The Recall Desk
HighFDA (Devices)·Z-1117-2022·Announced 2022-05-25

Portable Oxygen Concentrator Recalled for Lack of FDA Clearance

Caire, Inc. is recalling two CAIRE FreeStyle Comfort portable oxygen concentrators because they were not cleared by the FDA for U.S. distribution. The affected devices were distributed to Puerto Rico.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device that was not cleared for U.S. distribution. While no illnesses or injuries have been reported, the recall involves a critical respiratory device lacking required FDA clearance, representing a potential risk to patients.

Plain-English summary

Caire, Inc. is recalling two CAIRE FreeStyle Comfort portable oxygen concentrators, model number AS200-3, identified by serial numbers CBB5221200337 and CBB5221200287.

The recalled devices were not cleared by the FDA for U.S. distribution.

The affected units were distributed to Puerto Rico. Consumers who received one of these devices should contact Caire, Inc. for instructions regarding the recalled device.

The recalled product

Product
CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
Manufacturer
Caire, Inc.
Category
Medical Device — Oxygen Concentrator
Hazard
  • regulatory-non-compliance

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 (1)

  • Serial numbers CBB5221200337 and CBB5221200287.

Distribution

Distribution scope not specified by the agency.

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