Device recall

Z-1197-2026: Medline medical procedure convenience kits labeled as: 1) RR-GYN LAPAROSCOPY…

FDA device recall · Class II · Medline Industries, LP

Key facts

Recall number (Z-number) Z-1197-2026
Recall event 98226
Product Medline medical procedure convenience kits labeled as: 1) RR-GYN LAPAROSCOPY PACK-LF, Kit SKU DYNJ0395022O; 2) PELVISCOPY PACK-LF, Kit SKU DYNJ0415776Q; 3) DIVA PACK, Kit SKU DYNJ04811O; 4) DA VINCI PROSTATE/COLPOPEXY, Kit SKU DYNJ44864S; 5) MH ROBOTICS PACK, Kit SKU DYNJ50880L; 6) DELNOR…
Product code OHD
Recalling firm Medline Industries, LP
Recall class Class II
Status Open, Classified
FEI number 1417592

At a glance

  • None 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)