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Abiomed is recalling 900 Impella heart pump controllers in three products: Automated Impella Controller, Impella Optical Controller, and Impella Connect Optical AIC. The units need hardware, firmware, or software updates found during a review of servicing records. Possible problems include the controller failing to recognize the purge cassette, a sticking push button that can cause loss of console control, start-up failure, and a software defect that can show incorrect negative pressure readings. No injuries have been reported.

Serious·FDA·Oct 28, 20263 products

JXK Enterprises, Inc. is voluntarily recalling Boner Bears Chocolate, Lot #BB21125, sold as a male enhancement product. FDA lab testing found sildenafil, the active ingredient in the prescription drug Viagra, which is not listed on the label. The product was sold nationwide online through www.elyxr.com.

Serious·FDA·Oct 28, 2026

Greenwich Rx is recalling 4,319 vials of its 200 mg/mL glutathione injection (10 mL multi-dose vials, for subcutaneous use only) because they may be contaminated with microbes. The recall covers 12 lots with beyond-use dates from October 2 to November 26, 2026, distributed nationwide. No injuries have been reported.

Serious·FDA·Oct 27, 2026·Greenwich Rx

Par Health USA's Argatroban Injection vials contain unwanted particles—including cellulose, polystyrene, plastic, stainless steel, or rubber stopper material—in the solution. The contamination affects multiple lot numbers distributed nationwide. No injuries have been reported.

Serious·FDA·Oct 26, 20262 products

Medtronic MiniMed CareLink Clinic software version 4.4A has a defect in its Settings Calculator feature. When healthcare providers enter custom insulin values, the calculator ignores them and continues using default values instead. This can result in incorrect insulin dose recommendations being sent to patients' insulin pumps, potentially causing patients to receive too much or too little insulin.

Serious·FDA·Oct 21, 2026

Medline distributed 165 open heart surgical convenience kits (SKU DYNJ902898D) with cannula components that don't meet required safety dimensions. The defective cannulas may leak or break during use, which could compromise patient safety during surgery.

Serious·FDA·Oct 21, 202612 products

Baxter Healthcare's Likorall overhead patient lifts may experience motor shaft breakage combined with reduced safety system performance, causing the lift strap to lower faster than expected during use. This malfunction could result in patient injury if a significant fall occurs.

Serious·FDA·Oct 21, 2026

The IOMAX Cortical Module, a medical device used for electrical stimulation testing, contains a defective printed circuit board that may cause the device to deliver electrical stimulation to a patient unintentionally or allow unwanted electrical current to reach the patient. The issue affects 23 devices with specific serial numbers distributed in the US and internationally.

Serious·FDA·Oct 21, 2026·Cadwell

Medtronic identified that donor tissue used in batch A62881 of Grafton DBM bone graft products tested positive for Clostridium butyricum bacteria and did not meet donor eligibility standards. Although the finished product passed sterility testing and underwent radiation treatment, there is a possibility of Clostridium infection if the product is implanted. Medtronic is retrieving all unused product from this batch.

Serious·FDA·Oct 21, 20262 products

Jenavalve Technology Inc. is recalling certain Trilogy Delivery Catheter devices (27MM, REF: TRILOGY-DC-L) because the sleeve liner may separate inside the catheter. This separation can make it difficult or impossible to properly deploy the heart valve device during surgery.

Serious·FDA·Oct 21, 2026·Jenavalve3 products

Instrumentation Laboratory is recalling two part numbers of the HemosIL AcuStar HIT-IgG(PF4) in vitro diagnostic test, 1,848 units in total. The test may produce an invalid calibration curve, or patient results may read up to 47% lower than they should. The recall covers US states and countries worldwide. No injuries have been reported.

Serious·FDA·Oct 21, 20262 products

Primal Herbs Volume, sold as a herbal supplement, contains sildenafil—a prescription medication—that is not listed on the label. FDA testing confirmed the presence of this undeclared ingredient. The product was sold online between July 2 and September 19, 2025.

Serious·FDA·Oct 21, 2026·Primal Supplements

Par Health USA's Dexmedetomidine HCl injection vials contain unwanted particulate matter, identified as cellulose or stopper material. The contamination affects two specific lots distributed nationwide. This is a prescription medication used during anesthesia and sedation.

Serious·FDA·Oct 21, 2026

Ventec Life Systems is recalling 12 ventilator products used for ventilatory support, including VOCSN+Pro, VC+Pro, VOCSN, VCSN+Pro, V+Pro, VC, V+ Pro Emergency and V*Home models, plus Japan versions. The flow transducer cable connector can disconnect from an internal board, which may cause the system to reboot and interrupt ventilation therapy. The recall covers US distribution and Japan and China, and no injuries have been reported.

Serious·FDA·Oct 20, 202612 products

The Philips Lumify portable ultrasound system may fail to recognize previously saved transducer settings, forcing re-registration that requires Wi-Fi or cellular access—unavailable in ambulances, aircraft, or remote field settings. Additionally, the USB cable connection between the transducer and tablet/phone may become unstable or disconnect, disrupting scans. These issues could delay diagnosis or treatment.

Serious·FDA·Oct 16, 2026

Nihon Kohden's CNS-6200 Series Central Nurse Station has a cybersecurity flaw that could allow someone to disrupt the system. If exploited, the flaw could prevent nurses from seeing patient monitoring data and alarms across multiple beds in a hospital.

Serious·FDA·Oct 14, 2026·Nihon Kohden

Some MiniMed Flex insulin pumps were shipped without completing required quality verification tests. These pumps may have problems including failure to work at startup, moisture damage, slow charging, connection issues with glucose monitors or the app, missed occlusion alerts, weak alarm sounds, or inaccurate insulin delivery.

Serious·FDA·Oct 14, 2026

Medline is recalling two bariatric basic steel rollator walkers, 2,659 units in total. The front wheel assembly can disconnect from the frame, causing the front wheels to become loose or detach during use, which could lead to falls and serious injuries such as head trauma or fractures. No injuries have been reported, and the products were distributed nationwide in the US and to Canada.

Serious·FDA·Oct 14, 20262 products

The FDA found that Omni Gold Anti-Marks Cream Extra Brightening, a skin-brightening product made in Pakistan, contains mercury. Mercury is toxic and can cause serious health problems when absorbed through the skin. The contaminated product was distributed nationwide through eBay.

Serious·FDA·Oct 14, 2026·DANALVIG LLC2 products

K.C. Pharmaceuticals is recalling eight sterile eye drop products sold nationwide because they may not be sterile. The products are sold under the Best Choice, Equaline, Good Sense, LEADER, exchange select and Crocodile Tears names. No injuries have been reported.

Serious·FDA·Oct 14, 20268 products

Centric Compounding of Houston, Texas, is recalling three sterile vitamin products sold as Tri-Immune Boost, Glutathione 200 mg/mL and Multidose Myers Cocktail vials. Test results found bacterial endotoxin levels outside acceptable limits. No injuries have been reported.

Serious·FDA·Oct 14, 2026·Centric Compounding4 products

Draeger has recalled its VentStar Resus Neo neonatal breathing circuit (Part Number MP00310) due to potential cracks in the hose. These cracks could cause air leakage or allow the hose to separate during use. The recall affects all lot numbers distributed nationwide and internationally.

Serious·FDA·Oct 7, 2026

Medline is recalling two products: hand control pendants and their wiring used with certain home care beds. The pendant or its wiring can overheat, which may cause smoking, sparking, melting, burning, or fire. About 771,127 units are affected, and the recall was expanded on 11/26/2025 to add products.

Serious·FDA·Oct 7, 20262 products

The tip of certain Boston Scientific Imager II Angiographic Catheters may fracture or detach during use. Fragments could remain in the patient's body or travel through blood vessels, potentially causing a prolonged procedure or life-threatening blood clot.

Serious·FDA·Sep 30, 2026

ICU Medical's 0.9% Sodium Chloride Injection (100 mL) may be mislabeled. Some bags marked as sodium chloride may actually contain potassium chloride instead. This mix-up affects lot 1042188, expiring 10/31/2027, distributed nationwide.

Serious·FDA·Sep 30, 2026

ICU Medical's CADD Yellow Medication Cassette Reservoirs may leak medication at the connection point between the luer connector and tubing. This leakage could delay or stop medication delivery, reduce the amount of medication received, expose patients to contamination, or allow air to enter the bloodstream.

Serious·FDA·Sep 23, 2026

Datex-Ohmeda is recalling four anesthesia system products, with 1,032 units affected. Certain gas mixer assemblies can automatically switch the system to Alternate O2 control, which delivers 100% oxygen and interrupts anesthetic agent delivery until a clinician intervenes. If that does not happen, the patient may experience decreased anesthetic effect. No injuries have been reported.

Serious·FDA·Sep 23, 2026·Datex-Ohmeda4 products

GE Healthcare is recalling six medical imaging and archive software products, with about 4,000 systems affected. Under certain conditions, historical imaging data moved from an older system can be linked to the wrong patient, so studies or images may appear in another patient's record. No injuries have been reported.

Serious·FDA·Sep 23, 20266 products

AVID Medical is recalling four Haylard procedure kits, about 2,300 in total, over possible product quality and sterility problems. The kits contain sodium chloride ampules that are also being recalled by Spectra Medical. The kits were distributed in Illinois, North Carolina, Virginia, and Wyoming, and no injuries have been reported.

Serious·FDA·Sep 23, 20264 products

Abiomed is recalling three groups of Impella controllers, about 10,750 units in total, that are used with heart pump systems. A component in the purge pressure sensor assembly, the purge flag, can fail, which may stop the controller from correctly recognizing the purge cassette. No injuries have been reported.

Serious·FDA·Sep 23, 20263 products