Data Foundry

Medical device recalls 2022

Philips BiPAP V30 Auto — Class I medical device recall Z-1656-2022

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 numberZ-1656-2022
Product typeMedical device
ClassificationClass I
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmPhilips Respironics, Inc., Murrysville, PA, United States
Recall initiated2022-08-26
Classified2022-09-08
Reported by FDA2022-09-14
DistributedAK, 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 USAE, 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
Quantity295 units
UPC / GTIN / UDI-DI00286647041624, 00290843582706, 00290845650052, 00290846086003, 00290952827507, 00304508625520, 00305539991301, 00606959039377, 00606959067936
Serial numbersN286646884854, N28664691CC4D, N28664692FED6, N28664693EF5F, N286646949BE0, N286646958A69, N28664696B8F2, N28664697A97B, N28664698518C, N286646994005, N286647005000, N286647014189, N286647027312, N28664703629B, N286647041624, N2866470507AD, N2866470724BF, N28664708DC48, N288710497A15, N28871061C5ED, N28871062F776, N28871063E6FF, N28888622D550, N28888623C4D9, N28888624B066 and 270 more
Model numbers1111155, 1111178

Product

Philips BiPAP V30 Auto, 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-1656-2022. 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.