Covidien recalls specific Puritan Bennett 980 Series ventilators due to a capacitor assembly error that could make them inoperable during use. Affected units have unique serial numbers and GTIN/UDI codes.
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
Covidien is recalling certain Puritan Bennett 980 Series ventilators because a manufacturing error may cause the device to stop working during use. This could impact patients relying on these life-support devices.
A capacitor assembly error in the ventilator could cause it to become inoperable during use. This means the device might stop working when needed, potentially affecting patient care.
Healthcare facilities using the specific ventilator models with serial numbers listed in the recall are most at risk. Patients using these ventilators may experience temporary inoperability.
Check if your ventilator has the serial numbers: 35B1700548, 35B1700551, 35B1700560, 35B1700572, 35B1700577, 35B1700603, 35B1700606, or 35B1700615. The GTIN/UDI code is 10884521201545.
Verify if your ventilator has the serial numbers listed in the recall: 35B1700548, 35B1700551, 35B1700560, 35B1700572, 35B1700577, 35B1700603, 35B1700606, or 35B1700615.
A manufacturing assembly error caused a capacitor to be assembled incorrectly, which may make the ventilator inoperable during use.
Check if your ventilator has the specific serial numbers listed in the recall. If it does, contact Covidien for further instructions.
The recall record does not mention a remedy or fix for this issue.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-0344-2022 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-0344-2022 from Covidien. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.