OPMI LUMERA 300, REF 6137

Recall Insight

This FDA Devices action (record #Z-0183-2024) was formally reported on November 1, 2023, with the manufacturer initiating the action on August 18, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Carl Zeiss Suzhou Co., Ltd. is listed as the recalling firm, operating out of Suzhou, N/A. Federal records indicate 8 units are affected.

The documented reason for this recall is: Surgical microscope for use in ophthalmology may be missing a screw from the suspension arm, which may cause the suspended components to fall from the suspension arm, which may injure any person under the suspended comp… Distribution data in the federal record shows the product reached: US Nationwide distribution in the states of MD, TX, CA, GA, LA.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 3 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.