Device recall

Z-1009-2024: Water Filter MAJ-2318. This MAJ-2318 water filter has been designed to be used…

FDA device recall · Class II · Olympus Corporation of the Americas

Key facts

Recall number (Z-number) Z-1009-2024
Recall event 93792
Product Water Filter MAJ-2318. This MAJ-2318 water filter has been designed to be used with Olympus endoscope reprocessor for prevent contamination of the rinse water. The MAJ-2318 water filter is compatible with OER-ELITE and OER-MINI.
Product code FEB
Recalling firm Olympus Corporation of the Americas
Recall class Class II
Status Open, Classified
510(k) numbers K103264
FEI number 2429304

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)