Recalls and safety alerts from the FDA, newest first.
FDA has received reports that the use of Mavyret, Zepatier, or Vosevi to treat chronic Hepatitis C in patients with moderate to severe liver impairment has resulted in rare cases of worsening liver function or liver failure.
The ventilator breathing circuits are intended to connect a ventilator to a patient tube or mask. Obstruction may result in inadequate ventilation
Nelson & Isa Lacteos LLC. of Bayshore, NY, is recalling 1lb packages of Requeson Cheese because they may be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems
The air-oxygen blender knob shaft on certain integrated and stand-alone Resuscitation systems can loosen, affecting the delivered oxygen concentration
GE HealthCare is correcting Carestations that may not ventilate properly in VCV mode. The issue is clearly indicated by alarms; other modes remain effective.
Ballester Hermanos está retirando un número limitado de bolsas de 5.99 OZ (170GR) de PEARL MILLING COMPANY ORIGINAL PANCAKE & WAFFLES (MEZCLA PARA PANQUEQUES Y WAFFLES) COMPLETE debido a la presencia no declarada de leche y soya. Las personas con alergia o sensibilidad grave a la leche y/o la soya c
WARREN, N.J., June 4, 2026 — Haleon (NYSE: HLN) is voluntarily recalling four lots of Gas-X Extra Strength Softgels 125mg, 120 ct. and 72 ct. distributed on or about April 13, 2026 to the consumer level. The lots are being recalled due to potential contamination with a diluted propylene glycol-based
Ballester Hermanos is recalling a limited number of 5.99OZ (170GR) pouches of PEARL MILLING COMPANY ORIGINAL PANCAKE & WAFFLES (MEZCLA PARA PANQUEQUES Y WAFFLES) COMPLETE due to undeclared milk and soy. People who have an allergy or severe sensitivity to milk and/or soy run the risk of a serious or
Target is voluntarily recalling Up & Up Fragrance Free and Up & Up Fresh Cucumber Scented Baby Wipes following customer complaints of product discoloration, and FDA testing that identified the presence of Burkholderia cepacia complex and Burkholderia gladioli in product samples.
Certain Omnipod Pods may have a tear in the tubing that allows insulin to leak outside the Pod instead of being delivered to the body.
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units. — AVEVA Drug Delivery Systems, Inc. · Class III · Ongoing · 59,808 pouches (4,272 Individual Folding Carton (IFC))
Failed Stability Specifications — AbbVie Inc. · Class III · Ongoing · 2,736 bottles
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station). — GE Medical Systems Information Technologies Inc · Class II · Ongoing
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints. — Medline Industries, LP · Class I · Ongoing
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints. — Medline Industries, LP · Class I · Ongoing
Retrospective submission for following issues identified: 1. Alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing were identified in certain AIC consoles. 2. There is improper alignment between the purge cassette and the motor drive in the AIC. This can result in a piston block event and lead to the inability to … — Abiomed, Inc. · Class I · Ongoing
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station). — GE Medical Systems Information Technologies Inc · Class II · Ongoing
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints. — Medline Industries, LP · Class I · Ongoing
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints. — Medline Industries, LP · Class I · Ongoing
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints. — Medline Industries, LP · Class I · Ongoing
Specific Medline Kits contain Cardinal Health Monoject 1mL Luer Lock Syringes, Tuberculin Print, Sterile. Cardinal Health has recalled these syringes because the outer carton and blister pack are labeled as a 1 mL Luer Lock Tuberculin Syringe (Product Code 1180100777), but the syringes inside are U-100 insulin syringes. — Medline Industries, LP · Class II · Ongoing
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints. — Medline Industries, LP · Class I · Ongoing
Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system. — Bolton Medical Inc. · Class I · Ongoing
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints. — Medline Industries, LP · Class I · Ongoing