Philips — Class II medical device recall Z-0882-2022
Ongoing recall by Philips North America LLC, reported 2022-04-13, distributed nationwide. There is a potential for AED pads to experience gel separation from the foam/tin backing when peeled from the
| Recall number | Z-0882-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America LLC, Bothell, WA, United States |
| Recall initiated | 2022-02-04 |
| Classified | 2022-04-06 |
| Reported by FDA | 2022-04-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, AW, BD, BE, BG, BO, CA, CH, CL, CN, CO, CR, CW, CY, CZ, DE, DK, DO, DZ, EC, EE, ES, FI, FR, GB, GR, GT, HK, HR, HU, ID, IE, IL, IN, IT, JP, KE, KR, LT, LU, MT, MX, MY, NG, NL, NO, NZ, PA, PE, PH, PL, PT, PY, QA, SA, SE, SG, SV, TT, TW, UY, VN, ZA |
| Quantity | 331,712 units |
| Model numbers | M5072A |
Product
Philips, REF M5072A, INFANT/CHILD - SMART PADS CARTRIDGE (0-8 YEARS). Smart PADS CARTRIDGE , (0-8 YEARS) <55 lbs/25 kg, CE 0123, NON-STERILE, Rx only FOR USE WITH HEARSTART DEFIBRILLATORS
Reason for recall
There is a potential for AED pads to experience gel separation from the foam/tin backing when peeled from the plastic liner. The gel may fold onto itself resulting in reduced surface area or gel on the pad, or it may separate almost completely leaving only a small amount of gel on the pad.
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-0882-2022. 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.