FDA
BMC: Luna G3 APAP (Model LG3600)
The firmware version, G3-2.00.76 installed on the Luna G3 APAP (Model LG3600) devices contained a firmware defect
- Recall
Medical device recalls
A device recall may call for a repair, a software update or new instructions. Identify your exact device, then read what FDA and the manufacturer say to do next.
- Indexed notices
- 64
- Primary sources
- FDA
What this category covers
Glucose monitors, CPAP devices, Test kits, Implants. Home health equipment, test kits and implants, including FDA recalls and early safety alerts.
Check with the official agency or read the product identification guide. Source coverage explains which notices are indexed and when each source was imported.
Recalls & safety alerts
64 indexed notices. Always compare with the current official notice.
FDA
Medline, Teleflex: Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits
Due to heated wire connector (pigtail) at the Neptune humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localized thermal damage
- Recall
FDA
BD: Intraosseous Vascular Access System Needle Sets
Due to Reports of Difficulty Removing the Obturator
- Recall
FDA
Dexcom G7: Continuous Glucose Monitoring System
Sensors identified as scrap were diverted and sold by third-party
- Safety alert
FDA
Omnipod: Device intended for the subcutaneous delivery of insulin into a patient
Manufacturing issue that could result in under delivery of insulin
- Safety alert
FDA
TRUE METRIX: Blood Glucose Monitoring Systems
As currently written, the Owner’s Booklets/System Instructions for Use fails to emphasize that users must seek medical attention immediately if they receive an E-5 error code and are experiencing symptoms of high glucose.
- Safety alert
FDA
Aligned Medical Angio Pack: Angio Packs (AMS6908E and AMS6908F)
Risk of the syringe rotating adapter unwinding during use, which may result in a loose connection and/or full disconnection between the syringes and manifold, potentially causing biohazard exposure, blood loss, infection, or air embolism.
- Recall
FDA
Omnipod: Alternate controller enabled insulin infusion pump
Pods may have a small tear in the internal tubing that delivers insulin. This may leak inside the Pod instead of being fully infused into the body as intended.
- Safety alert
How to check medical devices
- Manufacturer & model
- Device name, model or catalog number from its label or packaging.
- Serial, lot or UDI
- The identifiers specified in the notice; retain packaging where possible.
- Version & care records
- Software version when relevant, or an implant card and clinician’s records.
1. Identify the whole system
Check the device and any affected accessory or consumable. A monitor, sensor, mask or test strip can have a different manufacturer and identifier.
2. Read the kind of action
FDA lists serious recalls and early alerts. A correction may update a device or its instructions without removing it. An early alert can precede FDA’s final recall classification.
3. Plan the next step with your provider
Follow the notice’s instructions and contact your care team or device supplier when treatment is involved. A recall does not automatically mean an implant should be removed or a prescribed device switched off.
Official checking resources
- FDA device recalls & early alerts — Serious device recalls, early alerts and updates.
- FDA device recall database — Search the broader database by device, company or recall information.
Data sources & coverage
Official sources may have newer notices or a broader history. See all sources and coverage.
Medical devices recall questions
Does a recall always mean returning the device?
No. Some recalls involve corrections such as revised instructions or software updates. Read the official notice for the action that applies to your device.
What is an FDA early alert?
It is a communication about a potentially serious device problem while FDA is still collecting or reviewing information. It is distinct from a confirmed recall and may be updated.
How do I check an implanted device?
Use your implant card or ask your clinician for the manufacturer and device identifiers. Discuss the notice with your care team; a recall alone does not establish a need for removal.