Philips HeartStart Infant/Child SMART Pads Cartridge — Class II medical device recall Z-2549-2019
Terminated recall by Philips North America LLC, reported 2019-10-02, distributed in AK, AL, AR, AZ, CA, CO, CT, DE…. The recall is being initiated due to incorrect age range labeling (8+ yrs) on the foil packaging for infant/ch
| Recall number | Z-2549-2019 |
|---|---|
| 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 | 2018-08-08 |
| Classified | 2019-09-20 |
| Reported by FDA | 2019-10-02 |
| Terminated | 2021-04-29 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY |
| Countries outside the US | AE, AR, AT, AU, AW, BE, BO, CA, CH, CL, CN, CO, CR, CY, DE, DK, DO, EG, ES, FR, GB, GR, HK, ID, IE, IL, IN, IT, JP, KR, MT, MX, MY, NL, NO, NZ, PA, PE, PH, PL, PY, SE, SG, SV, TT, TW, UY, VN, ZA |
| Quantity | 181,894 infant |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00884838023758 |
| Lot numbers | Y011118-07, Y070115-04 |
| Model numbers | M5072A |
Product
Philips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:00884838023758
Reason for recall
The recall is being initiated due to incorrect age range labeling (8+ yrs) on the foil packaging for infant/child pad cartridges. The infant/child pad cartridge is designed for use with the defibrillator An Infant/Child pad cartridge should not be used on an adult because it delivers lower energy (50 J vs 150 J) than the Adult pads cartridge and may therefore not be effective on an adult.
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-2549-2019. 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.