RecallRadar

FDA Device recall Z-0787-2025

Medline custom medical procedure kits labeled as: 1) NEURO BASIN PACK-LF, REF DYNJ39461J

On 2025-01-08 the FDA classified a Class II recall of Medline custom medical procedure kits labeled as: 1) NEURO BASIN PACK-LF, REF DYNJ39461J 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

AgencyFDA Device
Recall numberZ-0787-2025
ClassificationClass II
Statusongoing
Initiated2024-11-21
Published2025-01-08
Last updated2026-09-13 11:57 UTC
CompanyMedline Industries Northfield
DistributionUS

Product

Medline custom medical procedure kits labeled as: 1) NEURO BASIN PACK-LF, REF DYNJ39461J; 2) NEURO BASIN KIT, REF DYNJ80200B.

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 DYNJ39461J, UDI/DI 10195327112721 (EA) 40195327112722 (CS), Lot Numbers: 22BBZ954, 22FBB472, 22GBS127, 22HBJ021…1) REF DYNJ39461J, UDI/DI 10195327112721 (EA) 40195327112722 (CS), Lot Numbers: 22BBZ954, 22FBB472, 22GBS127, 22HBJ021, 22IBN757, 22LBN387, 22LBP618, 23BBL804, 23FBL965, 23HBG346, 23IBV491, 23JBW568, 24ABJ924, 24CBG585, 24DBM211, 24FBN899, 24FBQ913, 24HBL252, 24HBV561; 2) REF DYNJ80200B, UDI/DI 10195327213978 (EA) 40195327213979 (CS), Lot Numbers: 22HBG124, 22IBJ978, 22JBL067, 22LBQ534, 23ABM279, 23BBR168, 23DBB055, 23EBV555, 23GBB476, 23IBF093, 23KBT109, 24ABA171, 24CBB183, 24DBM493, 24GBB326, 24HBB911.

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-0787-2025%22

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