Device recall

Z-0235-2025: MICR PATIE RND Model/Catalog Number: 801396. CODMAN Surgical Patties and CODMAN…

FDA device recall · Class II · Integra LifeSciences Corp.

Key facts

Recall number (Z-number) Z-0235-2025
Recall event 95432
Product MICR PATIE RND Model/Catalog Number: 801396. CODMAN Surgical Patties and CODMAN Surgical Strips are manufactured of COTTONOID Material with x-ray detectable markers. All patties have a suture string attached for ease in performing postsurgical count verification. The surgical patties and surgical…
Product code HBA
Recalling firm Integra LifeSciences Corp.
Recall class Class II
Status Open, Classified
510(k) numbers K193346
FEI number 3003418325

At a glance

  • 1–9 Linked 510(k)s
  • 10–99 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)