Philips — Class II medical device recall Z-2427-2021
Terminated recall by Philips North America LLC, reported 2021-09-15, distributed nationwide. Infant/Child defibrillator pads contain incorrect labeling. This could lead to a delay in therapy, or delivery
| Recall number | Z-2427-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America LLC, Bothell, WA, United States |
| Recall initiated | 2021-07-16 |
| Classified | 2021-09-03 |
| Reported by FDA | 2021-09-15 |
| Terminated | 2023-05-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BO, CA, CH, CL, CN, DE, DK, ES, FR, GB, HK, IE, IL, IT, JP, KR, MT, MX, NL, NO, PL, TW, UY |
| Quantity | 19,840 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00884838023758 |
| Lot numbers | Y111220-01 |
| Model numbers | M5072A |
Product
Philips, HEARTSTART, INFANT/CHILD - SMART PADS CARTRIDGE, REF: M5072A, (0-8 YEARS)< 55 lbs / 25 kg, CE 0123, NON-STERILE, Rx only, UDI: (01) 00884838023758 for use with defibrillator
Reason for recall
Infant/Child defibrillator pads contain incorrect labeling. This could lead to a delay in therapy, or delivery of lower energy than indicated for an adult patient
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-2427-2021. 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.