Invacare Corporation: Medical Device Recall in 2014 - (Recall #: Z-0577-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Invacare Perfecto 2 V Oxygen Concentrator The finished device is packaged as a single unit. The service part contains a single pair of sieve beds; one pair of sieve beds is used in a single finished device. Intended to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve.

Product Classification:

Class II

Date Initiated: September 23, 2014

Date Posted: December 17, 2014

Recall Number: Z-0577-2015

Event ID: 69441

Reason for Recall:

It was determined that a defective sieve bed subassembly enabled zeolite sieve dust from the sieve beds to migrate into the valves of the manifold assembly and muffler causing a reduction in oxygen concentration.

Status: Terminated

Product Quantity: 5,963

Code Information:

The defective sieve bed subassembly manufactured from 7/31/2014 to 8/19/2014 impacts the finished device- IRC5PO2V and Service Part Number-1165099. The serial number range is as follows for the finished device: 14GF053772-14HF032124 (Sequential serial numbers)

Distribution Pattern:

Nationwide Distribution -- FL, NJ, GA, RI, PA, MI, CA, MA, IN, WA, CT, VA, NC, MO, AZ, CO, MS, MI, WI, TN, NH, IL, LA, OK, HI, KY, NE, SC, TX, IA, IN, and MS.

Voluntary or Mandated:

Voluntary: Firm initiated