Lower riskMedical device recall · FDA · Published September 18, 2018
Puritan Bennett 980 Ventilators: USB Drive Issues May Affect Ventilator Display
Puritan Bennett recalls 980 ventilators with serial numbers 35B1300001-35B1801541 for potential GUI display errors from USB drive performance. Owners should check serial numbers and contact the company.
Software Update: External USB Drive performance and its impact on Graphic User Interface (GUI) functionality and labeling of the scalar waveform displayed on GUI during ventilation
Take action
Contact the company
📍Recalling firmCOVIDIEN LLC15 Hampshire St · Mansfield, MA 02048-1113
✎ GovInfoNow plain-language explainer
Puritan Bennett is recalling its 980 ventilator series due to software issues with USB drives that could cause incorrect display of ventilator waveforms. This affects hospital use and patients needing respiratory support. The issue does not pose an immediate safety risk but requires attention to prevent misinterpretation of patient data. Read more at govinfonow.com/recall/69849-puritan-bennett-980-ventilators-usb-drive-issues-may-affect-ventilator.
“Puritan Bennett 980 Ventilators: USB Drive Issues May Affect Ventilator Display.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69849-puritan-bennett-980-ventilators-usb-drive-issues-may-affect-ventilator. Based on FDA recall #Z-0497-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0497-2019%22&limit=1).
The FDA announced on September 18, 2018, that Covidien LLC is recalling Puritan Bennett 980 ventilator series devices due to software issues affecting the graphic user interface. The agency issued recall number Z-0497-2019 for the voluntary Class I recall.
Serial Numbers: 35B1300001 through 35B1300051; 35B1400003 through 35B1402216; 35B1500001 through 35B1502227; 35B1600001 through 35B1601408; 35B1700001 through 35B1702519; 35B1800001 through 35B1801541; 35B1400001; 35B1601182, 35B1601183, 35B1601193, 35B1601197, 35B1601242, 35B1601243, 35B1601245, 35B1702479, 35B1601001, 35B1601089
Units affected: 9,593
The hazard
The recall addresses software performance issues with external USB drives that impact the Graphic User Interface (GUI) functionality and labeling of the scalar waveform displayed during ventilation. The FDA classified this as a Class I hazard.
Context
GovInfoNow's records show Covidien LLC has 52 other recalls on record since August 7, 2017. Recent brand recalls include a May 13, 2026 recall of the EndoFLIP System for catheters incorrectly flagged as expired and April 23, 2026 recalls of the Mon-a-Therm Stethoscope and Shiley Disposable Decannulation Plug for unapproved sensors and incorrect labeling. Other recent recalls of similar products include the Philips Respironics Trilogy EV300 Ventilator Software Issue (March 2, 2026), the Philips Respironics Trilogy Evo Ventilator Software Issue (March 2, 2026), and the Philips Respironics Trilogy Evo O2 Ventilator Software Issue (March 2, 2026).
How to tell if you have this one
Check the serial numbers on your Puritan Bennett 980 ventilator, which range from 35B1300001 to 35B1801541. The product is used in hospitals for patients needing respiratory support from neonates to adults.
Brand
Puritan Bennett
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Serial Numbers
Identify your ventilator's serial number to confirm if it falls within the range 35B1300001 to 35B1801541.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide Distribution - US Nationwide Foreign: Canada Argentina Chile Japan Hong Kong Taiwan Uruguay Austria Austria Azerbaijan Belgium Bosnia And Herzegovina Bulgaria Croatia Czech Republic France Germany Greece Hungary Ireland Israel…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.4 years after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0497-2019 (September 18, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0497-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.