The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0248-2020·Announced 2019-11-06

Caire SAROS Oxygen System Model 3000 Recalled for Power Issue

Caire, Inc. is recalling 10 SAROS Oxygen System Model 3000 units due to an electronics control issue that prevents the device from powering on with battery power only.

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, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.

Plain-English summary

Caire, Inc. is recalling 10 units of the SAROS Oxygen System Model 3000. The recall is due to an electronics control issue that causes the unit to not power on when using battery power only.

The affected units were distributed in the United States and Chile. The specific serial numbers for the recalled units are CBB0817510005, CBB0817510003, CBB0817510004, CBB0817480515, CBB0817460330, CBB0818281053, CBB0817510001, CBB0817510002, CBB0818330784, and CBB0818281052.

Consumers should check their serial numbers against the list provided. If the device is affected, they should contact Caire, Inc. for instructions on how to proceed.

The recalled product

Product
SAROS Oxygen System Model 3000
Manufacturer
Caire, Inc.
Affected units
10

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 (10)

  • Serial Numbers: CBB0817510005
  • CBB0817510003
  • CBB0817510004
  • CBB0817480515
  • CBB0817460330
  • CBB0818281053
  • CBB0817510001
  • CBB0817510002
  • CBB0818330784
  • CBB0818281052

Distribution

Distribution scope not specified by the agency.

Similar recalls