Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0183-2024 — OPMI LUMERA 300, REF 6137

U.S. FDA — Device Enforcement · China · 2023-08-18 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0183-2024
Date of alert
2023-08-18
Country / jurisdiction
China
Risk level
Class II
Risk type
recall
Brand
Carl Zeiss Suzhou Co., Ltd.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
06909262061375
Reported risk: 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 components.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.