Respironics Ventilator Battery Recall: Unqualified Design Verification Risk
Respironics recalls specific ventilator batteries due to unqualified design verification. Affected units may pose safety risks if used without proper certification.
Use caution until it’s fixed
Due to unqualified "design verification" batteries being shipped to customers.
Contact the company
What happened, in plain English
Respironics is recalling certain ventilator batteries that were shipped with unqualified design verification. This could lead to safety issues if the batteries are used without proper certification. Read more at govinfonow.com/recall/63463-respironics-ventilator-battery-recall-unqualified-design-verification-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/63463-respironics-ventilator-battery-recall-unqualified-design-verification-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1137-2021
Cite this page
“Respironics Ventilator Battery Recall: Unqualified Design Verification Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63463-respironics-ventilator-battery-recall-unqualified-design-verification-risk. Based on FDA recall #Z-1137-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1137-2021%22&limit=1).
Why it’s dangerous
The batteries were shipped without proper design verification, meaning they may not meet safety standards. This could lead to potential safety issues if the batteries are used without proper certification.
Who’s affected
Patients using ventilators with the specific battery model and lot code are affected. Healthcare providers and caregivers who use these ventilators are most at risk.
How to tell if you have this one
Check for the battery model number 1076374 and lot code M94663-P1 on the battery. The ventilator is intended for use with Respironics-recommended accessories.
- Brand
Respironics- Category
Medical device
What to do — step by step
Check Battery Details
Identify the battery model number 1076374 and lot code M94663-P1 on the battery.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 11 states.
FDA distribution: “U.S. Nationwide distribution including in the states of FL, GA, IA, IA, IL. IL, MN, MO, NC, ND, OH, TX, TX and UT.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, Georgia, Illinois, Iowa, Minnesota, Missouri, North Carolina, North Dakota, Ohio, Texas, Utah.
Recall timeline
FDA published this recall 56 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-1137-2021 (January 6, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1137-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.