FDA medical device recalls

Philips has identified an unintended radiation issue affecting Philips Brilliance iCT, Brilliance iCT Upgrades, and Brilliance iCT SP CT scanner systems running software version 4.1.10.x. This issue could affect the performance and safety of the equipment.

Karl Storz Flexible Hystero-Fiberscope Kits with certain serial numbers contain expired single-use endoscopic seals that may not maintain sterility during gynecological procedures. The affected seals expired in January 2023 and were distributed across 15 U.S. states.

The SafeOp Patient Interface (REF: AIX11240), part of the SafeOp 3 Neural Informatix System used during spine surgery, can lose or drop its nerve monitoring signal due to a software problem. When this happens, the device may show system errors, lose connection to the surgeon's tablet, and require a restart—potentially extending surgery time or changing the surgical plan.

Medline Industries is recalling nine types of surgical convenience kits that contain BD PurPrep solution. The solution may be contaminated with low levels of Bacillus species, a bacterium that could pose a risk if the kits are used in sterile procedures. The recall affects specific lot numbers of joint, spine, and neurological surgery kits distributed to hospitals and surgical centers in ten U.S. states.

Medline Industries recalled specific NEURO PACK medical convenience kits because the included BD PurPrep 26 mL solution may contain low levels of Bacillus species bacteria. The contamination was identified in kits distributed to hospitals and medical facilities in 10 U.S. states.

Medline Industries is recalling three types of medical convenience kits (Shoulder Pack and Major Ortho Kit models) because the BD PurPrep solution included in them may contain low levels of Bacillus species bacteria. The contamination was discovered in specific lot numbers distributed across ten U.S. states.

Medline Industries is recalling specific pediatric open heart and cardiac surgical convenience kits that contain BD PurPrep solution potentially contaminated with low levels of Bacillus species. The affected kits were distributed to healthcare facilities in 10 states. No injuries have been reported.

Medline convenience kits containing Bard Silastic Foley Catheters (sizes 16, 18, and 20 French, 5cc balloons) have been recalled because the catheters have an increased amount of raw material on their surface. This contamination may cause staining and could be harmful if the catheters are used.

Medline convenience kits containing Bard Silastic Foley Catheters (sizes 16, 18, and 20 French, 5cc balloons) have been recalled because the catheters have an increased amount of raw material on their surface. This material may cause staining and could potentially be harmful if the catheters are used.

Medline convenience kits containing Bard Silastic Foley Catheters (sizes 16, 18, and 20 French, 5cc balloons) have been recalled. The catheters contain increased amounts of raw material on the surface, which may cause staining and could be harmful if the catheters are used.

Medline convenience kits containing Bard Silastic Foley Catheters (sizes 16, 18, and 20 French, 5cc balloons) include catheters with excess raw material on the surface. This material may cause staining and could be harmful if the catheters are used.

Medline convenience kits containing Bard Silastic Foley Catheters (sizes 16, 18, and 20 French, 5cc balloons) have been recalled due to increased raw material on the catheter surface. This contamination may cause staining and could potentially be harmful if the catheters are used.

Medline convenience kits containing Bard Silastic Foley Catheters (sizes 16, 18, and 20 French) have been recalled because the catheters have an increased amount of raw material on their surface. This contamination may cause staining and could be harmful to patients.

Medline convenience kits used in urology robotic procedures contain Bard Silastic Foley Catheters with excess raw material on the catheter surface. This material may cause staining and could potentially harm patients. The catheters were originally recalled by the manufacturer due to this manufacturing defect.

Medline convenience kits containing Bard Silastic Foley Catheters have been recalled because the catheters have an increased amount of raw material on their surface. This material may cause staining and could be harmful if the catheters are used.

Medline convenience kits containing Bard Silastic Foley Catheters (sizes 16, 18, and 20 French, 5cc balloons) have been recalled because the catheters have an increased amount of raw material on their surface. This contamination may cause staining and could be harmful if the catheters are used.

Medtronic MiniMed Go app versions 1.0.0 and 1.1.0 have a software bug: when the "Set day and night" feature is turned off, missed-dose and high-glucose alerts may fail to trigger at night. This means users may not realize they've missed insulin doses, potentially delaying treatment and raising blood sugar levels dangerously.

Emano Flow, a smartphone app that measures urinary flow rate and volume, produced inaccurate results during a two-month period (March 22–May 29, 2026). The app recorded audio at an incorrect frequency setting, causing measurements to be systematically over-reported. The company has provided corrected results to healthcare teams.

The Olympus UHI-4 insufflation unit may experience unexpected shutdowns where the front panel display turns off and air delivery stops during use. This affects about 3,087 units distributed worldwide. No injuries have been reported.

The SnapshotGLO device's software cannot recognize when its battery has fully discharged into a low-power shipping mode. When this happens, the device will not resume charging when plugged in and becomes temporarily unusable until the issue is corrected.

Micro Therapeutics Pipeline Flex Embolization Devices have incorrect labeling on some units. Devices labeled as 3.0 mm x 20 mm actually contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm actually contain 20 mm implants. This mismatch could lead to incorrect implant selection during surgery.

Certain Halyard STANDARD LINE INSERTION PACK kits (Model PVHM234-01) have a defect in the silicone seal that may not seal properly. This defect can cause the seal to dome inward, potentially blocking fluid flow or allowing fluid to leak where it shouldn't.

The TheraSphere 360 Y-90 Management Platform has a software bug that can cause incorrect dose calculations. When a user modifies calculation inputs and recalculates, the new dose is computed correctly on screen, but vials previously added to the cart do not automatically update to match the revised calculation.

Penumbra System RED 68 Reperfusion Catheters (REF: RED68KIT) may fracture during use due to a manufacturing defect. The affected lots are H00008699, H00008701, H00008702, H00008703, and C00020038. These catheters were distributed worldwide, including throughout the United States.

Prismatik Dentalcraft distributed Silent Nite Sleep Appliances (a mandibular advancement device for snoring and sleep apnea) without obtaining required FDA clearance. The devices were sold in multiple states before the clearance status was identified.

Medtronic Neurosurgery's Ventriculostomy Kit (REF: 46154) may contain endotoxin levels higher than safe limits for devices that contact cerebrospinal fluid during brain surgery. Endotoxin exposure can trigger acute inflammation in the brain and nervous system.

The 3mensio Workstation software may report heart and vessel measurements that are 0.8% to 34% larger than the actual size when specific conditions are met: the software is used with access only to 3D Echo or Mitral 3D Echo features, and the analysis involves Philips 3D echo datasets that contain Color Doppler data. This could lead to incorrect clinical measurements used in patient care decisions.

Medline medical procedure kits used for knee and hip surgeries contain pain management medications with quality issues that could make them less effective. The affected kits were distributed to hospitals and surgical centers in Missouri, Colorado, and Illinois.

Medline medical procedure convenience kits (model HIP CDS-LF) contain pain management medications with quality issues that could make the medication ineffective. The affected kits were distributed in Missouri, Colorado, and Illinois. No injuries have been reported.

Certain Halyard EYE PACK convenience kits (Model LVEY27) contain Betadine solution at an incorrect concentration. The kits were distributed nationwide, primarily in California. No injuries have been reported.