FDA

Blueroot Health Expands Voluntary Recall of Vital Nutrients Aller-C Dietary Supplement Due to Undeclared Egg, Hazelnut, and Soy

Blueroot Health is expanding its voluntary recall of Vital Nutrients Aller-C dietary supplements to include all product from lot 25E04. The recall affects approximately 100 and 200 capsule bottles with lot numbers 25E04, 25E04-A, and 25E04-B, expiration date 05/27. The products were distributed nationwide from September 2025 through March 2026 and may contain undeclared egg, hazelnut, and soy allergens, posing a risk of serious or life-threatening allergic reactions.

Diagnostica Stago STA Liatest D-Di Recall — Positive Bias Issue

FDA issued Class II recall Z-1585-2026 for Diagnostica Stago's STA Liatest D-Di assay kits (REF 00515). Investigations confirmed a positive bias in D-Dimer measurements across the entire analytical range after customer complaints. The affected products were distributed US nationwide and internationally to Canada, Singapore, Guam, Japan, South Korea, and Russia.

ConvaTec EsteemBody Drainable Pouch Recall for Leaking Issue, 847 Units

FDA issued a Class II medical device recall for ConvaTec EsteemBody Drainable Pouch (REF:423643, 10-45mm) affecting 847 units. The recall was initiated due to potential leaking caused by a manufacturing defect. The affected products were distributed US Nationwide and internationally to countries including Australia, Canada, China, Germany, Italy, and others.

ConvaTec EsteemBody Drainable Pouch Recall - Manufacturing Defect

FDA has issued a Class II recall for ConvaTec EsteemBody Drainable Pouch (REF:423653, 10-35mm) due to a manufacturing defect causing the drainable large pouch to leak. The recall affects products distributed nationwide in the US and internationally to multiple countries including Australia, Canada, China, Germany, Italy, and others. The recall is ongoing.

LeMaitre Vascular Artegraft Vascular Graft Class II Recall

FDA issued a Class II recall for LeMaitre Vascular's Artegraft Vascular Graft (REF#: AG740) due to a labeling mix-up causing incorrect lot outer packaging. The affected products were distributed nationwide with presence in Illinois. Healthcare facilities with this product should identify and quarantine affected inventory.

Stryker Cub Pediatric Crib Model FL19H Recall

Stryker Medical Division of Stryker Corporation is recalling Cub Pediatric Crib, Model FL19H nationwide due to cribs sold in the USA missing two access door warning labels. The recall affects all units distributed within the US market. FDA has classified this as a Class II recall, indicating potential temporary or reversible health consequences if the hazard is not addressed.

GE Centricity Universal Viewer Software Cybersecurity Vulnerability Recall

GE Medical Systems is recalling Centricity Universal Viewer versions 5.0 SP6 through 5.0 SP7.1 due to a cybersecurity vulnerability exposing user login credentials on local client workstations. An unauthorized individual could potentially impact system availability and/or manipulate data. Healthcare facilities using this software should immediately identify affected systems and contact GE Medical for remediation options.

Abbott ID NOW Influenza A & B 2 Recall - Higher Invalid Rates, Z-1565-2026

FDA announced a Class II recall of Abbott Diagnostics Scarborough, Inc. ID NOW Influenza A & B 2 test kits (Model/Catalog Number: 427-000). The recall affects products with a higher occurrence of invalid rates compared to product Instructions for Use. Distribution was nationwide in the United States. The recall is ongoing.

Welch Allyn Spot Vision Screener VS100 Software Issue May Cause Screen Flicker Triggering Seizures

FDA issued a Class II recall for Welch Allyn Spot Vision Screener VS100 devices due to a software defect causing display screen flicker. The flickering may induce photosensitive seizure activity in susceptible individuals. Affected devices run software version 3.2.0.1 and are distributed nationwide across 15 US states plus Colombia and India. The recall is classified as ongoing.

GE Centricity Universal Viewer Software Cybersecurity Vulnerability Recall

FDA issued a Class II recall for GE Medical Systems Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1 due to a cybersecurity vulnerability. User login credentials may be exposed on local client workstations, potentially allowing unauthorized access that could impact system availability or enable data manipulation. The affected product displays medical images including mammograms from various imaging sources.