CLASS II Device recall · Reported 12 Feb 2020 · FDA Enforcement Report
Dexcom Receiver, REF: MT22719, (Black, Pin, Blue), Rx Only recalled
Dexcom is recalling Dexcom Receiver, REF: MT22719, (Black, Pin, Blue), Rx Only, distributed nationwide in the US. The recall was initiated on 12 Jul 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0929-2020
- FDA event ID
- 84290
- Recalling firm
- Dexcom, San Diego, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Jul 2019
- FDA classified
- 31 Jan 2020
- Reported
- 12 Feb 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 12 Jul 2019 | Recall initiated by company | |
| 31 Jan 2020 | Classified by FDA | +203 days |
| 12 Feb 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
It has been reported that use of the mobile receiver with software version SW10617 rev 4.0.1.048 have reported: 1. the receiver becoming stuck on initialization screen when powering on. This will cause patients not to be able to receive glucose values or alerts; 2. Reinitialization of the receiver without user interaction. If this occurs, the receiver will either reboot and operate normally or require the user to press the Select button on the receiver in order to resume normal operation. In this situation, the user is provided an audio and vibratory alert every 5 minutes. Until the select button is pressed, patients will not receive glucose values or alerts.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Dexcom Receiver, REF: MT22719, (Black, Pin, Blue), Rx Only, containing software version SW10617 and revision 4.0.1.048 - Product Usage: A non-adjunctive invasive glucose sensor is intended to determine glucose levels, and the direction and rate of change of glucose levels in people with diabetes. The device is indicated to replace information obtained from standard blood glucose monitoring devices to make diabetes-related treatment decisions. The device also provides historical glucose information, facilitating long-term therapy adjustments.
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
It has been reported that use of the mobile receiver with software version SW10617 rev 4.0.1.048 have reported: 1. the receiver becoming stuck on initialization screen when powering on. This will cause patients not to be able to receive glucose values or alerts; 2. Reinitialization of the receiver without user interaction. If this occurs, the receiver will either reboot and operate normally or require the user to press the Select button on the receiver in order to resume normal operation. In this situation, the user is provided an audio and vibratory alert every 5 minutes. Until the select button is pressed, patients will not receive glucose values or alerts.
Which lots are affected?
All serial numbers of the G5 Mobile Receivers with software version SW10617 and software revision 4.0.1.048 Receiver Part Number/Reciver Kit Number/GUDID registered GTINS/ Receiver Kit Type: Dexcom G5 Mobile Receiver, MT22179 (BLK) Rev 013 and Rev 014 Receiver (mg/dL), Black STK-GF-001/ 10386270000238 - Starter Kit STK-RF-001/20386270000235 - Retail Starter Kit STR-GF-001/30386270000232 - Replacement Receiver Kit STK-GF-IUO/NA - Investigational Use STK-MC-001/00386270000606 - Medicare Starter Kit Dexcom G5 Mobile Receiver, MT22719 (PNK) Rev 012 and 013, Receiver (mg/dL), Pink STK-GF-PNK/ 30386270000263 - Starter Kit STK-RF-PNK/10386270000269 - Retail Starter Kit STR-GF-PNK/20386270000266 - Replacement Receiver Kit Dexcom G5 Mobile Receiver, MT22719 (BLU) Rev 012 and 013, Receiver (mg/dL), Blue STK-GF-BLU/ 30386270000270 - Starter Kit STK-RF-BLU/10386270000276 - Retail Starter Kit STR-GF-BLU/20386270000273 - Replacement Receiver Kit
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Dexcom
All 29| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | G7 Continuous Glucose Monitoring System Dexcom G7 US Retail recalled | Dexcom | Device Malfunction | CA |
| Device | CLASS II | ONE+ iOS CGM App recalled by Dexcom | Dexcom | Device Malfunction | Nationwide |
| Device | CLASS II | G7 Continuous Glucose Monitoring System Dexcom G7 CGM iOS App recalled | Dexcom | Device Malfunction | Nationwide |
| Device | CLASS II | G7 Continuous Glucose Monitoring System Dexcom G7 CGM watchOS App recalled | Dexcom | Device Malfunction | Nationwide |
| Device | CLASS I | G6 Continuous Glucose Monitoring System Dexcom G6 recalled | Dexcom | Device Malfunction | Nationwide |
Other Insulin Pumps & Glucose Monitors recalls
All 467| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | MiniMed Flex Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Labeling Errors | Nationwide |
| Device | CLASS II | Fisher Scientific Sure-Vue Urine hCG Strip recalled by Alere San Diego | Alere San Diego | Potency & Assay | Nationwide |
| Device | ANNOUNCED | StatStrip Glucose Hospital Meter System recalled by Nova BiomedicalNova Biomedical StatStrip | Nova Biomedical | Device Malfunction | |
| Device | CLASS I | StatStrip Glucose Hospital Meter System recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |
| Device | CLASS I | StatStrip Glucose and B- Ketone meter recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |