RecallRadar

FDA Device recall Z-0111-2018

Medtronic MiniMed(TM) Pro-set(TM) (MMT-280, 281)

On 2017-11-29 the FDA classified a Class II recall of Medtronic MiniMed(TM) Pro-set(TM) (MMT-280, 281) by Medtronic, citing medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0111-2018
ClassificationClass II
Statusongoing
Initiated2017-09-10
Published2017-11-29
Last updated2026-09-13 11:54 UTC
CompanyMedtronic
Distributionn/a

Product

Medtronic MiniMed(TM) Pro-set(TM) (MMT-280, 281)

Reason

Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.

Identifiers

code_infoLot Numbers: 6211649, 6207537

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0111-2018%22

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