Recent Food and Drug Administration regulations affecting small businesses

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.

Medline Industries recalls Class II thoracic robot kits containing defective Olympus biopsy valves that may shed rubber fragments into patients' airways, potentially requiring surgical removal.

Medtronic MiniMed insulin pumps across Paradigm, 600, and BLE 700 series are subject to a Class II recall due to unintended insulin over- and under-delivery caused by gravitational force changes when pump elevation relative to infusion site varies.

Civco Medical Instruments recalls 20 units of eTRAX Needle System Starter Kit and related products across Ohio, Pennsylvania, Washington, and China due to needle tip position detection errors that may cause temporary health issues.

Mentor Texas recalls Artoura Breast Tissue Expanders (Class II) due to potential dull or blunt needle tips that may be difficult to advance or break; affected units distributed worldwide including US, Canada, and multiple international markets.

Philips Medical Systems recalls 461 units (198 in US) of ALLURA Xper FD20 biplane X-ray systems due to wired foot switch malfunction that may prevent or intermittently disable imaging initiation.

Medline Industries recalls 9 kits (SKUs DYKM2720, ENFITDISCKIT, and one other) with ENFit G-tube connectors that may not seal properly due to dimensional specification failures, risking leakage and requiring clinical intervention.

Baxter Healthcare issues Class I recall of Blue Ventilator Adapter Module (Product Code M07937) for Volara Respiratory Therapy system due to risk of undetected oxygen desaturation or barotrauma in home care settings.

Imu-Tek Animal Health recalls 1,003 bottles of Colostrum-5 capsules distributed across 29 states due to potential under-processing that may cause temporary or reversible health problems.

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

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.

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

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

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 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.