Device recall: MiniMed 620G Insulin Pump (O.U.S. version)
an individual recalling firm (name withheld) (Northridge, CA) initiated this device recall on 23 May 2022; FDA lists 8 product records under event 90370, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 839 device enforcement events initiated in 2022 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Individual recalling firm (name withheld), Northridge, CA. FDA names an individual as the recalling firm; this site does not publish people's names.
Reason for recall
"Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (similar to when battery cap is not attached) and a loss of power/functionality of the insulin infusion pumps."
Distribution
"U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1352-2022 | MiniMed 620G Insulin Pump (O.U.S. version) | 2,287 pumps | Class II | Ongoing | 20 Jul 2022 |
| Z-1353-2022 | MiniMed 630G Insulin Pump (U.S. and Canada Version) | 126,558 pumps | Class II | Ongoing | 20 Jul 2022 |
| Z-1354-2022 | MiniMed 640G Insulin Pump (O.U.S. Version) | 323,417 pumps | Class II | Ongoing | 20 Jul 2022 |
| Z-1355-2022 | MiniMed 670G Insulin Pump (U.S. and O.U.S. Version) | 279,251 pumps | Class II | Ongoing | 20 Jul 2022 |
| Z-1356-2022 | MiniMed 720G Insulin Pump (O.U.S. Version) | 575 pumps | Class II | Ongoing | 20 Jul 2022 |
| Z-1357-2022 | MiniMed 740G Insulin Pump (O.U.S. Version) | 40 pumps | Class II | Ongoing | 20 Jul 2022 |
| Z-1358-2022 | MiniMed 770G Insulin Pump (U.S. and O.U.S. Version) | 123,585 pumps | Class II | Ongoing | 20 Jul 2022 |
| Z-1359-2022 | MiniMed 780G Insulin Pump (O.U.S. Version) | 83,398 pumps | Class II | Ongoing | 20 Jul 2022 |
Context
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (similar to when battery cap is not attached) and a loss of power/functionality of the insulin infusion pumps."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI,…"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.