Device recall event

Recall event 80317: SPS Sterilization, Inc

FDA device recall · Class II · Terminated

Key facts

Recall event number 80317
Recalling firm SPS Sterilization, Inc
Recall class Class II
Status Terminated
510(k) numbers K042065, K042910, K073559, K120072, K123370, K140208, K152842

At a glance

  • 10–99 Recalled products (Z-numbers)
  • 1–9 Linked 510(k)s
  • 1–9 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