FDA
Smith’s Medical: CADD Infusion System Infusion Sets for use with CADD pumps
Potential lack of delivery or underdelivery and false no disposable attached (NDA) alarms.
- 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.
FDA
Multiple brand names: Various OTC medical products
Product was stored outside of labeled temperature requirements.
- Recall
FDA
Philips: Certain CPAP or Bi-Level PAP therapy masks with magnetic headgear clips or straps
potential risk of serious injury
- Safety alert
FDA
Numerous brand names: Numerous human food, animal (pet) food, medical devices, and drug products
Potential Salmonella contamination and presence of rodent activity at the distribution center
- Recall
FDA
Cook Medical: Transseptal Needle and Transseptal Needle Catheter
Complaints of rust on the products
- Recall
FDA
Philips: Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices
Potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component in these devices
- Recall
FDA
Tenacore LLC: 2001 Tenacore Replacement CareFusion Alaris 8100 bezels
Potentially weakened plastic
- Recall
FDA
Alaris: Alaris Infusion Pump
Hardware issues may cause the infusion pump to not operate as expected
- 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.