MEDLINE INDUSTRIES, LP - Northfield: Medical Device Recall in 2024 - (Recall #: Z-0175-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.
Product Description:

Medline brand medical procedure convenience kits, labeled as: a) LITHOTOMY PACK, REF DYNJ24362C; b) MAJOR GYNE LAPAROSCOPY SHSC, REF DYNJ46774B; c) GYN ANCILARY PACK, REF DYNJ84509; d) GYN LITHOTOMY MINOR, REF DYNJ907707

Product Classification:

Class II

Date Initiated: September 4, 2024
Date Posted: October 30, 2024
Recall Number: Z-0175-2025
Event ID: 95415
Reason for Recall:

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Status: Ongoing
Product Quantity: 197 units
Code Information:

a) REF DYNJ24362C, UDI/DI 40889942830054 (each), 10889942830053 (case), Lot Numbers: 24ABG207; b) REF DYNJ46774B, UDI/DI 40889942582748 (each), 10889942582747 (case), Lot Numbers: 23LBN531; c) REF DYNJ84509, UDI/DI 40195327372881 (each), 10195327372880 (case), Lot Numbers: 23LBL712; d) REF DYNJ907707, UDI/DI 40193489848978 (each), 10193489848977 (case), Lot Numbers: 24ABR224

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of Canada, Panama.

Voluntary or Mandated:

Voluntary: Firm initiated