Draeger, Inc.
Complete recall history across all FDA and CPSC categories — 19 total recalls
Draeger, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (19)
FDA medical device enforcement actions by Draeger, Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| May 7, 2026 | Atlan A350. Model Number: 8211500. anesthesia workstation | The Atlan anesthesia workstation either indicated a failure of the piston ven... | Class I |
| May 7, 2026 | Atlan A350XL. Model Number: 8621600. anesthesia workstation | The Atlan anesthesia workstation either indicated a failure of the piston ven... | Class I |
| Nov 24, 2025 | Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer. | A certain component of affected devices was not delivered within specificatio... | Class I |
| Nov 24, 2025 | Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer. | A certain component of affected devices was not delivered within specificatio... | Class I |
| Nov 10, 2025 | ErgoStar CM 55, Model/Catalog Number: MP01855, Airway connector for c... | Multiple complaints were reported in which cracks formed in the hose of speci... | Class I |
| Nov 10, 2025 | ErgoStar CM 40 Model/Catalog Number: MP01840 Airway connector for condu... | Multiple complaints were reported in which cracks formed in the hose of speci... | Class I |
| Nov 10, 2025 | ErgoStar CM 45, Model/Catalog Number: MP01845, Airway connector for co... | Multiple complaints were reported in which cracks formed in the hose of speci... | Class I |
| Nov 10, 2025 | ErgoStar CM 60, Model/Catalog Number: MP01860, Airway connector for c... | Multiple complaints were reported in which cracks formed in the hose of speci... | Class I |
| Sep 9, 2025 | Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 ... | The device either indicated a failure of the piston ventilator before use or ... | Class I |
| Sep 9, 2025 | Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 S... | The device either indicated a failure of the piston ventilator before use or ... | Class I |
| Jun 16, 2025 | HME TwinStar HEPA Plus Filter. Bidirectionally breathing system filter. | Reports of slow increase of CO2-curve when gas sample is taken from the gas s... | Class I |
| Jun 16, 2025 | SafeStar 60A Plus Filter. Bidirectionally breathing system filter. | Reports of slow increase of CO2-curve when gas sample is taken from the gas s... | Class I |
| Jun 16, 2025 | SafeStar 55 Plus Filter. Bidirectionally breathing system filter. | Reports of slow increase of CO2-curve when gas sample is taken from the gas s... | Class I |
| Jun 16, 2025 | SafeStar 90 Plus Filter. Bidirectionally breathing system filter. | Reports of slow increase of CO2-curve when gas sample is taken from the gas s... | Class I |
| Mar 12, 2025 | Brand Name: ID Circuit Product Name: ID Circuit Flex 220 Model/Catalog Numb... | The potential for cracks forming in the breathing circuit hose. | Class I |
| Mar 12, 2025 | Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex... | The potential for cracks forming in the breathing circuit hose. | Class I |
| Mar 12, 2025 | Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex... | The potential for cracks forming in the breathing circuit hose. | Class I |
| Mar 12, 2025 | Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex... | The potential for cracks forming in the breathing circuit hose. | Class I |
| Mar 12, 2025 | Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex... | The potential for cracks forming in the breathing circuit hose. | Class I |
| Mar 12, 2025 | Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex... | The potential for cracks forming in the breathing circuit hose. | Class I |
| Mar 12, 2025 | Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: ... | The potential for cracks forming in the breathing circuit hose. | Class I |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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