Berchtold Chromophare F528 Surgical Lights — Class II medical device recall Z-2539-2019
Ongoing recall by Stryker Communications, reported 2019-09-18, distributed nationwide. The back cover of the light head was insufficiently assembled and could potentially fall off the light.
| Recall number | Z-2539-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Communications, Flower Mound, TX, United States |
| Recall initiated | 2019-03-22 |
| Classified | 2019-09-12 |
| Reported by FDA | 2019-09-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, CA, CH, CN, CO, DE, DK, ES, FR, GB, HK, ID, IN, IT, JP, KR, KW, LT, MX, NL, PH, PL, RU, SA, SE, TW, UY, VN, ZA |
| Quantity | 946 lights |
Product
Berchtold Chromophare F528 Surgical Lights. Product Usage: The medical lights are for usage in hospital treatment rooms. They provide localized lighting focused on the patient s body for detecting and treating disease, injury, and disability. The surgical lights may only be used in rooms used for medical purposes that have been equipped in accordance with VDE 0100-710 or IEC 60364-7-10 in accordance with the regulations.
Reason for recall
The back cover of the light head was insufficiently assembled and could potentially fall off the light.
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-2539-2019. 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.