Recall archive / FDA device enforcement
Puritan Bennett 980 Series Ventilator, 980X3ENDIUU — FDA record Z-0352-2022
Reported terminated
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 Nov 4, 2021. 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, 980X3ENDIUU
- Reason
- Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- Classification
- Class I
- Recalling firm
- Covidien Llc
- Quantity
- 278 total
- Agency-reported status
- Terminated
- Source record identifier
- Z-0352-2022
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 | GTIN/UDI - 10884521172524 Serial Numbers: 35B1700308 35B1700311 35B1700361 35B1700363 35B1700364 35B1700366 35B1700368 35B1700369 35B1700370 35B1700371 35B1700373 35B1700375 35B1700376 35B1700377 35B1700378 35B1700379 35B1700380 35B1700382 35B1700383 35B1700385 35B1700386 35B1700389 35B1700390 35B1700391 35B1700392 35B1700394 35B1700395 35B1700398 35B1700400 35B1700401 35B1700402 35B1700404 35B1700410 35B1700414 35B1700415 35B1700417 35B1700421 35B1700422 35B1700423 35B1700424 35B1700433 35B1700441 35B1700444 35B1700446 35B1700448 35B1700450 35B1700454 35B1700455 35B1700463 35B1700466 35B1700491 35B1700497 35B1700498 35B1700500 35B1700506 35B1700515 35B1700521 35B1700523 35B1700524 35B1700528 35B1700532 35B1700535 35B1700550 35B1700556 35B1700571 35B1700607 35B1700620 35B1700666 35B1700989 35B1701004 35B1701015 35B1701417 35B1701419 35B1702698 35B1702873 35B1703371 35B1703383 35B1703421 35B1800480 35B1800511 35B1800522 35B1800531 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US Nationwide.
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
- Dec 15, 2021
- Recall initiation date
- Nov 4, 2021
- Center classification date
- Dec 9, 2021
- Termination date
- Jul 9, 2024
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.