Device recall

Z-3031-2026: healthmark ProChek-II, Model Number PT-313, PT-201-12

FDA device recall · Class II · Healthmark Industries Co., Inc.

Key facts

Recall number (Z-number) Z-3031-2026
Recall event 99537
Product healthmark ProChek-II, Model Number PT-313, PT-201-12
Product code SDC
Recalling firm Healthmark Industries Co., Inc.
Recall class Class II
Status Open, Classified
FEI number 1000160387

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 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)