Abiomed recalls 10 Impella CP Sets with SmartAssist due to low purge pressure defects that may interrupt mechanical circulatory support; affected units distributed to seven US states and three international countries.
Stryker's Triathlon Universal Baseplate Size 3 and 4 (lots UZD9IB and TYX7OB) are subject to a Class II recall due to mispackaged units distributed nationwide across multiple states.
ConMed AirSeal 12mm Access Port and Obturator (catalog iASB12-100) is subject to a Class II recall affecting 1,261 packs distributed nationwide and internationally due to potential overpressure alerts.
Philips recalls Model 708032 and 708034 MultiDiagnost Eleva systems due to hand switch button defects potentially causing imaging loss or unintended radiation exposure and contrast injection.
AMD Medicom Inc. recalls 7,838,200 Ritmed neurological sponges in multiple sizes due to potential elevated endotoxin levels that may cause neurovascular adverse events, fever, inflammation, or other temporary health complications during neurological…
Merit Medical Systems recalls 5,004 Splashwire Hydrophilic Guide Wire units nationwide and internationally due to unsealed pouch portions that may cause temporary health problems.
GE Medical Systems recalls Giraffe OmniBed Field Replaceable Units (models 6600-1056-400, 6600-1461-500, and 2 others) due to potential canopy soffit fastener disengagement that could fall into patient compartments during transport.
Medtronic recalls 589 units of O-arm O2 Imaging System (Model BI70002000) worldwide due to detector panel firmware anomaly that may cause temporary image artifacts.
Inspire Medical Systems recalls 10 Inspire Stimulation Lead units (Model 4063) distributed nationwide and in Hong Kong due to incorrectly labeled expiration dates that may exceed validated shelf life and cause material degradation requiring revision…
STAAR Surgical AG issued a Class II recall of 543 units of STAAR ICL Calculation Software Version 8.00 due to software coding errors in toric implant orientation calculations affecting nationwide US distribution.
Tell Bizmoon what your business does and we'll cut the Federal Register down to what actually matters.
Every rule is broken into specific to-dos with calendar dates.
We tell you which parts of your business each rule actually touches.
After healthcare come the capital-heavy sectors: trade, transportation, energy, and finance. If you operate in one of them, the volume of change is relentless.
No legal jargon. Read the impact in two sentences.
Email + dashboard pings the moment something changes.
