Recent federal regulations affecting small businesses

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.

Amneal Pharmaceuticals recalls 784 cartons of mislabeled Magnesium Sulfate IV bags nationwide that contain Tranexamic Acid instead, posing serious health risks.

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.

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.

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.

Appco Pharma recalls 88,008 bottles of prazosin hydrochloride capsules nationwide due to excess nitrosamine impurities detected in manufacturing.

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.

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.

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.

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

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

Amneal Pharmaceuticals recalls 29,542 nationwide bottles of tramadol hydrochloride 50 mg tablets due to out-of-specification N-nitroso-desmethyl-tramadol impurity found during stability testing.

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.

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