Z-1658-2022 Class I Ongoing
FDA device recall Z-1658-2022 was initiated by Philips Respironics, Inc. on Aug 26, 2022 and is designated Class I. Reason for recall: Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. The recall status is ongoing. Affected quantity: 34 units ***updated January 2024 *** additional 3 units.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 14, 2022
- Initiation Date
- Aug 26, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 34 units ***updated January 2024 *** additional 3 units
Product Description
Reason for Recall
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.
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1658-2022
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026