Dexcom G5 Mobile Receiver Receiver Part Number: MT22719 Receiver (mg/dL), Black; MT22719-PNK, R...
FDA Device Recall #Z-1339-2016 — Class I — February 23, 2016
Recall Summary
| Recall Number | Z-1339-2016 |
| Classification | Class I — Serious risk |
| Date Initiated | February 23, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Dexcom Inc |
| Location | San Diego, CA |
| Product Type | Devices |
| Quantity | 41,925 |
Product Description
Dexcom G5 Mobile Receiver Receiver Part Number: MT22719 Receiver (mg/dL), Black; MT22719-PNK, Receiver (mg/dL), Pink; MT22719-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.
Reason for Recall
Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert.
Distribution Pattern
Worldwide Distribution-US (nationwide), Canada, Italy, Netherlands, Belgium, Norway, New Zealand, Poland, Sweden, Denmark, Slovenia, Turkey, South Africa, India, Israel, Hungary, Hong Kong, UK, Ireland, France, Finland, Spain, Portugal, Colombia, Chile, Germany, Austria, Switzerland, Kuwait, United Arab Emirates, Australia, Czech Republic, Bahrain, Lebanon, and Qatar.
Lot / Code Information
Receiver Kit Number: STK-GF-001 STK-RF-001 STR-GF-001 STK-GF-PNK STK-RF-PNK STR-GF-PNK STK-GF-BLU STK-RF-BLU STR-GF-BLU Lot Number: 5204518 5204520 5204526 5204529 5204546 5204644 5204647 5204697 5204752 5204756 5204760 5204764 5204941 5204959 5204995 5205003 5205015 5205024 5205039 5205057 5205059 5206564 5206577 5206601 5206618 5206630 5206724 5207977 5207978 5207983 5207994 5208000 5208001 5208013 5208014 5208017 5208026 5208027 5208030 5208034 5208263 5208264 5208349 5208350 5208512 5208515 5208524 5208525 5208799 5208803 5208817 5209310 5209311 5209313 5209657 5209660 5210388 5210468 5204519 5204525 5204528 5204545 5204645 5204648 5204698 5204754 5204758 5204952 5205007 5205029 5205050 5206565 5206576 5206606 5206623 5207980 5207987 5207996 5208009 5208513 5208523 5208815 5209314 5209317 5209319 5209658 5209661 5210391 5204521 5204527 5204530 5204646 5204699 5204757 5204761 5204947 5205008 5205036 5205045 5206569 5206615 5206622 5206653 5206657 5206725 5208024 5208519 5208808 5208822 5209320 5209659 5209662 5210397 5210475 5204522 5204539 5204687 5204753 5204953 5204999 5205011 5205035 5206570 5206580 5206610 5209664 5209694 5204523 5204540 5204690 5204783 5204996 5205019 5205061 5206568 5209665 5209669 5204524 5204541 5204693 5204759 5205004 5205062 5206578 5209666 5209670 5204542 5204694 5204955 5205023 5205044 5205052 5209919 5210031 5210040 5210395 5210474 5204543 5204695 5204956 5205030 5205056 5209920 5210032 5210396 5204544 5204696 5204957 5205017 5205040 5210016 5210033
Other Recalls from Dexcom Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1562-2020 | Class II | Dexcom G6 Continuous Glucose Monitoring System ... | Feb 3, 2020 |
| Z-1560-2020 | Class II | Dexcom G4 PLATINUM Continuous Glucose Monitorin... | Feb 3, 2020 |
| Z-1561-2020 | Class II | Dexcom G5 Continuous Glucose Monitoring System ... | Feb 3, 2020 |
| Z-1104-2020 | Class II | Brand Name: Dexcom G6 CGM App for iOS Software... | Nov 19, 2019 |
| Z-0929-2020 | Class II | Dexcom Receiver, REF: MT22719, (Black, Pin, Bl... | Jul 12, 2019 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.