FDA Device recall Z-0777-2025

Medline custom medical procedure kits labeled as: 1) CATH LAB PACK-LF, REF DYNJ0382559M

FDA Device
Class II
ongoing
Published 2025-01-08

On 2025-01-08 the FDA classified a Class II recall of Medline custom medical procedure kits labeled as: 1) CATH LAB PACK-LF, REF DYNJ0382559M by Medline Industries Northfield, citing custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0777-2025
Classification	Class II
Status	ongoing
Initiated	2024-11-21
Published	2025-01-08
Last updated	2026-09-13 11:57 UTC
Company	Medline Industries Northfield
Distribution	US

Product

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.

Reason

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

Identifiers

code_info	1) REF DYNJ0382559M, UDI/DI 10889942063994 (EA) 10889942063995 (CS), Lot Numbers: 19TBC792; 2) REF DYNJ56001B, UDI… 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.

code_info

1) REF DYNJ0382559M, UDI/DI 10889942063994 (EA) 10889942063995 (CS), Lot Numbers: 19TBC792; 2) REF DYNJ56001B, UDI…

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.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0777-2025%22

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