Datex-Ohmeda, Inc.
Complete recall history across all FDA and CPSC categories — 16 total recalls
Datex-Ohmeda, 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 (16)
FDA medical device enforcement actions by Datex-Ohmeda, Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Jul 12, 2024 | Aespire View. This anesthesia gas machine is intended to provide general inha... | Potential issue that may arise if the limb of a patient breathing circuit is ... | Class I |
| Jul 12, 2024 | Auxiliary Common Gas Outlet (ACGO) conversion/install kits sold under product... | Potential issue that may arise if the limb of a patient breathing circuit is ... | Class I |
| Jul 12, 2024 | Aespire 7900. This anesthesia gas machine is intended to provide general inha... | Potential issue that may arise if the limb of a patient breathing circuit is ... | Class I |
| Jul 12, 2024 | Amingo. OUS only. | Potential issue that may arise if the limb of a patient breathing circuit is ... | Class I |
| Jul 12, 2024 | Avance. This anesthesia gas machine is intended to provide general inhalation... | Potential issue that may arise if the limb of a patient breathing circuit is ... | Class I |
| Jul 12, 2024 | Aespire 7100, 7100 (Variant), and Aespire 7100 S/5 Protiva configurations. Th... | Potential issue that may arise if the limb of a patient breathing circuit is ... | Class I |
| Jul 12, 2024 | Aisys. This anesthesia gas machine is intended to provide general inhalation ... | Potential issue that may arise if the limb of a patient breathing circuit is ... | Class I |
| Jul 12, 2024 | Aisys CS2. This anesthesia gas machine is intended to provide general inhalat... | Potential issue that may arise if the limb of a patient breathing circuit is ... | Class I |
| Jul 12, 2024 | Avance CS2 and Avance CS2 Pro. These anesthesia gas machines are intended to ... | Potential issue that may arise if the limb of a patient breathing circuit is ... | Class I |
| Jul 12, 2024 | Aespire 100. This anesthesia gas machine is intended to provide general inhal... | Potential issue that may arise if the limb of a patient breathing circuit is ... | Class I |
| Jul 12, 2024 | Aisys CS2 with Et Control. This anesthesia gas machine is intended to provide... | Potential issue that may arise if the limb of a patient breathing circuit is ... | Class I |
| Dec 29, 2023 | EVair air compressor, model numbers: M1230849 and M1230847 | GE HealthCare has become aware of elevated levels of formaldehyde when the EV... | Class I |
| Dec 29, 2023 | EvAir CPRSR Kit Upgrade: a) DISS/CEE 7/7 230V 50/60 HZ, Model Number M1230... | GE HealthCare has become aware of elevated levels of formaldehyde when the EV... | Class I |
| Dec 29, 2023 | EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002 | GE HealthCare has become aware of elevated levels of formaldehyde when the EV... | Class I |
| Jun 28, 2018 | The Neonatal Flow Sensor Cable used on devices CARESCAPE R860, ENGSTROM CARES... | The Neonatal Flow Sensor Cable may be missing the connector housing exposing ... | Class II |
| Dec 8, 2017 | CARESCAPE R860 ventilators with software version 10SP05 Product Usage: Th... | Potential for the display processor to experience an unexpected failure. | Class II |
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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