Device recall event

Recall event 81597: Tosoh Bioscience Inc

FDA device recall · Class II · Terminated

Key facts

Recall event number 81597
Recalling firm Tosoh Bioscience Inc
Recall class Class II
Status Terminated
510(k) numbers K023091, K111335, K121533, K963687, K964348, K964349, K991252, K992365

At a glance

  • 1–9 Recalled products (Z-numbers)
  • 1–9 Linked 510(k)s
  • 10–99 Recall events for this firm

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

About FDA device recall events

A recall event groups every recalled product (Z-number) from one recall action by a firm. Class I recalls involve a reasonable probability of serious harm; Class III recalls are unlikely to cause harm.

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

Browse all FDA device recall events