Device recall

Z-0597-2012: Midmark M11 Ultra Steam Sterilizer, Distributed by: Midmark Corporation, 60…

FDA device recall · Class II · Midmark Corportation

Key facts

Recall number (Z-number) Z-0597-2012
Recall event 60456
Product Midmark M11 Ultra Steam Sterilizer, Distributed by: Midmark Corporation, 60 Vista Drive, Versailles, Ohio 45380. Sterilize reusable equipment that is heat and moisture stable.
Product code FLE
Recalling firm Midmark Corportation
Recall class Class II
Status Terminated
Termination date Jun 20, 2014
510(k) numbers K936181
FEI number 1523530

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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