FDA Device recall Z-1388-2019
EDS Light Suspension, Central Axis, a component of the Stryker Visum LED Surgical Lighting System, with the following catalog numbers: 0682…
- FDA Device
- Class II
- ongoing
- Published 2019-05-29
On 2019-05-29 the FDA classified a Class II recall of EDS Light Suspension, Central Axis, a component of the Stryker Visum LED Surgical Lighting System, with the following catalog numbers: 0682… by Stryker Communications, citing there is a potential the joint in the suspension of the device is insufficiently assembled.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1388-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2018-11-13 |
| Published | 2019-05-29 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Stryker Communications |
| Distribution | US |
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
There is a potential the joint in the suspension of the device is insufficiently assembled.
Identifiers
| code_info | Serial numbers 100000000065406 to 100000000106685. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1388-2019%22
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