FDA: Device Recalls Class II

Siemens Atellica CH A1c_E Recall - Class II

FDA Class II recall targets Siemens Atellica CH Enzymatic Hemoglobin A1c (A1c_E) test due to potential for falsely depressed hemoglobin A1c results when processed on the same analyzer as RCRP. The frequency and magnitude of negative bias increase over time. Affected parties include laboratories using shared analyzers for both tests. Separate analyzer use eliminates the issue.

eTRAX Needle System Starter Kit 18G Class II Recall - Sensor Programming Error

FDA issued a Class II recall of Civco Medical Instruments Co. Inc.'s eTRAX Needle System Starter Kit 18G (Part Number 667-152) for Aurora Trackers. The recall stems from an inspection and programming error in the eTRAX needle sensor that may cause the needle tip position to be incorrectly identified on the user interface. Affected products were distributed in US states Ohio, Pennsylvania, and Washington, as well as China. The recall is ongoing.

Medtronic MiniMed 780G Insulin Pump Class II Recall

Medtronic MiniMed, Inc. initiated a Class II recall for MiniMed 780G Insulin Pumps (models MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896) and related Paradigm, 600 series, and BLE 700 series infusion pumps. The pumps were found to deliver insulin incorrectly when elevated or lowered relative to the infusion site due to gravitational force changes affecting delivery accuracy. Affected products were distributed worldwide and nationwide in the United States across multiple states including CA, TX, FL, NY, and others.

Mentor Texas Artoura Breast Tissue Expander Recall - Blunt Needle Risk

FDA classified a Class II recall of Mentor Texas LP Artoura Breast Tissue Expanders (Reference Numbers TEXP110RH through TEXP150RH) due to infusion sets potentially containing dull or blunt needle tips that may be difficult to advance and/or may break. The recall is ongoing with worldwide distribution including US nationwide and multiple international markets.

Olympus SOLTIVE Premium Laser System Class II Recall - Power Supply Module Defect

FDA announced a Class II recall of Olympus SOLTIVE Premium SuperPulsed Laser Systems (model TFL-PLS) due to a potential defect in the 24V power supply module. The defect may cause the system to become inoperable and produce smoke or a burning smell. The recall affects units distributed US Nationwide and internationally to Canada, Chile, Europe, Singapore, Australia, and Hong Kong. The recall is ongoing.

Medtronic MiniMed Insulin Pump Recall - Paradigm Veo Z-1752-2026

Medtronic MiniMed, Inc. is recalling Paradigm REAL-Time Veo Insulin Pumps (MMT-554, MMT-754) and all Paradigm series, 600 series, and BLE 700 series infusion pumps due to unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site because of gravitational force changes. The FDA has classified this as a Class II recall affecting devices distributed worldwide including US nationwide.

ReCor Paradise Renal Denervation Catheter Class II Recall

FDA classified a Class II recall of ReCor Medical Inc.'s Paradise™ Ultrasound Renal Denervation System catheters (Model PRDS-068-02). The firm initiated the recall after distributing a nonconforming product that was supposed to be scrapped and not intended for human use. The device is an ablation catheter used for renal denervation. The recall affects units distributed nationwide in CA, CO, FL, KS, MO, NC, OH, TX, and VA. The recall is ongoing with no specified end date.

Thoracic Robots Contain Recalled Olympus Biopsy Valves

FDA classified a Class II recall for Medline Industries Thoracic Robots kits (DYNJ908777B) that contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints of rubber fragment detachment in the slit of single-use biopsy valves, posing a risk of foreign body in patients. Affected kits were distributed nationwide across CA, FL, IL, IN, KY, MA, MD, MT, NY, OH, PA, TN, and TX. The recall is ongoing.

ALLURA Xper FD20 Biplane System Wired Foot Switch Recall

Philips Medical Systems is recalling the ALLURA Xper FD20 Biplane X-ray system due to a defect in the wired foot switch that may prevent X-ray imaging from initiating or cause it to occur intermittently. The recall affects systems with product codes 722008 and 722013 and is classified as Class II. Users should stop using the wired foot switch and contact Philips for a replacement or workaround.

Intuitive Surgical da Vinci Cautery Hook Class II Recall

Intuitive Surgical, Inc. initiated a Class II recall of the da Vinci S, Si Permanent Cautery Hook Instrument (Catalog #420183) due to increased complaints of frayed or broken pitch cables on reusable surgical instruments. The recall affects devices distributed nationwide across 24 U.S. states. The recall status is ongoing as of April 8, 2026.