RecallRadar

FDA Device recall Z-2226-2024

Sterile surgical convenience kit: Medline Neuro IR Pack, Pack #DYNJ56073C, containing a Pure Pouch with component Medline Reorder #DYNJ0404…

On 2024-07-10 the FDA classified a Class II recall of Sterile surgical convenience kit: Medline Neuro IR Pack, Pack #DYNJ56073C, containing a Pure Pouch with component Medline Reorder #DYNJ0404… by Medline Industries Northfield, citing surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2226-2024
ClassificationClass II
Statusongoing
Initiated2024-03-14
Published2024-07-10
Last updated2026-09-13 11:57 UTC
CompanyMedline Industries Northfield
DistributionUS

Product

Sterile surgical convenience kit: Medline Neuro IR Pack, Pack #DYNJ56073C, containing a Pure Pouch with component Medline Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile.

Reason

Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.

Identifiers

code_infoPack #DYNJ56073C - lot numbers 23IDA509, exp. 5/31/2026, and 23DDC159, exp. 11/30/2025, UDI-DI each-10193489441833, UDI-DI case-40193489441834.

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-2226-2024%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.