Data Foundry

Medical device recalls 2026

Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system… — Class I medical device recall Z-2735-2026

Ongoing recall by ResMed Ltd., reported 2026-08-05, distributed nationwide. Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger ch

Recall numberZ-2735-2026
Product typeMedical device
ClassificationClass I
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmResMed Ltd., Bella Vista, N/A, Australia
Recall initiated2026-06-25
Classified2026-07-28
Reported by FDA2026-08-05
DistributedNationwide (US)
Countries outside the USAE, AR, AT, AU, BD, BE, BG, BH, BR, CA, CH, CL, CO, CY, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GR, HK, HN, HR, HU, ID, IL, IN, IR, IS, IT, JO, JP, KE, KR, KW, LB, LK, LT, LV, MA, MT, MX, MY, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PT, QA, RO, SA, SE, SG, SI, TH, TN, TR, TW, UY, VN, ZA
Quantity168,069 devices
Reason classespackaging
UPC / GTIN / UDI-DI00619498003259, 00619498270033
Serial numbers22241440282, 22241890149, 22241978070

Product

Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilatory support for patients weighing more than 11lb (5kg) who require mechanical ventilation.

Reason for recall

Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of ventilation therapy.

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-2735-2026. 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.