Philips OmniLab Advanced+ — Class I medical device recall Z-1657-2022
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-1657-2022 |
|---|---|
| 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 | 85 units |
| UPC / GTIN / UDI-DI | 00288710177629, 00606959028791 |
| Serial numbers | L28664716B714, L28664717A69D, L286647185E6A, L286647194FE3, L28664720F84A, L28664721E9C3, L28664722DB58, L28664723CAD1, L28664724BE6E, L28870984130F, L288709850286, L28870986301D, L288709872194, L28870988D963, L28870989C8EA, L288709904CF3, L288709915D7A, L288709926FE1, L288709937E68, L288709940AD7, L288709951B5E, L2887099629C5, L28870997384C, L28870998C0BB, L28870999D132 and 60 more |
| Model numbers | 1109581 |
Product
Philips OmniLab Advanced+, 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-1657-2022. 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.