Recent Food and Drug Administration regulations affecting small businesses

AYCO FARMS INC recalls 8,302 cartons of fresh cantaloupes due to potential Salmonella contamination distributed across PA, FL, CA, and NY in this Class I recall.

Medline Industries recalls 2,980 medical convenience kits containing NAMIC angiographic rotating adapter syringes due to risk of adapter unwinding causing disconnection during use; distributed nationwide in US, Puerto Rico, Canada, Netherlands, and …

Cook Medical recalls 20 units of Arterial Pressure Monitoring Trays (APMY series) distributed worldwide due to expiration date labeling exceeding true shelf life, posing temporary health risks.

FDA Class I recall of Blue Bull Extreme Male Enhancement Supplement by Pure Vitamins and Natural Supplements, LLC for undeclared sildenafil; distributed in New Jersey.

FDA determines BILTRICIDE (praziquantel) 600mg oral tablets were not withdrawn for safety or effectiveness reasons, allowing continued approval of generic versions meeting regulatory requirements.

FDA seeks 60-day public comment on information collection requirements for premarket approval of medical devices under the Paperwork Reduction Act.

FDA is withdrawing approval of GlaxoSmithKline's Wellcovorin (leucovorin calcium) tablets in 5 mg and 25 mg strengths due to the applicant's request following market discontinuation.

FDA requests 60-day public comment on information collection requirements for food and color additive petitions, master file submissions, and Form FDA 3503 electronic filings.

FDA seeks 60 days of public comment on proposed information collection requirements for color additive certification under the Paperwork Reduction Act.

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

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.

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.