{"id":"c073dd78-3c50-4b9a-9932-c1e7f15861e8","slug":"drager-safestar-55-filter-recall-2022","kind":"recall","headline":"FDA Class I recall of 35,950 SafeStar 55 breathing system filters over possible oxygen blockage","summary":"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.","occurredAt":"2022-05-01T00:00:00.000Z","reviewStatus":"unreviewed","modelId":null,"deploymentId":null,"companyId":"552c2bf6-4bb2-4a53-992d-ff157ce2e122","aliases":[],"collisionRisk":"none","reviewNote":null,"severity":"serious","rootCauseCategory":null,"rootCauseDetail":null,"affectedUnitsCount":null,"affectedUnitsBasis":null,"remediationStatus":null,"regulatoryAction":"recall_ordered","regulatoryBody":"FDA","propertyDamageEstimateUsd":null,"damageEstimateBasis":null,"bodilyInjurySeverity":null,"fatalityCount":null,"lossCostClass":null,"sourceQualityTier":null,"oshaRecordable":null,"oshaCaseNumber":null,"rootCauseDisclosed":null,"publicDisclosureDate":null,"insuranceClaimPublic":null,"formFactor":null,"latitude":null,"longitude":null,"autonomyClass":null,"legalOutcomeClass":"unknown","createdAt":"2026-07-29T01:03:17.459Z","updatedAt":"2026-07-29T01:03:17.459Z","model":null,"deployment":null,"company":{"id":"552c2bf6-4bb2-4a53-992d-ff157ce2e122","name":"Dräger","slug":"drager","description":"Dräger is a publicly listed German medical and safety technology company headquartered in Lübeck, Germany, founded in 1889 by J. Heinrich Dräger. The family-run company develops, manufactures, and sells devices and systems in the fields of medical and safety technology — including ventilators, anaesthetic machines, gas detectors, SCBA, and breathalyzers — sold in over 190 countries. The company is listed on the Frankfurt Stock Exchange (FWB: DRW3) and generated approximately €3.37 billion in revenue in 2024 with over 16,500 employees.","status":"active","founded":1889,"hq":"Lübeck, Germany","fundingTotal":null,"type":"both","reviewStatus":"reviewed","lifecycleState":"active","supersededByCompanyId":null,"sources":[{"url":"https://www.draeger.com/","title":"Dräger","date_accessed":"2026-06-07"}],"keyFacts":[{"label":"HQ","value":"Lübeck, Germany"},{"label":"Focus","value":"Medical and safety technology"},{"label":"Technology","value":"Anesthesia, ventilation, and personal protective equipment"},{"label":"Backers","value":"Family-owned"}],"aliases":[],"collisionRisk":"low","reviewNote":null,"atsProvider":null,"atsSlug":null,"factoryLocations":null,"manufacturingCapacity":null,"orgType":null,"burnSignal":null,"litigationEvents":null,"insurancePostureDisclosed":null,"unitEconomicsDisclosed":null,"tickerSymbol":"DRW3","stockExchange":"Frankfurt Stock Exchange","secCik":null,"revenueUsd":null,"revenueBasis":null,"revenueAsOf":null,"employeeCount":16598,"employeeCountBasis":null,"employeeCountAsOf":null,"marketCapUsd":null,"marketCapAsOf":null,"marketCapSource":null,"createdAt":"2026-06-08T00:59:08.856Z","updatedAt":"2026-07-29T01:02:19.450Z"},"derived":{"status":"active"},"sources":[{"id":"e8ee135e-9da7-4700-91b9-deee089100ce","incidentId":"c073dd78-3c50-4b9a-9932-c1e7f15861e8","url":"https://www.fiercebiotech.com/medtech/fda-adds-class-i-tag-dragers-recall-36k-ventilator-breathing-system-filters","label":"Fierce Biotech","publishedAt":"2022-06-22T00:00:00.000Z","notes":null,"title":null,"sourceName":"Fierce Biotech","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-07-29T01:03:17.459Z","updatedAt":"2026-07-29T01:03:17.459Z"}],"responses":[],"statusEvents":[{"id":"b99ad660-4584-4506-9e37-15a30034d544","incidentId":"c073dd78-3c50-4b9a-9932-c1e7f15861e8","status":"active","reason":null,"source":"agent:recon","effectiveAt":"2026-07-29T01:03:18.577Z","createdAt":"2026-07-29T01:03:18.577Z"}],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/drager-safestar-55-filter-recall-2022","url":"https://registry.deploy.report/incidents/drager-safestar-55-filter-recall-2022","headline":"FDA Class I recall of 35,950 SafeStar 55 breathing system filters over possible oxygen blockage","description":"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.","identifier":"c073dd78-3c50-4b9a-9932-c1e7f15861e8","datePublished":"2022-05-01T00:00:00.000Z","articleSection":"recall","publisher":{"@id":"https://deploy.report/#organization"},"author":{"@id":"https://deploy.report/#organization"}},"framework_metadata":{"framework_schema_version":"0.1.0","verification_status":"unreviewed","maturity_stage":null,"lifecycle_state":null,"architectural_position":{"cohort":null,"sub_cohorts":[]},"within_cohort_verified_vs_claimed_pair":null,"cap_flags":[],"verification_depth":{"sources_count":1,"primary_source_types":[]}}}