EDS Light Suspension — Class II medical device recall Z-1388-2019
Ongoing recall by Stryker Communications, reported 2019-05-29, distributed nationwide. There is a potential the joint in the suspension of the device is insufficiently assembled.
| Recall number | Z-1388-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Communications, Flower Mound, TX, United States |
| Recall initiated | 2018-11-13 |
| Classified | 2019-05-21 |
| Reported by FDA | 2019-05-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BR, CA, CL, CN, CO, EC, ES, FR, GB, IN, JP, KR, MX, NL |
| Quantity | 3,176 devices |
| Serial numbers | 100000000065406, 100000000106685 |
| Model numbers | 0682001286 |
Product
EDS Light Suspension, Central Axis, a component of the Stryker Visum LED Surgical Lighting System, with the following catalog numbers: 0682001286, EDS Light Suspension, Central Axis, 5P/FP; 0682001298, EDS Light Suspension, Central Axis, 5P; 0682001299, EDS Light Suspension, Central Axis, 5P/5P; 0682001300, EDS Light Suspension, Central Axis, FP/5P/5P; 0682001432, EDS Light Suspension, Central Axis 9P/FP; 0682001433, EDS Light Suspension, Central Axis, 9P; 0682001434, EDS Light Suspension, Central Axis, 9P/5P; and 0682001435, EDS Light Suspension, Central Axis, FP/9P/5P. Product Usage: The lighting system is intended to illuminate the operative site during surgical procedures with high intensity light.
Reason for recall
There is a potential the joint in the suspension of the device is insufficiently assembled.
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-1388-2019. 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.