FDA regulations
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- GE Healthcare LLC: SIGNA Premier systemsApril 8, 2026
GE Healthcare SIGNA Premier whole-body MR scanners subject to Class II recall affecting 41 units due to ferrous fittings that may cause personnel injury during service procedures near active magnets.
- Intuitive Surgical, Inc.: Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da Vinci S, Si Permanent Cautery Hook Instrument Model/Catalog Number: 420183 Software Versio...April 8, 2026
Intuitive Surgical da Vinci S and Si Permanent Cautery Hook instruments (Model 420183) are subject to a Class II recall affecting 6,152 units nationwide and internationally due to frayed or broken pitch cables on reusable surgical instruments.
- Burlington Medical, LLC: Burlington Medical, Wrap Aprons and 12 other productsApril 8, 2026
Burlington Medical recalls 5,198 units of wrap aprons and related Class II products worldwide due to potential attenuation degradation that may shorten product lifespan.
- Amneal Pharmaceuticals, LLC: Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in cartons of 12 x 100 mL IV bagsApril 8, 2026
Amneal Pharmaceuticals recalls 784 cartons of mislabeled Magnesium Sulfate IV bags nationwide that contain Tranexamic Acid instead, posing serious health risks.
- K.C. Pharmaceuticals, Inc: Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 mL) bottles; a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 4...April 8, 2026
K.C. Pharmaceuticals artificial tears eye drops (589,848 bottles nationwide) are subject to a Class II recall due to lack of sterility assurance, which may cause temporary or reversible health problems.
- Intuitive Surgical, Inc.: Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci S, Si Mega Needle Driver Instrument Model/Catalog Number: 420194 Software Version: NA P...April 8, 2026
Intuitive Surgical recalls 7,819 da Vinci S and Si Mega Needle Driver instruments worldwide due to broken or frayed grip cables that may cause temporary health problems.
- Synthes (USA) Products LLC: 2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US and 1 other productApril 8, 2026
Synthes USA Products recalls 77 units of 2.4 Volt Tap Locking Screw Tap (Class II) due to lot swap resulting in incorrect threading; distributed nationwide across 22 states.
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Vue Motion V12. Product Number: 1017979April 8, 2026
Philips Medical Systems recalls 3,552 Vue Motion V12 ultrasound systems (Product 1017979) worldwide due to potential frame sequencing errors during dynamic imaging that may cause temporary health complications.
- Pocas International Corp.: POPPING BOBA RTD MIXED BERRY HIBISCUS TEA 12 X 13.8OZ and 3 other productsApril 8, 2026
Pocas International Corp. recalls 148 cases of popping boba ready-to-drink beverages distributed across nine US states and Canada due to packaging integrity issues that may compromise product quality.
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