Reported Oct 21, 2020 · Terminated

Levo Arm Label

Mizuho OSI

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Mizuho OSI · 30031 Ahern Ave · Union City, CA · 94587-1234

Is this the product you have?

Levo Arm Label

3 of 3 products

Products covered by this recall
Model / numberProduct as published
7887-050MIZUHO OSI
Refurbished Levo Arm Label: LEVO ARM
7887-050RMIZUHO OSI - Product Usage: used with Mizuho OSI spinal surgery tables to provide patient head support and positioning during spinal surgery.
Lot codes and dates
  • Model Number7887-050 UDI/GTIN 00842230104992
  • Affected Serial Numbers201 through 452 Model 7887-050R UDI/GTIN 00824230108440
  • Affected Serial Numbers
    • 234
    • 235
    • 248
    • 255
    • 341
    • and 448
Amount recalled
174 Arms

Where it was sold

Why it was recalled

Due to the potential for fluid ingress into the Arm which could affect the device's electrical system and lead to a failure of the locking mechanism

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 27, 2023 · Data as of Sep 19, 4:55 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.