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Incident · Recall

FDA Class I recall of 35,950 SafeStar 55 breathing system filters over possible oxygen blockage

Dräger recalled 35,950 SafeStar 55 breathing system filters distributed in the US between August 18 and October 12, 2021, after discovering that some defective filters may have been distributed rather than destroyed due to an error in the manual inspection process. Partially obstructed filters could prevent oxygen from flowing properly to a patient, potentially leading to hypoxia, organ damage, or death.

Dräger received one complaint and one injury report, with no deaths reported. The FDA designated this as a Class I recall.

Occurred 2022-05-01 · Dräger · Investigated by FDA

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Track FDA Class I recall of 35,950 SafeStar 55 breathing system filters over possible oxygen blockage

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Sources (1)

  1. Fierce Biotech · https://www.fiercebiotech.com/medtech/fda-adds-class-i-tag-dragers-recall-36k-ventilator-breathing-system-filters · 2022-06-22

Status history

  • Active · 2026-07-29 · agent:recon

Common questions

What happened in FDA Class I recall of 35,950 SafeStar 55 breathing system filters over possible oxygen blockage?
Dräger recalled 35,950 SafeStar 55 breathing system filters distributed in the US between August 18 and October 12, 2021, after discovering that some defective filters may have been distributed rather than destroyed due to an error in the manual inspection process. Partially obstructed filters could prevent oxygen from flowing properly to a patient, potentially leading to hypoxia, organ damage, or death. Dräger received one complaint and one injury report, with no deaths reported. The FDA designated this as a Class I recall.
When did this incident occur?
The incident is recorded as occurring on May 1, 2022 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
Who was involved in FDA Class I recall of 35,950 SafeStar 55 breathing system filters over possible oxygen blockage?
The incident is recorded as involving Dräger on the DEPLOY registry. No specific robot model is linked to this incident in the registry.
Has anyone responded to FDA Class I recall of 35,950 SafeStar 55 breathing system filters over possible oxygen blockage?
No responses to this incident are recorded on the DEPLOY registry. Operators, manufacturers, or affected parties can submit responses to the editorial team; absence is not a guarantee no response was issued.
What is the current status of FDA Class I recall of 35,950 SafeStar 55 breathing system filters over possible oxygen blockage?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.
Methodology: Unreviewed · 1 source (no primary) · last reviewed 2026-07-29

Verification posture

Unreviewed

Low confidence

Review state

Stable

Last reviewed 2026-07-29

Sources by quality tier

1
unclassified
Unclassified source

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Methodology surface for FDA Class I recall of 35,950 SafeStar 55 breathing system filters over possible oxygen blockage.

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Canonical ID c073dd78-3c50-4b9a-9932-c1e7f15861e8