619498639205
619498639229
619498639113
619498639090
619498639120
619498639212
Lot Numbers:
All mask lots used with specified User Guide
Product: AirFit F30 Full Face Mask and User Guide
Model / REF:
User Guide 638234/version 2020-07 (and prior)
UPC Codes:
619498641048
619498641000
619498641017
619498641406
619498641055
619498641116
619498641277
619498641109
619498641154
619498641260
619498641147
Lot Numbers:
All mask lots used with specified User Guide
Product: AirFit F30i Full Face Mask and User Guide
Model / REF:
User Guide 638225/version 2020-02 (and prior)
UPC Codes:
619498633326
619498633067
619498633012
619498633340
619498633302
619498633333
619498633050
619498633319
619498633005
619498633135
619498633128
619498633364
619498633388
619498633371
619498633401
619498633395
619498633104
619498633142
619498633111
619498633081
619498633074
Lot Numbers:
All mask lots used with specified User Guide

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93499
Status: Active
Manufacturer: ResMed Ltd.
Sold By: Authorized ResMed dealers; Medical supply companies
Manufactured In: Australia
Units Affected: 7 products (199,796; 11,885,039; 3,816,138; 7,724,968; 424,309; 2,660,776; 2,037,323)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท FDA Press Release ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.