FDA
BD Alaris: BD Alaris Pump Module model 8100 used with a subset of compatible pump infusion sets
Pump performance variations compared to the performance described in the user manual could impact infusion delivery
- 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
Tandem Diabetes Care, Inc.: t:slim X2 insulin pumps
Potential speaker-related issue that can trigger an error resulting in a discontinuation of insulin delivery
- Safety alert
FDA
Max Mobility/Permobil: Speed Control Dial Component
Due to potential safety and performance concerns
- Recall
FDA
Alaris™ and BD Alaris™: Pump Modules
May have been serviced with previously recalled bezel kit assemblies
- Recall
FDA
Newport™: Newport™ HT70 and HT70 Plus ventilators and certain related service parts
Device & Drug Safety - Potential Defect
- Recall
- Recall
FDA
Max Mobility/Permobil: Speed Control Dial Component
Expanded recall due to potential safety and performance concerns
- Recall
FDA
enVista Aspire: enVista Aspire™, enVista Envy™ and Certain enVista® Monofocal Intraocular Lenses
Increased frequency of reports of toxic anterior segment syndrome
- Recall
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.