Philips — Class II medical device recall Z-0081-2022
Ongoing recall by Philips North America LLC, reported 2021-10-20, distributed in CA, CT, FL, GA, IN, MI, MO, NJ…. Customers were not notified of previous recalls associated with various defibrillator models.
| Recall number | Z-0081-2022 |
|---|---|
| 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 | 2021-02-09 |
| Classified | 2021-10-08 |
| Reported by FDA | 2021-10-20 |
| Distributed | CA, CT, FL, GA, IN, MI, MO, NJ, NY, OH, TX, WA |
| Countries outside the US | AU, CA, CH, DE, FR, JP, NO |
| Quantity | 15 units |
| Model numbers | 0205142344, A06E-00929, A06K-02421, A06L-01678, A06L-01867, A07A-01278, A07J-05837, A07K-02685, A09H-03908, A10C-03623, A10G-05443, A11K-03264, A11K-08837, B07F-01268, M5066A, M5066A-ABD, M5067A |
Product
Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A
Reason for recall
Customers were not notified of previous recalls associated with various defibrillator models.
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-0081-2022. 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.