Data Foundry

Medical device recalls 2024

Garbin EVO — Class I medical device recall Z-1500-2024

Ongoing recall by Philips Respironics, Inc., reported 2024-04-24, distributed nationwide. Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has suffici

Recall numberZ-1500-2024
Product typeMedical device
ClassificationClass I
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmPhilips Respironics, Inc., Murrysville, PA, United States
Recall initiated2024-03-19
Classified2024-04-17
Reported by FDA2024-04-24
DistributedNationwide (US)
Quantity1,233 units
UPC / GTIN / UDI-DI00260842606611, 00319211191897, 00319406436253, 00319490111043, 00328071983689, 00328082065572, 00328096909886, 00606959057432, 00800075769709, 00800137070798, 00800162643639
Serial numbersH239876824C6F, H23987734972D, H247406117747, H247407147A36, H25230916F2B1, H252309795E96, H25233095B739, H252331214F69, H2523313375A3, H25233139DAF9, H252331466F06, H25235209546F, H25235233D15D, H2523527084A6, H252353009372, H252353108AAA, H25235326C5F4, H252354246AE3, H25235432160D, H2523547360E4, H252356192ED6, H25235633B23C, H25235651C5FE, H25235661EF96, H252356907DD7 and 475 more
Model numbersLD2110X23B

Product

Garbin EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)

Reason for recall

Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.

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-1500-2024. 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.