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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

Newport HT70 and HT70 Plus Ventilators Recalled for Failure to Provide Air

Agency Publication Date: June 9, 2025
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Summary

Covidien is recalling 4,842 Newport HT70 and HT70 Plus ventilators, along with specific control boards and conversion kits, because internal circuit board components may fail. This defect can cause the ventilator to shut down unexpectedly during use or fail to sound an alarm if a shutdown occurs. Covidien has initiated this recall through a notification letter to healthcare facilities and distributors. If you are using an affected device, you should contact the manufacturer or your distributor immediately for a correction or replacement.

Risk

The failure of internal capacitors can lead to the device stopping the delivery of air to a patient without warning. This poses a critical risk of respiratory failure, low oxygen saturation, and hypoxia, which can be life-threatening for patients dependent on ventilator support.

What You Should Do

  1. This recall involves Newport HT70 and HT70 Plus ventilators (various REF models), HT70-2 and HT70P control boards, and HT70 conversion kits. See the Affected Products section below for the full list of affected codes.
  2. Identify if your device is affected by checking the model and serial numbers printed on the device label or packaging.
  3. Stop using the recalled device immediately and remove it from patient care areas.
  4. Contact Covidien or your authorized medical distributor to arrange for the return, replacement, or correction of your equipment.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 if you have additional questions or wish to report an adverse event.

Your Remedy Options

๐Ÿ“‹Other Action

Stop using the recalled equipment.

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Newport HT70 Ventilator
Model / REF:
HT70M-JP-NA
HT70M-CN-NA
HT70M-ES-EU
HT70M-PT-BR
HT70M-SY-EU
HT70M-WW-EU
HT70M-WW-NA
HT70-SY-EU
Serial Numbers (589):
N10HT700710132
N10HT700710135
N10HT700710136
N10HT700710159
N10HT700710161
N10HT700710162
N10HT700710163
N10HT700710164
N10HT700810194
N10HT700810199
N10HT700810202
N10HT700810204
N10HT700810205
N10HT700810206
N10HT700910223
N10HT700910227
N10HT701010279
N10HT701011015
N10HT701011016
N10HT701111044
N10HT701111048
N10HT701111049
N10HT701111050
N11HT700111137
N11HT700111139
N11HT700111141
N11HT700111142
N11HT700111143
N11HT700111144
N11HT700211145
N11HT700211155
N11HT700211160
N11HT700211161
N11HT700211163
N11HT700211164
N11HT700311168
N11HT700311169
N11HT700311170
N11HT700311183
N11HT700311184
N11HT700311185
N11HT700311186
N11HT700311188
N11HT700311189
N11HT700311191
N11HT700311192
N11HT700311193
N11HT700311195
N11HT700311196
N11HT700311197
UDI:
00839935008221
10884521542044
10884521542051
10884521542082
10884521542105
10884521542136
10884521542143
10884521544178

Units manufactured in the United States and distributed worldwide.

Product: Newport HT70Plus Ventilator
Model / REF:
HT70PM-ES-EU
HT70PM-ES-NA
HT70PM-JP-NA
HT70PM-PT-BR
HT70PM-SY-AS
DLHT70PM-WW-NA
HT70PM-SY-NA
HT70PM-SY-UK
HT70PM-WW-EU
HT70PM-WW-UK
HT70PM-SY-EU
HT70PM-WWNA
Serial Numbers (1682):
HT7P150048
HT7P150236
HT7P150381
HT7P150397
HT7P150434
HT7P150440
HT7P150446
HT7P150455
HT7P150457
HT7P150469
HT7P150470
HT7P150471
HT7P150473
HT7P150479
HT7P150522
HT7P150529
HT7P150531
HT7P150532
HT7P150537
HT7P150539
HT7P150541
HT7P150547
HT7P150548
HT7P150554
HT7P150663
HT7P160032
HT7P160033
HT7P160043
HT7P160049
HT7P160073
HT7P170003
HT7P180438
HT7P180460
N11HT700611690
N11HT701210589
N12HT720410245
N12HT720610374
N13HT720612038
N13HT721012653
N13HT721012762
N13HT721212921
N13HT721212964
N14HT720113023
N14HT720213230
N14HT720213242
N14HT720413478
N14HT720413480
N14HT720413505
N14HT720413528
N14HT721217517
UDI:
10884521542174
10884521544291
10884521544307
10884521542181
00839935009457
10884521544338
10884521542204
10884521197855
10884521208940
10884521544376
10884521542242
10884521542259
10884521542273
10884521544369
10884521542228
10884521544413
10884521542266

Includes several REF variants and DL series.

Product: HT70-2 Control Board
Model / REF:
GR105796
Serial Numbers (60):
1751DA015
1751DA069
1751DA163
1804DA010
1804DA013
1804DA020
1804DA088
1804DA131
1804DA140
1804DA177
1806DA032
1806DA037
1806DA040
1806DA041
1806DA043
1806DA044
1806DA056
1806DA083
1848DA007
2046DA028
2046DA033
2046DA050
2046DA068
2046DA071
2046DA090
2048DA038
2048DA082
2049DA006
2049DA013
2049DA056
2049DA083
2049DA086
2049DA098
2051DA011
2051DA017
2051DA020
2051DA023
2051DA032
2051DA034
2051DA035
2051DA054
2051DA058
2051DA073
2051DA090
2051DA091
2051DA094
2051DA097
2051DA107
2107DA009
2107DA059
UDI:
04987742321180

Component part used in ventilator assembly or replacement.

Product: HT70P Control Board
Model / REF:
GR105795
Serial Numbers (195):
1741DA011
1741DA028
1741DA031
1741DA035
1741DA037
1744DA217
1750DA520
1751DA066
1804DA096
1804DA185
1806DA005
1806DA027
1806DA039
1806DA049
1806DA058
1806DA084
1806DA086
1848DA002
1848DA024
1850DA013
1850DA029
1850DA042
1901DA013
1907DA003
1907DA004
1907DA012
1907DA014
1907DA019
1907DA025
1907DA029
1907DA038
1907DA041
1907DA042
1907DA043
1907DA044
1907DA045
1907DA046
1907DA047
1907DA050
1907DA052
2046DA034
2046DA045
2048DA011
2048DA013
2048DA017
2049DA005
2049DA009
2049DA016
2049DA024
2049DA027
UDI:
04987742326161

Component part used in ventilator assembly or replacement.

Product: HT70 Conversion Kit
Model / REF:
GRFSKHT70M-2
Serial Numbers (128):
1529DE080
1529DE091
1734DE044
1734DE205
1734DE220
1734DE227
1736DE020
1736DE096
1736DE191
1736DE249
1736DE394
1736DE408
1736DE490
1738DE006
1738DE022
1738DE037
1738DE059
1738DE087
1738DE371
1738DE427
1738DE477
1738DE498
1741DE139
1743DE009
1743DE059
1743DE065
1743DE069
1743DE085
1743DE089
1743DE096
1743DE097
1743DE104
1745DE012
1745DE016
1745DE026
1745DE035
1745DE037
1745DE046
1745DE047
1745DE058
1745DE074
1745DE090
1745DE109
1745DE112
1745DE115
1745DE126
1745DE145
1745DE151
1745DE192
1745DE197
UDI:
04987742372618

Upgrade kit for ventilator systems.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96774
Status: Active
Manufacturer: Covidien
Sold By: Authorized Medical Distributors; Healthcare Facilities; Hospitals
Manufactured In: United States
Units Affected: 4842
Distributed To: Alaska, Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, Wyoming

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.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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 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.