Del Mar Reynolds Medical Recalls BleaseFocus Anesthesia Workstations Due to Manual Error
Del Mar Reynolds Medical is recalling BleaseFocus Anesthesia Workstations and 700/900 Series Ventilators because the user manuals describe a secondary oxygen supply failure alarm that is not actually installed in the devices.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is limited to a documentation error (manuals describing a non-existent alarm) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Del Mar Reynolds Medical, Ltd. is recalling BleaseFocus Anesthesia Workstations and 700/900 Series Ventilators. The recall involves 3 units in the United States and 3,121 units distributed outside the US. The devices were shipped with user manuals that describe a secondary O2 Supply Failure alarm. However, this alarm feature has not been incorporated into the system, and the manuals were prematurely updated for a feature that is not yet available.
The affected products are anesthesia gas machines used in medical settings. The distribution pattern includes the United States (nationwide, specifically noting North Carolina and Oklahoma) and numerous countries worldwide, including Algeria, Argentina, Bahrain, Bangladesh, Bolivia, Chile, China, Columbia, Dominican Republic, Ecuador, Egypt, Finland, Ghana, Great Britain, Guatemala, Honduras, Hong Kong, India, Indonesia, Iraq, Jamaica, Jordan, Lebanon, Libya, Malaysia, Mauritius, Mexico, Moldova, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Pakistan, Palestine, Paraguay, Peru, Philippines, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Sudan, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, Uruguay, Venezuela, and Vietnam.
Healthcare facilities and users should check their device serial numbers against the list provided in the official recall notice to determine if their equipment is affected. The primary issue is a documentation error where the manual describes a safety feature that does not exist on the device, which could lead to confusion regarding the device's alarm capabilities.
The recalled product
- Product
- BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine. In most cases, the customer ordered both a BleaseFocus anesthesia workstation and a 700/900 ventilator. In some cases, the customer may order a 700/900 stand-alone ventilator would…
- Manufacturer
- Del Mar Reynolds Medical, Ltd.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Serial numbers for three workstations in the US: focu-101917
- focu-101909
- FOCO-100077
- FOCO-100078
- FOCO-100079
- FOCO-100080
- FOCO-100081
- FOCU-000353
- FOCU-000354
- FOCU-000355
- FOCU-000356
- FOCU-000357
- FOCU-000364
- FOCU-000365
- FOCU-000405
- FOCU-000406
- FOCU-000407
- FOCU-000408
- FOCU-000409
- FOCU-000410
Distribution
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