Insights for Medical Device Professionals

Here's what's happening right now: 391 new FDA recalls were issued this week, with a significant cluster in convenience kits used for dialysis maintenance. Specific examples include Medline's ADD A CATH DIALYSIS KIT (SKU ECVC8415A) and Centurion's CENTRAL LINE INSERTION TRAY (SKU DT19810), where silicone seal failures in Tego Connectors are causing occluded fluid paths and therapy delays. Health Canada added 5 more recalls, including labeling issues with Sterile Contro-Vac suction catheters. Fo

Here's what's happening right now: 391 new FDA recalls were posted this week, with 5 new Health Canada recalls. The dialysis convenience kit category shows multiple signals, including Medline's ADD A CATH DIALYSIS KIT and Centurion's CENTRAL LINE INSERTION TRAY, both citing silicone seal failures that could occlude fluid paths. Meanwhile, Edermy LLC's PIE PAK and PIE Trolley System recalls highlight 510(k) clearance issues, and orthopedic implants from Enovis face labeling errors. For your boar

Here's what's happening right now: 391 new FDA recalls were issued this week, including 5 new signals from Health Canada. Key examples include convenience kits for dialysis maintenance (e.g., Medline ADD A CATH DIALYSIS KIT, Centurion CENTRAL LINE INSERTION TRAY) due to silicone seal issues causing occluded fluid paths, and orthopedic implants like the Reverse Shoulder Prosthesis and EMPOWR 3D KNEE with incorrect labeling. Additionally, there are 26,000 new FDA Adverse Event Reports (MAUDE/MDRs)

Here's what's happening right now: 391 new FDA recalls were issued this week, with a significant cluster in convenience kits used for dialysis maintenance, including specific SKUs like Medline's ADD A CATH DIALYSIS KIT ECVC8415A and Centurion's CENTRAL LINE INSERTION TRAY DT19810. These recalls cite issues like silicone seal failures leading to occluded fluid paths, which could delay therapy or cause leaks. Additionally, there are 26,000 new FDA Adverse Event Reports (MAUDE/MDRs), with notable s

Here's what's happening right now: 391 new FDA recalls were issued this week, including 5 in convenience kits for dialysis maintenance where silicone seal failures could occlude fluid paths. Health Canada added 5 more recalls, with issues ranging from labeling errors to unauthorized devices. In total, today alone brought 26,590 new regulatory signals across FDA and Health Canada databases. For RA Managers focused on audit preparedness and QMSR compliance, this data highlights critical patterns.