RecallRadar

FDA Device recall Z-2040-2019

Monoject Standard Hypodermic Needle, 18 G x 1-1/2" Item code: 8881200078

On 2019-07-31 the FDA classified a Class II recall of Monoject Standard Hypodermic Needle, 18 G x 1-1/2" Item code: 8881200078 by Cardinal Health 200, citing manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2040-2019
ClassificationClass II
Statuscompleted
Initiated2019-04-30
Published2019-07-31
Last updated2026-09-13 11:55 UTC
CompanyCardinal Health 200
DistributionUS

Product

Monoject Standard Hypodermic Needle, 18 G x 1-1/2" Item code: 8881200078

Reason

Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product

Identifiers

code_infoLot Number: 907007

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: completed.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2040-2019%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.