Philips Respironics, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1659-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Philips OmniLab Advanced + with Heated Tube Humidifier, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.

Product Classification:

Class I

Date Initiated: August 26, 2022

Date Posted: September 14, 2022

Recall Number: Z-1659-2022

Event ID: 90695

Reason for Recall:

Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.

Status: Ongoing

Product Quantity: 8 units

Code Information:

UDI-DI: 606959067837, 606959068001; Model No.: 1111124, R1111124; Serial No. L29084645477C, L303986771E8D, L303987043BC2, L3039871356A5, L30398768A57E, L303987892EE7, L30398795FD53, L30398849CD80

Distribution Pattern:

Domestic: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, TN, TX, VA, VT, WA, WI, WV, & WY. Foreign: Australia, Austria, Bangladesh, Brazil, Canada, China, Denmark, Egypt, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Myanmar, Philippines, Qatar, Serbia, Singapore, Taiwan, Thailand, Turkey, UAE, & UK.

Voluntary or Mandated:

Voluntary: Firm initiated