Insulin Pumps & Glucose Monitors recalls

467 medical device recalls in the insulin pumps & glucose monitors category are on file with the FDA, from 2012 to 14 Oct 2026.

Total recalls467since 2012

Last 12 months50reported

Class I8719% of total

Ongoing204latest 14 Oct 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 3 3Feb 11 2 0May 7 2 0Aug 8 4 4Nov 2 0 3Feb 4 15 4May 2 5 3Aug 5 3

Severity split

Class I 87 19%Class II 354 76%Class III 25 5%Other/pending 1

Why insulin pumps & glucose monitors is recalled

Companies

Brands

Nova Biomedical StatStrip10%
CardioChek10%

By year

2026449%
20254610%
2024133%
2023266%
2022194%
2021398%
20204810%
2019225%
2018276%
201771%

Ongoing insulin pumps & glucose monitors recalls

204 active

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	MiniMed Flex Insulin Pump recalled by Medtronic MiniMed	Medtronic MiniMed	Labeling Errors	Nationwide
7 Oct 2026Device	CLASS II	Fisher Scientific Sure-Vue Urine hCG Strip recalled by Alere San Diego	Alere San Diego	Potency & Assay	Nationwide
6 Oct 2026Device	ANNOUNCED	StatStrip Glucose Hospital Meter System recalled by Nova BiomedicalNova Biomedical StatStrip	Nova Biomedical	Device Malfunction
23 Sep 2026Device	CLASS I	StatStrip Glucose Hospital Meter System recalled by Nova Biomedical	Nova Biomedical	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS I	StatStrip Glucose and B- Ketone meter recalled by Nova Biomedical	Nova Biomedical	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS I	StatStrip Glucose Hospital Meter System recalled by Nova Biomedical	Nova Biomedical	Device Malfunction	Nationwide

All insulin pumps & glucose monitors recalls, newest first

467 total

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	MiniMed Flex Insulin Pump recalled by Medtronic MiniMed	Medtronic MiniMed	Labeling Errors	Nationwide
7 Oct 2026Device	CLASS II	Fisher Scientific Sure-Vue Urine hCG Strip recalled by Alere San Diego	Alere San Diego	Potency & Assay	Nationwide
6 Oct 2026Device	ANNOUNCED	StatStrip Glucose Hospital Meter System recalled by Nova BiomedicalNova Biomedical StatStrip	Nova Biomedical	Device Malfunction
23 Sep 2026Device	CLASS I	StatStrip Glucose Hospital Meter System recalled by Nova Biomedical	Nova Biomedical	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS I	StatStrip Glucose and B- Ketone meter recalled by Nova Biomedical	Nova Biomedical	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS I	StatStrip Glucose Hospital Meter System recalled by Nova Biomedical	Nova Biomedical	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS I	StatStrip Glucose and B- Ketone meter recalled by Nova Biomedical	Nova Biomedical	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS I	StatStrip Glucose and B- Ketone meter recalled by Nova Biomedical	Nova Biomedical	Device Malfunction	Nationwide
26 Aug 2026Device	CLASS II	MiniMed Insulin Pump recalled by Medtronic MiniMed	Medtronic MiniMed	Other	CA
26 Aug 2026Device	CLASS II	MiniMed Insulin Pump recalled by Medtronic MiniMed	Medtronic MiniMed	Other	CA
26 Aug 2026Device	CLASS II	MiniMed Insulin Pump recalled by Medtronic MiniMed	Medtronic MiniMed	Other	CA
15 Jul 2026Device	CLASS II	MiniMed Insulin Pump recalled by Medtronic MiniMed	Medtronic MiniMed	Device Malfunction	CA
8 Jul 2026Device	CLASS I	Omnipod (Eros) Pod recalled by Insulet	Insulet	Packaging Defects	Nationwide
8 Jul 2026Device	CLASS I	Omnipod DASH Pod recalled by Insulet	Insulet	Packaging Defects	Nationwide
8 Jul 2026Device	CLASS I	Omnipod 5 Pods recalled by Insulet	Insulet	Packaging Defects	Nationwide
1 Jul 2026Device	CLASS II	G7 Continuous Glucose Monitoring System Dexcom G7 US Retail recalled	Dexcom	Device Malfunction	CA
17 Jun 2026Device	CLASS II	Sporetraq Mail-in Spore Testing Service, 12 Tests recalled	HF Acquisition	Device Malfunction	Nationwide
17 Jun 2026Device	CLASS II	Sporetraq Mail-in Spore Testing Service, 52 Tests recalled	HF Acquisition	Device Malfunction	Nationwide
20 May 2026Device	CLASS II	ONE+ iOS CGM App recalled by Dexcom	Dexcom	Device Malfunction	Nationwide
20 May 2026Device	CLASS II	G7 Continuous Glucose Monitoring System Dexcom G7 CGM iOS App recalled	Dexcom	Device Malfunction	Nationwide
20 May 2026Device	CLASS II	G7 Continuous Glucose Monitoring System Dexcom G7 CGM watchOS App recalled	Dexcom	Device Malfunction	Nationwide
6 May 2026Device	CLASS I	AIDBAGs are first aid kits of convenience composed recalled	North American Rescue	Device Malfunction	CA, WA
22 Apr 2026Device	CLASS I	Omnipod 5 Pods recalled by Insulet	Insulet	Packaging Defects	Nationwide
8 Apr 2026Device	CLASS II	MiniMed Insulin Pump (Mmt-1760, Mmt-1761, Mmt recalled	Medtronic MiniMed	Other	Nationwide
8 Apr 2026Device	CLASS II	MiniMed Insulin Pump (Mmt-1801, Mmt-1805, Mmt-1850, Mmt-1851) recalled	Medtronic MiniMed	Other	Nationwide
8 Apr 2026Device	CLASS II	MiniMed Insulin Pump (Mmt-1880, Mmt-1881, Mmt recalled	Medtronic MiniMed	Other	Nationwide
8 Apr 2026Device	CLASS II	MiniMed Insulin Pump (Mmt-1714, Mmt-1715, Mmt-1754, Mmt-1755) recalled	Medtronic MiniMed	Other	Nationwide
8 Apr 2026Device	CLASS II	MiniMed Insulin Pump (Mmt-1711, Mmt-1712, Mmt-1751, Mmt-1752) recalled	Medtronic MiniMed	Other	Nationwide
8 Apr 2026Device	CLASS II	MiniMed Insulin Pump (Mmt-1884, Mmt-1885, Mmt recalled	Medtronic MiniMed	Other	Nationwide
8 Apr 2026Device	CLASS II	MiniMed Insulin Pump (Mmt-551, Mmt-751) recalled by Medtronic MiniMed	Medtronic MiniMed	Other	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.