Device recall

Z-2170-2023: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the…

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

Key facts

Recall number (Z-number) Z-2170-2023
Recall event 92466
Product Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BREAST BIOPSY KIT, Model Number DYNDA1224B; b) U/S CORE BIOPSY KIT, Model Number DYNDH1121C; c) BIOPSY PACK, Model Number DYNDH1124; d) REVAMP BIOPSY TRAY, Model Number DYNDH1147A; e) BREAST BIOPSY TRAY, Model…
Product code OFG
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)