Recall archive / FDA device enforcement
Puritan Bennett 980 Series Ventilator — FDA record Z-0966-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 25, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Puritan Bennett 980 Series Ventilator
- Reason
- The audible alarm may not sound and/or the omni-directional LED visual alarm may not display during alarm states. Delayed awareness of alarm states may lead to delayed response or a delay of treatment, potentially resulting in hypoxia, dyspnea, cardiac arrest, or death.
- Classification
- Class I
- Recalling firm
- Medtronic formerly Covidien
- Quantity
- 18,508 OUS; 18,412 US
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0966-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot/Serial Number | Product GTIN/MATNR 35B2014306 10884521171633 35B2014309 10884521171633 35B2014312 10884521171633 35B2014314 10884521171633 35B1500319 10884521201408 35B1500321 10884521201521 35B1500322 10884521201408 35B1500323 10884521201408 35B1500324 10884521201408 35B1500718 10884521201408 35B1500744 10884521201408 35B1500758 10884521201408 35B1500773 10884521201408 35B1502000 10884521212251 35B1502094 10884521201354 35B1502099 10884521201354 35B1502104 10884521201354 35B1502172 10884521201224 35B1600140 10884521201224 35B1600170 10884521201224 35B1600182 10884521201224 35B1600188 10884521201224 35B1600198 10884521201224 35B1600202 10884521201224 35B1600203 10884521201224 35B1600204 10884521201224 35B1600209 10884521201224 35B1600211 10884521201224 35B1600213 10884521212251 35B1600216 10884521201224 35B1600217 10884521201897 35B1600218 10884521201910 35B1600221 10884521201224 35B1600225 10884521201224 35B1600228 10884521201224 35B1600242 10884521201224 35B1600251 10884521201224 35B1600274 10884521201224 35B1701370 10884521201408 35B1701377 10884521201408 35B1701395 10884521201408 35B1701429 10884521201408 35B1701445 10884521201408 35B1701451 10884521201408 35B1701495 10884521201408 35B1702271 10884521201521 35B1702336 10884521201521 35B1703244 10884521201521 35B1703347 10884521201521 35B1703348 10884521201521 35B1703354 10884521201521 35B1800087 10884521201408 35B1800112 10884521201408 35B1800114 10884521201408 35B1800129 10884521201408 35B1800130 10884521201408 35B1800131 10884521201408 35B1800132 10884521201408 35B1801327 10884521201408 35B1801345 10884521201408 35B1801362 10884521201521 35B1801381 10884521201408 35B1801393 10884521201408 35B1801396 10884521201408 35B1801407 10884521201521 35B1801409 10884521201521 35B1900064 10884521201408 35B1900072 10884521201408 35B1900116 10884521201408 35B1900121 10884521201408 35B1900129 10884521201408 35B1900682 10884521201408 35B1900693 10884521201408 35B1900694 10884521201408 35B1920013 10884521201408 35B1920029 10884521201408 35B1920831 10884521201408 35B1921050 10884521201408 35B1921069 10884521201408 35B1921078 10884521201408 35B1921083 10884521201408 35B1921086 10884521201408 35B1921091 10884521201408 35B1921097 10884521201408 35B1921099 10884521201408 35B1921102 10884521201408 35B2006549 10884521201408 35B2006663 10884521201408 35B2006665 10884521201408 35B2006673 10884521201408 35B2006696 10884521201408 35B2006744 10884521201408 35B2006754 10884521201408 35B2006766 10884521201408 35B2006781 10884521201408 35B2006805 10884521201408 35B2006834 10884521201408 35B2006836 10884521201408 35B2006841 10884521201408 35B2006843 10884521201408 35B2006851 10884521201408 35B2006852 10884521201408 35B2006853 10884521201408 35B2006854 10884521201408 35B2006860 10884521201408 35B2006864 10884521201408 35B2006869 10884521201408 35B2006871 10884521201408 35B2006872 10884521201408 35B2006873 10884521201408 35B2006875 10884521201408 35B2006876 10884521201408 35B2006877 10884521201408 35B2006878 10884521201408 35B2006880 10884521201408 35B2006881 10884521201408 35B2006882 10884521201408 35B2006883 10884521201408 35B2006884 10884521201408 35B2006885 10884521201408 35B2006886 10884521201408 35B2006887 10884521201408 35B2006891 10884521201408 35B2006892 10884521201408 35B2006896 10884521201408 35B2006897 10884521201408 35B2006898 10884521201408 35B2006899 10884521201408 35B2006900 10884521201408 35B2006903 10884521201408 35B2006904 10884521201408 35B2006905 10884521201408 35B2006906 10884521201408 35B2006907 10884521201408 35B2006909 10884521201408 35B2006910 10884521201408 35B2006911 10884521201408 35B2006912 10884521201408 35B2006913 10884521201408 35B2006914 10884521201408 35B2006915 10884521201408 35B2006916 10884521201408 35B2006918 10884521201408 35B2006921 10884521201408 35B2006922 10884521201408 35B2006923 10884521201408 35B2006924 10884521201408 35B2006925 10884521201408 35B2006926 10884521201408 35B2006927 10884521201408 35B2006928 10884521201408 35B2006929 10884521201408 35B2006931 10884521201408 35B2006932 10884521201408 35B2006935 10884521201408 35B2006937 10884521201408 35B2006940 10884521201408 35B2006941 10884521201408 35B2006942 10884521201408 35B2006943 10884521201408 35B2006944 10884521201408 35B2006946 10884521201408 35B2006947 10884521201408 35B2006948 10884521201408 35B2103730 10884521201408 35B2103748 10884521201408 35B2103768 10884521201408 35B2103785 10884521201408 35B2103797 10884521201408 35B2103829 10884521201408 35B2103837 10884521201408 35B2103839 10884521201408 35B2103840 10884521201408 35B2103843 10884521201408 35B2103851 10884521201408 35B2103854 10884521201408 35B2103856 10884521201408 35B2103867 10884521201408 35B2103882 10884521201408 35B2104364 10884521201408 35B2104376 10884521201408 35B2104381 10884521201408 35B2104393 10884521201408 35B2104396 10884521201408 35B2104406 10884521201408 35B2104413 10884521201408 35B2104429 10884521201408 35B2104450 10884521201408 35B2104452 10884521201408 35B2104463 10884521201408 35B2104464 10884521201910 35B2104466 10884521201408 35B2104467 10884521201408 35B2104471 10884521201408 35B2104486 10884521201408 35B2200444 10884521201408 35B2200558 10884521201408 35B1400032 10884521201507 35B1400033 10884521201507 35B1400187 10884521201385 35B1400189 10884521201385 35B1400194 10884521201385 35B1400210 10884521201507 35B1400228 10884521201507 35B1400261 10884521201385 35B1400266 10884521201385 35B1400330 10884521201385 35B1400345 10884521201385 35B1400421 10884521201385 35B1400442 10884521201507 35B1400445 10884521201385 35B1400449 10884521201507 35B1400756 10884521201507 35B1400912 10884521201385 35B1400976 10884521201385 35B1400982 10884521201385 35B1401008 10884521201385 35B1401013 10884521201385 35B1401077 10884521201385 35B1401085 10884521201385 35B1401090 10884521201385 35B1401093 10884521201385 35B1401122 10884521201385 35B1401156 10884521201385 35B1401258 10884521201385 35B1401329 10884521201385 35B1401398 10884521201385 35B1401399 10884521201385 35B1401423 10884521201385 35B1401454 10884521201385 35B1401484 10884521201385 35B1401487 10884521201385 35B1401650 10884521201507 35B1401778 10884521201507 35B1401798 10884521201385 35B1401803 10884521201385 35B1401826 10884521201385 35B1401827 10884521201385 35B1401829 10884521201385 35B1401862 10884521201385 35B1401882 10884521201385 35B1401885 10884521201385 35B1401897 10884521201385 35B1401902 10884521201385 35B1401911 10884521201385 35B1401917 10884521201385 35B1401952 10884521201385 35B1401960 10884521201385 35B1401981 10884521201507 35B1500057 10884521201385 35B1500163 10884521201385 35B1500186 10884521201385 35B1500240 10884521201385 35B1500266 10884521201385 35B1500308 10884521201385 35B1500318 10884521201385 35B1500348 10884521201385 35B1500349 10884521201385 35B1500350 10884521201385 35B1500357 10884521201385 35B1500358 10884521201385 35B1500359 10884521201385 35B1500362 10884521201385 35B1500363 10884521201385 35B1500366 10884521201385 35B1500375 10884521201385 35B1500377 10884521201385 35B1500379 10884521201385 35B1500408 10884521201507 35B1500429 10884521201385 35B1500567 10884521201385 35B1500720 10884521201385 35B1500763 10884521201507 35B1500775 10884521201385 35B1500777 10884521201385 35B1500785 10884521201385 35B1500786 10884521201385 35B1500788 10884521201385 35B1500794 10884521201507 35B1500795 10884521201507 35B1500796 10884521201385 35B1500799 10884521201507 35B1500800 10884521201385 35B1500801 10884521201385 35B1500803 10884521201385 35B1500817 10884521201385 35B1500825 10884521201385 35B1500844 10884521201507 35B1500849 10884521201507 35B1500892 10884521201507 35B1500906 10884521201507 35B1500907 10884521201507 35B1500911 10884521201507 35B1501031 10884521171565 35B1501186 10884521201385 35B1501188 10884521172548 35B1501189 10884521171565 35B1501193 10884521171565 35B1501198 10884521171565 35B1501220 10884521171565 35B1501223 10884521171565 35B1501225 10884521171565 35B1501363 10884521171565 35B1501377 10884521171565 35B1501379 10884521201385 35B1501391 10884521171565 35B1501398 10884521171565 35B1501403 10884521201385 35B1501416 10884521171565 35B1501419 10884521171565 35B1501421 10884521171565 35B1501425 10884521171565 35B1501427 10884521171565 35B1501428 10884521172548 35B1501430 10884521171565 35B1501431 10884521171565 35B1501438 10884521171565 35B1501439 10884521171565 35B1501454 10884521171565 35B1501455 10884521201385 35B1501467 10884521171565 35B1501470 10884521171565 35B1501478 10884521201385 35B1501481 10884521171565 35B1501862 10884521171565 35B1501928 10884521171565 35B1501933 10884521171565 35B1501945 10884521171565 35B1501949 10884521171565 35B1501950 10884521171565 35B1501964 10884521171565 35B1501977 10884521171565 35B1600129 10884521171565 35B1600139 10884521171565 35B1600142 10884521174108 35B1600144 10884521174108 35B1600145 10884521174108 35B1600147 10884521174108 35B1600149 10884521174108 35B1600150 10884521174108 35B1600151 10884521174108 35B1600153 10884521174108 35B1600156 10884521174108 35B1600157 10884521174108 35B1600161 10884521174108 35B1600167 10884521171565 35B1600171 10884521171565 35B1600177 10884521171565 35B1600179 10884521171565 35B1600190 10884521171565 35B1600220 10884521171565 35B1600230 10884521171565 35B1600255 10884521171565 35B1600259 10884521174108 35B1600260 10884521174108 35B1600262 10884521171565 35B1600279 10884521171565 35B1600310 10884521171565 35B1600332 10884521171565 35B1600349 10884521171565 35B1600358 10884521171565 35B1600362 10884521171565 35B1600368 10884521171565 35B1600376 10884521171565 35B1600381 10884521171565 35B1600382 10884521171565 35B1600389 10884521171565 35B1600425 10884521174108 35B1600426 10884521174108 35B1600427 10884521174108 35B1600428 10884521174108 35B1600429 10884521174108 35B1600431 10884521174108 35B1600432 10884521174108 35B1600433 10884521174108 35B1600927 10884521174108 35B1600928 10884521174108 35B1600929 10884521174108 35B1600930 10884521174108 35B1600931 10884521174108 35B1600991 10884521174108 35B1600992 10884521174108 35B1600993 10884521174108 35B1600994 10884521174108 35B1600995 10884521174108 35B1600996 10884521174108 35B1601242 10884521174108 35B1601243 10884521174108 35B1601245 10884521174108 35B1700101 10884521201385 35B1700181 10884521201385 35B1700202 10884521201385 35B1700206 10884521201385 35B1700252 10884521201385 35B1700330 10884521201385 35B1700341 10884521201385 35B1700346 10884521201385 35B1700352 10884521201385 35B1700359 10884521201385 35B1700365 10884521201385 35B1700367 10884521201385 35B1700399 10884521201385 35B1700407 10884521201385 35B1700489 10884521201385 35B1700505 10884521201385 35B1700513 10884521201385 35B1700555 10884521201385 35B1700557 10884521201385 35B1700562 10884521201385 35B1700563 10884521201385 35B1700565 10884521201385 35B1700566 10884521201385 35B1700586 10884521201385 35B1700588 10884521201385 35B1700590 10884521201385 35B1700605 10884521201385 35B1700612 10884521201385 35B1700634 10884521201385 35B1700651 10884521201385 35B1700657 10884521201385 35B1700658 10884521201385 35B1700662 10884521201385 35B1700663 10884521201385 35B1700665 10884521201385 35B1700668 10884521201385 35B1700672 10884521201385 35B1700675 10884521201385 35B1700678 10884521201385 35B1700680 10884521201385 35B1700681 10884521201385 35B1700694 10884521201385 35B1700710 10884521201385 35B1700715 10884521201385 35B1700753 10884521201385 35B1701093 10884521201385 35B1701094 10884521201507 35B1701192 10884521201385 35B1701197 10884521201507 35B1701199 10884521201507 35B1701200 10884521201385 35B2000435 10884521201897 35B2000459 10884521201897 35B2000900 10884521201385 35B2000940 10884521201385 35B2000961 10884521201385 35B2000966 10884521201385 35B2000967 10884521201385 35B2000970 10884521201385 35B2000977 10884521201385 35B2000978 10884521201385 35B2000979 10884521201385 35B2000980 10884521201385 35B2000981 10884521201385 35B2000988 10884521201385 35B2000990 10884521201385 35B2001085 10884521201385 35B2001106 10884521201385 35B2001168 10884521201385 35B2001200 10884521201385 35B2001255 1088452120138... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide - Worldwide .Distribution
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- 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
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- May 4, 2022
- Recall initiation date
- Mar 25, 2022
- Center classification date
- Apr 24, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.