MEDLINE INDUSTRIES, LP - Northfield: Medical Device Recall in 2025 - (Recall #: Z-1364-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Proxima Drape labeled as PACK,BASIC,SIRUS,V,5/CS; PACK,BASIC IV,SIRUS,5/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,UNIVERSAL II,SIRUS,7/CS; PACK,LAPAROTOMY,NO GOWN,10/CS; PACK,CYSTOSCOPY,PK VI,14/CS; PACK,CYSTOSCOPY,PK VI,14/CS; PACK,OB III,GRADUATED UNDERBUTTOCK,6/CS; PACK,LAVH,AURORA,4/CS. Sterile surgical drape.

Product Classification:

Class II

Date Initiated: February 13, 2025

Date Posted: March 26, 2025

Recall Number: Z-1364-2025

Event ID: 96401

Reason for Recall:

Potential breach in pouch packaging which could lead to loss of sterility.

Status: Ongoing

Product Quantity: 1,490 units

Code Information:

Item No. DYNJP1020S, DYNJP1025S, DYNJP1040, DYNJP1055S, DYNJP3000, DYNJP5050, DYNJP6060S, DYNJP9120A; UDI (case): 40080196308126, 40080196308133, 40080196722892, 40080196308195, 40080196722946, 40080196753391, 40884389110295, 40080196915416; UDI (each): 10080196308125, 10080196308132, 10080196722891, 10080196308194, 10080196722945, 10080196753390, 10884389110294, 10080196915415; Lot No. 31124090044H, 31124090028F, 31124080024F, 31124080061F, 31124090029F, 31124090089F, 31124100077F, 31124090030H, 31124090054F, 31124070070F, 31124080063F, 45024090166, 31124100007F.

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated