Device recall

Z-0561-03: Boston Medical Products Otocell Ear Wick 15 mm, sterile Ref: EW-0915

FDA device recall · Class II · Boston Medical Products, Inc.

Key facts

Recall number (Z-number) Z-0561-03
Recall event 25435
Product Boston Medical Products Otocell Ear Wick 15 mm, sterile Ref: EW-0915
Recalling firm Boston Medical Products, Inc.
Recall class Class II
Status Terminated
Termination date Oct 5, 2007
510(k) numbers K972581
FEI number 1219795

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event

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)