FDA regulations

Abiomed recalls 33,107 Generation 1 purge cassettes distributed worldwide in Impella Pump Sets due to increased purge leak risk that may cause serious injury or death.

ReCor Medical's Paradise ultrasound renal denervation catheter (Model PRDS-068-02) is subject to a Class II recall affecting 24 units distributed across nine U.S. states due to nonconforming product that should have been scrapped.

Ultradent Products recalls 2,508 units of Jiffy Original Composite Polisher Cups (Coarse) distributed across the US and Puerto Rico due to potential crumbling that could delay patient treatment.

Reflexion Medical RefleXion X1 Radiotherapy System Model RXM1000 Class II recall affects 12 units in California and Texas due to software defect causing potential 5mm treatment displacement and 10-20% underdose during repeat localization procedures.

Philips Respironics issues Class I recall of 113,717 Trilogy Evo O2 ventilators and related devices nationwide due to obstruction alarm delay that may take up to four breaths to trigger.

Summa Therapeutics recalls 22 units of Finesse BTK Multicath injectable angioplasty balloon catheters nationwide due to potential balloon burst specification failures posing temporary health risks.

Medline Industries recalls 420 units of sterile radiology procedure kits (model DYNDH1491B) nationwide in Minnesota due to potential sterile pouch packaging breach that may compromise product sterility.

Stryker CHROMOPHARE Softlit Ring Surgical Light System recall affects 6,170 units worldwide due to ceiling cover support deficiency posing temporary health risks.

Cardinal Health recalls 198,900 tuberculin syringes (catalog 1180100777) distributed nationwide and in Canada due to mislabeled packaging containing U-100 insulin syringes instead.

The Maros Group recalls Prickly Pear Jelly (9 oz bottles) distributed in Arizona due to undeclared milk allergen; 24 bottles affected in Class II recall.

Lone Star Dairy Products LLC recalls 1,791,543.94 lbs of spray-dried dairy powder nationwide due to salmonella contamination identified in finished product testing.

JFE Franchising Inc. issues a Class II recall of vegetable dumplings due to potential glass contamination across 40 states including Alaska, California, and Texas.

HEYTEA USA Inc recalls 12,677 cartons of Coconut Drink 1 across seven states due to undeclared milk that may cause temporary health problems.

TG Foods Inc. recalls 7,980 units of Divided Sunset Multi Collagen Peptides nationwide due to missing allergen labeling for egg and fish species on the product.

Super World Trading Inc. recalls 595 cases of tangerine-flavored roasted peanuts distributed across 18 states due to banned cyclamate sweetener content.