MEDLINE INDUSTRIES, LP - Northfield: Medical Device Recall in 2025 - (Recall #: Z-0777-2025)

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:

Medline custom medical procedure kits labeled as: 1) CATH LAB PACK-LF, REF DYNJ0382559M; 2) CRANI, REF DYNJ56001B; 3) GENDER AFFIRMING SURGERY, REF DYNJ66252; 4) GENDER AFFIRMING SURGERY, REF DYNJ66252A; 5) MAJOR NEURO PACK-LF, REF DYNJ0578916X.

Product Classification:

Class II

Date Initiated: November 21, 2024

Date Posted: January 8, 2025

Recall Number: Z-0777-2025

Event ID: 95852

Reason for Recall:

Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.

Status: Ongoing

Product Quantity: 1236 units

Code Information:

1) REF DYNJ0382559M, UDI/DI 10889942063994 (EA) 10889942063995 (CS), Lot Numbers: 19TBC792; 2) REF DYNJ56001B, UDI/DI 10889942798278 (EA) 40889942798279 (CS), Lot Numbers: 19BDC737, 19FDA310, 19FDB230, 19JDA441; 3) REF DYNJ66252, UDI/DI 10193489324785 (EA) 40193489324786 (CS), Lot numbers: 20DBK065, 20FBN251, 20HBL176, 20HBM692, 21CBP776; 4) REF DYNJ66252A, UDI/DI 10193489887853 (EA) 40193489887854 (CS), Lot numbers: 21IBN151, 21KBO915, 21LBJ105, 21VBB714; 5) REF DYNJ0578916X, UDI/DI 10193489288384 (EA) 40193489288385 (CS), Lot numbers: 22OBL262,20CKA219, 20CKA875, 20EKB076, 20GKA543, 20GKB272, 20IKB497, 20JKB716, 21AKA500, 21BKA195, 21FMD808, 21HMD657, 21IMB172, 21JMH627, 21KMH877, 21LMC161, 22AMA533, 22DMC612, 22DMI233, 22GMB685, 22IMA041, 23AMD730, 23DMA094, 23FMF542, 23IME618, 24AMA230.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated