Device recall

Z-0038-2025: 3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

FDA device recall · Class II · 3M Company - Health Care Business

Key facts

Recall number (Z-number) Z-0038-2025
Recall event 95273
Product 3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
Product code FRO
Recalling firm 3M Company - Health Care Business
Recall class Class II
Status Open, Classified
510(k) numbers K063458, K080620, K123679, K153410, K171908, K200835
FEI number 2110898

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 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)