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Specific lots of Medline reprocessed St. Jude Medical Response diagnostic electrophysiology catheters may contain small particles of residual material on surfaces that contact patients. If these particles dislodge during use, they could potentially cause blood clots, inflammation, or infection.

Serious·FDA·Jul 8, 2026

Medline Convenience kits contain Swan-Ganz catheters with a defective connector (blue hub) that can leak, break, or damage the internal lumen. This defect may lead to medication loss, blood loss, or infection during medical use.

Serious·FDA·Jul 8, 20268 products

Insulet is recalling three Omnipod pod lines (Omnipod 5, Omnipod DASH, and Omnipod Eros), about 7 million units in total. Damage to the soft cannula during manufacturing can let insulin leak around the pod instead of being delivered, so users may get too little insulin. This can cause high blood sugar, and in severe cases prolonged high blood sugar can lead to diabetic ketoacidosis, hyperglycemic hyperosmolar syndrome, or death. No injuries have been reported.

Serious·FDA·Jul 8, 2026·Insulet3 products

Certain coaxial breathing circuit sets used with Hamilton Medical ventilators (models C1, T1, and MR1) may have expiratory valve membranes that stick to the valve body. This defect is not always detectable before use and can trigger an "exhalation obstructed" alarm during ventilation, potentially leading to inadequate ventilation and oxygen desaturation in patients.

Serious·FDA·Jul 8, 2026·Hamilton Medical AG

MOGO Pure Moringa Oleifera capsules may be contaminated with Salmonella Typhimurium. The contamination was discovered during testing. Affected bottles were sold online through Amazon, eBay, Etsy, and mogomiranga.com.

Serious·FDA·Jul 8, 2026

Abiomed is recalling four Impella CP product sets that include 14 Fr Low Profile Introducer Kits, with 195 affected units in total. The introducer may form blood clots (thrombus) during prolonged use. No injuries have been reported, and the distribution covers the US states of FL, IL, MN, NJ, NY, and VA, plus Japan.

Serious·FDA·Jul 1, 20264 products

Ventec Life Systems' VOCSN+Pro respiratory ventilator may have a damaged backup battery that powers the alarm system. If primary power is lost and the backup battery is depleted or absent, the backup alarm may not sound to alert caregivers of the power loss.

Serious·FDA·Jul 1, 2026

Certain Da Vinci surgical systems were distributed with a defective E-brake retainer pin. If the structural column fails, this pin can prevent the E-brake from engaging, potentially causing uncontrolled motion of the robotic arm. The pin may also loosen or back out, restricting arm movement or causing uncontrolled motion that could injure patient tissue.

Serious·FDA·Jul 1, 2026

Medline is recalling four groups of convenience kits, 7,738 units in total, because they include lidocaine and bupivacaine injections from supplier Arrow. Those injections were recalled after an FDA inspection of the supplier found quality issues. No injuries have been reported.

Serious·FDA·Jul 1, 20264 products

BD ChloraPrep Clear, a sterile antiseptic skin-prep solution used before medical procedures, was found to contain Aspergillus penicillioides fungus in some applicators. This affects the sterility of the product, which is critical for medical use. The affected lot is Lot #4032183 with an expiration date of January 31, 2027.

Serious·FDA·Jul 1, 20264 products

Thoratec is recalling three HeartMate products: HeartMate 3 Left Ventricular System kits, System Controllers, and HM 11V Li-ion Backup Batteries. The 11-volt backup batteries can fail. No injuries have been reported.

Serious·FDA·Jun 24, 20263 products

The Mito Red Light Super Mobile near-infrared therapy device contains a lithium-ion battery that may malfunction and catch fire or burst into flames. The device has been distributed worldwide, including across the United States.

Serious·FDA·Jun 24, 2026

AMD Medicom Inc. is recalling Ritmed Neurological Sponges (0.75x0.75in, Sterile, REF: 85995C) used during brain surgery because some units may not meet safety standards for endotoxin—a bacterial byproduct that can cause harmful reactions in the cerebrospinal fluid. Elevated endotoxin levels could lead to fever, inflammation, low blood pressure, nausea, or neurological complications.

Serious·FDA·Jun 24, 2026·AMD Medicom2 products

Abiomed's Impella CP Set with SmartAssist may experience low purge pressure issues that trigger repeated alarms. In some cases, this malfunction can interrupt or stop the device's mechanical heart support function.

Serious·FDA·Jun 24, 2026

Arrow is recalling 35 kits and sets that contain lidocaine, bupivacaine, or 0.9% sodium chloride from a supplier that was itself recalled for quality issues. If the sterility of these water-based injectable drugs is compromised, it could lead to serious or life-threatening injuries. No injuries have been reported, and the products were distributed nationwide.

Serious·FDA·Jun 24, 2026·Arrow35 products

A software error in certain Automated Impella Controller devices (used to manage left heart support blood pumps) may affect device function. The error affects controllers with software versions 6.0.1, 6.0.2, 6.0.3, 7.1 and above across multiple regions worldwide.

Serious·FDA·Jun 24, 2026

A component in certain Giraffe and Panda warming systems can loosen during maintenance, causing the device to deliver oxygen at a concentration different from what the clinician set. This can result in too much oxygen (hyperoxia) or too little oxygen (hypoxia) being delivered to the patient.

Serious·FDA·Jun 24, 2026·Datex-Ohmeda3 products

Ajanta Pharma USA Inc. distributed bottles labeled as Aripiprazole 30 mg that actually contained Voriconazole 50 mg, a different medication used to treat fungal infections. This mix-up affected 6,143 bottles (Lot PA00805, expiring 01/31/2029) distributed nationwide. The error was discovered and reported to the FDA.

Serious·FDA·Jun 24, 2026

Total Nutrition Inc is recalling TNVitamins and Doctor's Pride brand moringa capsule supplements because they may be contaminated with Salmonella. The recall affects 13,000 bottles sold nationwide across multiple lot numbers.

Serious·FDA·Jun 17, 2026

Gas-X Extra Strength softgels were contaminated with a diluted propylene glycol-based coolant during packaging due to a machine leak. The contamination affected specific lot numbers distributed nationwide. No injuries have been reported.

Serious·FDA·Jun 17, 2026

Sun Pharmaceutical's doxorubicin hydrochloride liposome injection vials were found to contain glass particles. The affected vials are lot HAG2581B, which expire in May 2027. About 675 vials were distributed nationwide.

Serious·FDA·Jun 17, 2026

Beekeeper's Naturals is recalling one lot of its Saline Nasal Spray sold on Amazon because it contains elevated levels of yeast and may be contaminated with Aspergillus, a fungus that can cause serious infections in people with weakened immune systems or lung disease. The company has received four reports of sinus congestion, irritation, or infection potentially linked to this product.

Serious·FDA·Jun 11, 2026·Beekeeper's Naturals

GE HealthCare recalled six ApexPro CARESCAPE Telemetry Server products and related software. A persistent NO COMM or OFF NETWORK condition at the Central Station could cause loss of ECG and SpO2 monitoring. No injuries have been reported.

Serious·FDA·Jun 3, 20266 products

Certain Impella Controller (AIC) consoles contain electrical faults including alarm failures, power-path problems, and inaccurate motor sensing. Additionally, improper alignment between the purge cassette and motor drive can prevent the purge system from priming correctly, requiring users to switch to a backup console.

Serious·FDA·Jun 3, 2026

Medline is recalling seven procedure kit products that contain bupivacaine hydrochloride in dextrose injection made by Huons Co. That bupivacaine was itself recalled over quality problems, including questions about microbiology testing data and reports of reduced effectiveness. No injuries have been reported.

Serious·FDA·Jun 3, 20267 products

Abiomed identified that certain Automated Impella Controller (AIC) units have internal hardware issues that could affect device operation. These include cable and component positioning problems that may interrupt motor controls, cause startup failures, or prevent the device from booting properly. Abiomed is implementing hardware updates through its servicing process.

Serious·FDA·Jun 3, 2026

The proximal clasp on Bolton Medical's RelayPro Thoracic Stent-Graft System may disconnect from the outer control tube during use. This disconnection could prevent the stent graft from being released properly from its delivery system. The FDA has issued a labeling update to inform physicians and hospitals of this potential issue.

Serious·FDA·Jun 3, 2026·Bolton Medical

Wellnov Supplements LLC is recalling Liposomal Collagen Booster liquid supplement due to manufacturing process deviations that could allow bacterial contamination, including the risk of C. botulinum. The product was distributed nationwide and in Puerto Rico between June 2025 and April 2026.

Serious·FDA·May 27, 202614 products

Liquid Blenz Immunity Enhancer Elderberry syrup (16 oz and 32 oz bottles) may not have been properly processed, which could allow Clostridium botulinum bacteria to grow. This bacterium produces a toxin that causes botulism, a serious illness. The product was distributed in New York and through online sales.

Serious·FDA·May 27, 2026·Liquid Blenz13 products

Wisconsin Pharmacal Company's MG217 Multi-Symptom Treatment Cream (colloidal oatmeal 2%, 6 oz) has been found to contain Staphylococcus aureus bacteria. The contamination was confirmed in lot #1024088 (expiration 11/30/2026). About 690 tubes were distributed nationwide and to the Bahamas.

Serious·FDA·May 27, 2026·Wisconsin Pharmacal