FDA Device recall Z-0778-2025

Medline custom medical procedure kits labeled as: 1) OPEN HEART CDS-LF, REFCDS840451M

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) OPEN HEART CDS-LF, REFCDS840451M 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-0778-2025
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) OPEN HEART CDS-LF, REFCDS840451M; 2) NEURO PACK, REFDYNJ41516M; 3) RFD- AAA PACK, REFDYNJ54242B; 4) OPEN HEART A&B, REFDYNJ901203C; 5) OPEN HEART A&B, REFDYNJ901203D; 6) ACDF-LF, REFDYNJ906681B; 7) ACDF-LF, REFDYNJ906681C.

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 CDS840451M, UDI/DI 10195327417574 (EA) 40195327417575 (CS), Lot Numbers: 24BLA736; 2) REF DYNJ41516M, UDI/D… 1) REF CDS840451M, UDI/DI 10195327417574 (EA) 40195327417575 (CS), Lot Numbers: 24BLA736; 2) REF DYNJ41516M, UDI/DI 10193489202564 (EA) 40193489202565 (CS), Lot Numbers: 19JKB417, 19LKA454, 20AKB109, 20DKB147, 20FKB171; 3) REF DYNJ54242B, UDI/DI 10195327167097 (EA) 40195327167098 (CS), Lot Numbers: 23GBO400; 4) REF DYNJ901203C, UDI/DI 10889942572526 (EA) 40889942572527 (CS), Lot numbers: 19BKA270, 19CKC053, 19EKD526, 19FKC478, 19HKA796, 19KKA783, 19LKB868, 20BKA558, 20FKA993, 20IKA397, 20LKA831, 21BKA583, 21DKA592, 21GMB734; 5) REF DYNJ901203D, UDI/DI 10193489947526 (EA) 40193489947527 (CS), Lot Numbers: 21GME287, 21JMH613, 22AMB438, 22CMD928, 22CMF425, 22EMF242, 22FMG716, 22GMH022, 22IMD195, 23AMB881, 23DME044, 23DME245, 23EMI884, 23HMH269, 23HMI447, 23LMB223, 24AMB281, 24CMI324, 24EMC691, 24EMI830; 6) REF DYNJ906681B, UDI/DI 10195327106881 (EA) 40195327106882 (CS), Lot Numbers: 22FBC663, 22OBM278; 7) REF DYNJ906681C, UDI/DI 10195327173838 (EA) 40195327173839

code_info

1) REF CDS840451M, UDI/DI 10195327417574 (EA) 40195327417575 (CS), Lot Numbers: 24BLA736; 2) REF DYNJ41516M, UDI/D…

1) REF CDS840451M, UDI/DI 10195327417574 (EA) 40195327417575 (CS), Lot Numbers: 24BLA736; 2) REF DYNJ41516M, UDI/DI 10193489202564 (EA) 40193489202565 (CS), Lot Numbers: 19JKB417, 19LKA454, 20AKB109, 20DKB147, 20FKB171; 3) REF DYNJ54242B, UDI/DI 10195327167097 (EA) 40195327167098 (CS), Lot Numbers: 23GBO400; 4) REF DYNJ901203C, UDI/DI 10889942572526 (EA) 40889942572527 (CS), Lot numbers: 19BKA270, 19CKC053, 19EKD526, 19FKC478, 19HKA796, 19KKA783, 19LKB868, 20BKA558, 20FKA993, 20IKA397, 20LKA831, 21BKA583, 21DKA592, 21GMB734; 5) REF DYNJ901203D, UDI/DI 10193489947526 (EA) 40193489947527 (CS), Lot Numbers: 21GME287, 21JMH613, 22AMB438, 22CMD928, 22CMF425, 22EMF242, 22FMG716, 22GMH022, 22IMD195, 23AMB881, 23DME044, 23DME245, 23EMI884, 23HMH269, 23HMI447, 23LMB223, 24AMB281, 24CMI324, 24EMC691, 24EMI830; 6) REF DYNJ906681B, UDI/DI 10195327106881 (EA) 40195327106882 (CS), Lot Numbers: 22FBC663, 22OBM278; 7) REF DYNJ906681C, UDI/DI 10195327173838 (EA) 40195327173839

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-0778-2025%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.