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Slate Run Pharmaceuticals is recalling Eptifibatide Injection 75 mg/100 mL vials because the carton label says "weight-adjusted bolus dosing" when it should say "weight-adjusted infusion." This labeling error could lead to incorrect administration of the medication. No injuries have been reported.

Moderate·FDA·Mar 4, 2026·Slate Run Pharmaceuticals

AvKARE is recalling one lot of Amantadine HCl 100 mg capsules because they failed to meet dissolution specifications—meaning the capsules may not break down properly in the body, affecting how much medicine you receive. This is a quality issue identified during manufacturing testing. No injuries have been reported.

Moderate·FDA·Mar 4, 2026·AvKARE

LEO Pharma is recalling specific lots of Adbry, a prescription injection used to treat atopic dermatitis, because one unit was found to contain wool fiber particles. This contamination raises concerns about sterility and safety. No injuries have been reported so far.

Moderate·FDA·Mar 4, 2026·Leo Pharma

A software update (version P1.2.1) for the Intuitive Surgical Da Vinci 5 surgical system can cause the user interface to disappear from external or tower monitors during use. This affects 12 systems distributed in six U.S. states. No injuries have been reported.

Moderate·FDA·Feb 25, 2026

Stryker is recalling certain MOLLI 2 surgical marker systems because the instructions for use need to be updated. Magnetized surgical tools used during the procedure may dislodge the markers that are placed to mark the surgical site. Stryker is providing updated labeling to address this issue.

Moderate·FDA·Feb 25, 2026

Centinel Spine's Prodisc C SK cervical disc replacement devices were labeled as 6mm but actually contained 5mm products. This mislabeling affects 20 units distributed across eight states. The size difference could affect surgical fit and patient outcomes.

Moderate·FDA·Feb 25, 2026·Centinel Spine

Medline is recalling 42 convenience kits and procedure packs that were sterilized and packaged on equipment with calibration problems. The kits went through the validated sterilization and packaging cycles, but the calibration issues could affect how reliably they are sterile. No injuries have been reported.

Moderate·FDA·Feb 25, 202642 products

The MONARCH Platform bronchoscopy device has a software issue that can cause the robotic arm to move unexpectedly. If the application restarts after you select a position but before loading the bronchoscope, the system may reset to the left side even if you selected right, potentially causing the arm to contact the patient or breathing tube.

Moderate·FDA·Feb 25, 2026·Auris Health

Olympus is removing 12 versions of its Thunderbeat surgical energy device from the market because it has continued to receive reports of adverse events. About 107,000 units are affected, and the devices were sold in the US and in Brazil, Canada, Germany, Mexico, and Japan. The recall notice does not list any reported injuries.

Moderate·FDA·Feb 25, 202612 products

Medica Corporation's capillary tubes used with EasyBloodGas and EasyStat devices are giving false potassium results—up to 20% higher than actual levels. This could lead doctors to misinterpret a patient's potassium levels and provide incorrect treatment.

Moderate·FDA·Feb 25, 2026·Medica

Immunotech's Estrone RIA diagnostic kit may rarely produce falsely high hormone test results in patients. This could potentially lead to unnecessary or incorrect medical decisions. The issue affects only specific lot numbers and occurs very infrequently.

Moderate·FDA·Feb 25, 2026·Immunotech

Baxter Healthcare released 5 Spectrum IQ infusion pumps (model 3570009) without completing required safety tests, including tests of the occlusion alarm that alerts users to blockages. The pumps were distributed in Ohio. No injuries have been reported.

Moderate·FDA·Feb 25, 2026

Medline Industries is recalling 23 models of IV administration and extension sets because the male connectors may leak, crack, or break during use under certain conditions. This could cause delays in treatment, blood loss, infection, air embolism, or patients not receiving the correct medication dose.

Serious·FDA·Feb 25, 2026

Integra LifeSciences is recalling three wound dressing products, including MediHoney Gel, MediHoney Calcium Alginate, and a CVS private label dressing. The packaging may fail, which could break the sterile barrier and let the dressing become contaminated. No injuries have been reported.

Moderate·FDA·Feb 25, 20263 products

Wilson-Cook Medical is recalling certain Teslatome Bipolar Sphincterotomes (medical devices used during endoscopic procedures) because some units may contain a manufacturing defect—a void in the material that separates internal channels. This defect can cause electrical current to flow incorrectly during the cutting procedure.

Moderate·FDA·Feb 25, 2026

Olympus Corporation is recalling the High Flow Insufflation Unit (Model UHI) used during abdominal surgery due to a software problem that may cause overpressure events. The device is used to inflate the abdominal cavity and remove smoke during laparoscopic surgery. No injuries have been reported.

Serious·FDA·Feb 25, 20263 products

Why Not Natural Moringa Capsules (lot #A25G051, expiration 07/2028) may be contaminated with Salmonella, a bacteria that can cause serious illness. The affected capsules were distributed nationwide. No illnesses have been reported so far.

Serious·FDA·Feb 25, 2026

Steris Corporation identified that a limited batch of MNA-6x0 adapter components used in the Barco MNA with HexaVue IP Integration System were manufactured with an incorrect configuration file. This affects 10 units with specific serial numbers distributed across seven states.

Moderate·FDA·Feb 18, 2026

Surepulse Medical has recalled the VS Cap Extra Small (REF: SP-159-A1), a component of the VS Newborn Heart Rate Monitor, because the labeling includes an incorrect sizing guide. This labeling error could lead to improper cap selection for the device.

FDA·Feb 18, 2026·SurePulse Medical5 products

Certain da Vinci 5 Surgeon Console Viewer Displays have outdated firmware that may cause loss of the 3D surgical display or both displays entirely during surgery. When this happens, the surgical instruments remain active even though the surgeon cannot see the surgical field, which could result in unintended tissue contact, bleeding, or injury.

Serious·FDA·Feb 18, 2026

Philips is recalling eight Azurion 3, 5, and 7 X-ray system models. Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed, even when a table lock is active. No injuries have been reported.

Moderate·FDA·Feb 18, 20268 products

Alphatec Spine has recalled its ATEC Lateral Navigation Disc Prep Osteotome (10mm, model 266-01-000-10-N) used in spinal surgery due to an incorrect connection geometry in the navigated array. This defect could affect how the instrument connects to the Medtronic StealthStation navigation system during surgery. Seven units were distributed across 14 U.S. states.

Moderate·FDA·Feb 18, 2026·Alphatec Spine2 products

Certain Laerdal Compact Suction Unit 4 RTCA models made during a specific time period may emit electromagnetic noise above acceptable levels for aircraft use. No injuries have been reported. The affected units have specific catalog numbers: 880052, 880062, or 881152.

Moderate·FDA·Feb 18, 2026·Laerdal

Elekta's Leksell GammaPlan software version 11.1 has a bug that can cause incorrect radiation targeting during Gamma Knife treatment planning. If users don't update an old reference point before creating a new treatment plan, the radiation may be aimed at the wrong location. This error may not be caught during normal review.

Serious·FDA·Feb 18, 20262 products

Halyard TRANSPORT BAG KIT (Kit Code LIFE0080-01) may have a defective Tyvek bag seal that could compromise the sterility of the kit. The issue affects approximately 1,500 units distributed in New Jersey. No injuries have been reported.

Moderate·FDA·Feb 18, 2026

Straumann USA LLC recalled certain WB Impression Post Closed Tray kits because they contain magenta impression caps instead of the correct brown caps. This mix-up could lead to using the wrong component during dental implant procedures. The recall affects 561 units distributed nationwide.

Moderate·FDA·Feb 18, 2026

Medline is recalling 11 kit products that contain BD ChloraPrep Triple Swabsticks. BD found that the applicator packaging may have an open seal. No injuries have been reported.

Moderate·FDA·Feb 18, 202611 products

Medline is recalling seven groups of reprocessed heart and ultrasound catheters because they may contain small particles of leftover material. If these devices are used, the particles could cause inflammation, infection, or blood clots, which may lead to embolism or deep vein thrombosis. This is an expansion of an earlier recall, and the affected catheters were distributed nationwide.

Serious·FDA·Feb 18, 20267 products

Philips is recalling four CT scanner models because one or more of the 32 fasteners that attach the rotor to the gantry bearing may not be tightened to specification. If several fasteners are loose, rotor parts could become unsecured or displaced, and in theory could be expelled. The company reports no injuries and no observed parts being expelled during gantry rotation.

Moderate·FDA·Feb 18, 20264 products

Hologic's Brevera Breast Biopsy System disposable 9 gauge needles may contain tiny particles that could be deposited into breast tissue during a biopsy procedure. This affects approximately 681,870 units distributed nationwide. No injuries have been reported so far.

Moderate·FDA·Feb 18, 2026