Philips OmniLab Advanced + with Heated Tube Humidifier — Class I medical device recall Z-1659-2022
Ongoing recall by Philips Respironics, Inc., reported 2022-09-14, distributed in AK, AL, AR, AZ, CA, CO, CT, DE…. Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
| Recall number | Z-1659-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Respironics, Inc., Murrysville, PA, United States |
| Recall initiated | 2022-08-26 |
| Classified | 2022-09-08 |
| Reported by FDA | 2022-09-14 |
| Distributed | 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 |
| Countries outside the US | AE, AT, AU, BD, BR, CA, CN, DE, DK, EG, FR, GB, HK, HU, IL, IN, IT, JP, MX, MY, PH, QA, RS, SG, TH, TR, TW |
| Quantity | 8 units |
| UPC / GTIN / UDI-DI | 00606959067837, 00606959068001 |
| Serial numbers | L29084645477C, L303986771E8D, L303987043BC2, L3039871356A5, L30398768A57E, L303987892EE7, L30398795FD53, L30398849CD80 |
| Model numbers | 1111124, R1111124 |
Product
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.
Reason for recall
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1659-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.