Data Foundry

Medical device recalls 2022

DreamWisp Nasal Mask with Over the Nose Cushion — Class I medical device recall Z-1782-2022

Ongoing recall by Philips Respironics, Inc., reported 2022-10-12, distributed nationwide. No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices

Recall numberZ-1782-2022
Product typeMedical device
ClassificationClass I
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmPhilips Respironics, Inc., Murrysville, PA, United States
Recall initiated2022-09-06
Classified2022-09-30
Reported by FDA2022-10-12
DistributedNationwide (US)
Countries outside the USAR, AT, AU, BD, BE, BG, BH, BM, BO, BR, CA, CH, CL, CN, CO, CR, CW, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GH, GT, HK, HR, HU, ID, IE, IL, IN, IS, IT, JM, JO, JP, KE, KR, KW, KY, LB, LT, MA, MT, MX, MY, NL, NO, NP, NZ, OM, PH, PK, PL, PT, PY, QA, RO, RS, SA, SE, SG, SI, SK, SV, TH, TR, TW, UA, UY, ZA
Quantity930,813 units
Model numbers1137916, 1137916RTL, 1137918, 1137921, 1137922, 1137923, 1137924, 1137925, 1137926, 1137927, 1137928, 1137929, 1137930, 1137931, 1137932, 1137933, 1137934, 1137935, 1137936, 1137937, 1137938, 1137939, 1137940, 1137941, 1137942 and 47 more

Product

DreamWisp Nasal Mask with Over the Nose Cushion

Reason for recall

No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.

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-1782-2022. 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.