Device recall

Z-0165-2025: Medline brand medical procedure convenience kits, labeled as: a) PLASTIC PACK…

FDA device recall · Class II · MEDLINE INDUSTRIES, LP - Northfield

Key facts

Recall number (Z-number) Z-0165-2025
Recall event 95415
Product Medline brand medical procedure convenience kits, labeled as: a) PLASTIC PACK, REF DYNJ42735A; b) DR SELEM PACK, REF DYNJ43457; c) BREAST PK TEGH-LF, REF DYNJ46717A; d) BREAST PK TEGH-LF, REF DYNJ46717A; e) BREAST BIOPSY-LF, REF DYNJ53205B; f) BREAST BIOPSY-LF, REF DYNJ53205B; g) PLASTIC PACK, REF…
Product code FTN
Recalling firm MEDLINE INDUSTRIES, LP - Northfield
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)