FDA
Ovation: Ovation iX system
A material weakness adjacent to the polymer fill channel may become compromised during pressurization with liquid polymer.
- Safety alert
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.
- Recall
FDA
LIFEPAK 15: LIFEPAK 15 monitor/defibrillators
Failure to deliver a defibrillation shock after the “Shock” button on the keypad is pressed
- Safety alert
FDA
Metrix, Baxter: Empty IV flexible containers (bag)
Potential for leaking of the IV bag at the chamber divider rod
- Recall
FDA
BIOCELL®: BIOCELL® textured breast implants and tissue expanders
Due to uncommon incidence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)
- Recall
FDA
Alaris: Alaris Pump Module Model 8100 and Certain Alaris Pump Infusion Sets
Weakening of the plastic can lead to damage or separation of the bezel posts which can cause issues with infusion, or unintended delivery of medication when pump module is not in running status
- Recall
- Safety alert
Read the product identification guide
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.