Oxysure Systems, Inc.: Medical Device Recall in 2015 - (Recall #: Z-2253-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

OxySure Model 615 disposable replacement cartridges, for portable oxygen generator.

Product Classification:

Class II

Date Initiated: June 12, 2015

Date Posted: August 5, 2015

Recall Number: Z-2253-2015

Event ID: 71524

Reason for Recall:

Flow rate of the recalled replacement cartridges does not meet the draft FDA standard of a minimum 6 LPM for a minimum of 15 minutes.

Status: Terminated

Product Quantity: 1005 units

Code Information:

lots 61-65

Distribution Pattern:

Nationwide throughout the US and Chile, Trinidad, China

Voluntary or Mandated:

Voluntary: Firm initiated