Stryker — Class II medical device recall Z-1428-2021
Terminated recall by Stryker Corporation, reported 2021-04-21, distributed nationwide. Their is a potential that Video Processor/Illuminators may exhibit flickering, loss of image or unintended reb
| Recall number | Z-1428-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Corporation, San Jose, CA, United States |
| Recall initiated | 2021-02-26 |
| Classified | 2021-04-15 |
| Reported by FDA | 2021-04-21 |
| Terminated | 2023-12-15 |
| Distributed | Nationwide (US) |
| Quantity | 125 units |
| UPC / GTIN / UDI-DI | 00858701006049 |
| Model numbers | PC9001 |
Product
Stryker, REF PC9001, PINPOINT Video Processor/Illuminator, Rx Only CE 0197, MD Medical Device, UDI: (01) 00858701006049 - Product Usage: used with both the SPY-PHI and PINPOINT systems, the intended use for both imaging systems are being documented here.
Reason for recall
Their is a potential that Video Processor/Illuminators may exhibit flickering, loss of image or unintended reboots.
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-1428-2021. 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.