Device recall event

Recall event 65572: Ortho-Clinical Diagnostics

FDA device recall · Class II · Terminated

Key facts

Recall event number 65572
Recalling firm Ortho-Clinical Diagnostics
Recall class Class II
Status Terminated
510(k) numbers K001133, K001679, K001885, K012593, K023875, K023876, K030626, K042006, K063591, K072440, K081543, K120609 and 27 more

At a glance

  • 10–99 Recalled products (Z-numbers)
  • 10–99 Linked 510(k)s
  • 100–999 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