Device recall

Z-2286-2023: STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a…

FDA device recall · Class II · Scican Ltd.

Key facts

Recall number (Z-number) Z-2286-2023
Recall event 92682
Product STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. Model: G4 622303
Product code FLE
Recalling firm Scican Ltd.
Recall class Class II
Status Open, Classified
510(k) numbers K192910
FEI number 1000273801

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

Browse all FDA device recalls (products)