Medical device recalls

Instrumentation Laboratory is recalling 141 units of two blood analysis systems: 32 GEM Premier 7000 with iQM3 units and 109 GEM Premier 5000 PAK units. The active ingredient concentration in the lysing bag solution did not meet manufacturing specifications, which could delay recognition and management of co-oximetry and total bilirubin abnormalities. The FDA classified it as Class II, and no injuries have been reported.

Moderate·FDA·Aug 12, 2026·Instrumentation Laboratory2 products

United Orthopedic Corp. is recalling three femoral offset bushings (0mm and 4mm, catalog 9323-5310, lot 25FC58) from its U2 Total Knee System. The implant's engraved numbering may be incorrect, which could lead to it being placed in the wrong orientation. The units were distributed in Texas and Michigan, and no injuries have been reported.

Moderate·FDA·Aug 12, 2026·United Orthopedic2 products

Aniara Diagnostica LLC is recalling its 5-PLASMA Bivalirudin AMR Verification Kit because stability issues were found with the reconstituted lyophilized human plasma and bivalirudin matrix. These issues cause measurable bivalirudin to degrade in the controls, calibrators, and linearity values. The kit was distributed in IL, NC, and TN, with no injuries reported.

Moderate·FDA·Aug 12, 2026·Aniara Diagnostica3 products

Philips is recalling 3 interventional X-ray system lines, sold as Philips Allura (including Allura Xper FD10 and Allura Centron), Philips Azurion, and Allura Centron, with about 8,610 units affected. The systems may contain unauthorized hard disk drives, which could cause loss of imaging, loss of motorized movement, or loss of data. No injuries have been reported.

Moderate·FDA·Aug 12, 2026·Philips3 products

Siemens Healthcare Diagnostics is recalling the Atellica CH Urine Albumin test (REF 11537225) used on CI analyzers. The test may produce falsely low urea nitrogen and hemoglobin A1c results, and may cause more quality control failures that delay results.

Moderate·FDA·Aug 12, 2026·Siemens

Beckman Coulter is recalling two MicroScan LabPro V5.03 Panel Update 11 products, an electronic update (REF D23352) and a DVD kit (REF D23354), for installation on MicroScan instruments such as the autoSCAN-4 and WalkAway-40 plus. The analyzers contain incorrect algorithms that may affect antimicrobial susceptibility test results and lead to false susceptibility classifications. The recall covers products distributed nationwide, including the listed states.

Moderate·FDA·Aug 12, 2026·Beckman Coulter2 products

Hardy Diagnostics is recalling HardyDisk AST Cefiderocol 30 µg (catalog Z9435) because incorrect cartridges were included in some units. This may lead to false-susceptible or false-resistant results, which could result in an ineffective antimicrobial being chosen. No injuries have been reported.

Moderate·FDA·Aug 12, 2026·Hardy Diagnostics

United Orthopedic is recalling four surgical knee instrument products, including U2 Total Knee System PSA box trials and femoral valgus adaptors, and USTAR II Knee System hinge box trials. An incomplete process on a component screw made by a subcontractor prevents the instruments from being assembled properly. The products were distributed nationwide, with distribution in Texas and Michigan. The notice reports no injuries.

Moderate·FDA·Aug 12, 2026·United Orthopedic4 products

Happiest Baby, Inc. is recalling refurbished pre-loved SNOO Smart Sleeper bassinets that failed to meet quality standards before they were distributed. The recall is being reported retroactively. The units were distributed in PA, WA, CA, and NJ, and 4 units are affected. No injuries have been reported.

Moderate·FDA·Aug 12, 2026·Happiest Baby

Siemens Healthcare Diagnostics recalled Lot U2 of its Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls because the sodium azide concentration is outside specifications. The company says assay results were not affected, and the health risk to lab technicians is low, with the worst expected outcome being mild skin or eye irritation.

FDA·Aug 12, 2026·Siemens

Lot U1 of the Syva Emit Disopyramide Enzyme Immunoassay calibrator has an out-of-specification sodium azide concentration. The notice says assay results were not affected, and the health risk to lab technicians is low, with the worst outcome being mild skin or eye irritation. No injuries have been reported.

FDA·Aug 12, 2026·Siemens

Boston Scientific is recalling Infinion CX lead kits used in its Spinal Cord Stimulator systems. The lead body may be exposed to stress at the anchor site, which may cause high impedance readings or lead fractures, possibly leading to inadequate stimulation and additional intervention, including lead removal and replacement. The recall covers 1,079 unused kits.

Serious·FDA·Aug 12, 2026·Boston Scientific

GE Healthcare is recalling Portrait Core Services software version 1.2.0 because a software vulnerability may allow unauthorized persons to gain privileged access to the device. This could result in loss of patient monitoring, missed patient alarms, or access to protected health information. No injuries have been reported.

Moderate·FDA·Aug 12, 2026·GE

Biofire Defense is recalling 122 kits (3,660 pouches) of the FilmArray NGDS Warrior Panel, a test that detects several dangerous pathogens in human whole blood. The firm found mismatches between the outbreak strain and the reference strain used to develop the test. The notice reports no injuries.

Moderate·FDA·Aug 12, 2026·Biofire Defense

GE Healthcare recalled certain MAC VU360 electrocardiograph units running software v3.0. After the order refresh icon is selected, a preview or review screen may not close automatically after 2 minutes of inactivity, so data from a previous patient could stay on screen and be linked to the next patient. No injuries have been reported.

Moderate·FDA·Aug 12, 2026·GE

Merge Healthcare is recalling 58 imaging workstations in two products: 53 units of Merge PACS and 5 units of Merge OrthoPACS. Thumbnails from a previously opened patient study may appear in the Thumbnail Bar while a different patient study is open. The FDA classified the recall as Class II. The notice reports no injuries. It covers US nationwide distribution and Canada and the UK.

Moderate·FDA·Aug 12, 2026·Merge Healthcare2 products

Zimmer Biomet is removing certain sizes of its Intramedullary Bone Saw Blade Assembly from use. The recall is due to potential damage to the sterile barrier packaging, which could leave the saw blade exposed. The notice reports no injuries.

Moderate·FDA·Aug 12, 2026·Biomet5 products

Stryker is recalling three tube set products: the AHTO Tube Set, the AHTO Dual Spike Tube Set and the Single Spike Tube Set. The FDA reports an increase in complaints describing leaking from the handpiece during use. The products were distributed in the US and in 17 other countries, and no injuries have been reported.

Moderate·FDA·Aug 12, 2026·Stryker3 products

Nuclein LLC is recalling the DASH Rapid PCR Instrument, model SG-0002 running software 6.0.2, because a software issue may produce false co-infection results, such as a positive for Flu A when SARS-CoV-2 is present. Two units were affected, and no injuries have been reported. The FDA has classified this as a Class II recall.

Moderate·FDA·Aug 12, 2026·Nuclein

Maquet Critical Care AB recalled certain Flow-i, Flow-c and Flow-e anesthesia machines after events were observed in which anesthetic agent was not delivered when the vaporizer was activated. The agency says this failure may result in a patient receiving insufficient anesthesia and may lead to intraoperative awareness. No injuries have been reported.

Moderate·FDA·Aug 12, 2026·Maquet

Innovasis, Inc. is recalling certain Vector anti-torque instruments (part LS-749) used with the Vector Pedicle Screw System for spinal fusion. The instrument may be undersized, which could prevent its mating tip from engaging the pedicle screw tulip and rod during tightening. This may lead to surgical delay or the use of alternative methods to complete the final tightening step.

Moderate·FDA·Aug 12, 2026·Innovasis

Medical Action Industries is recalling Dialysis Change Tray Clear Sequence kits (model 78791) that contain a needle-free access device with an improper seal. The seal may dome or tear. No injuries have been reported.

Moderate·FDA·Aug 12, 2026·Medical Action Industries

OXOS Medical is recalling 77 MC2 and MC2.1 portable X-ray systems, software version 5.7.0, because a defective circuit board can overheat. The units were distributed in Florida, Georgia, Indiana, South Carolina, Texas, and Virginia. No injuries have been reported.

Moderate·FDA·Aug 12, 2026·Oxos Medical

munevo GmbH is recalling munevo DRIVE and munevo DRIVE r-net powered wheelchair control systems because a software issue may cause the driving mechanism to fall out of calibration. This may cause unexpected steering drift or imprecise control, and the wheelchair may veer from its intended path, possibly causing a low-speed collision, tipping, or injuries to the user or bystanders. No injuries have been reported.

Moderate·FDA·Aug 12, 2026·Munevo

Theranica Bioelectronics is recalling Nerivio Infinity devices because the battery may have a thermal runaway event during charging, which could cause smoke and odor. No injuries have been reported. The notice does not describe a fix.

Moderate·FDA·Aug 12, 2026·Theranica

Copan's WASPLab, an automated device that incubates and digitally images agar culture plates with human microbiological specimens, has a WebApp software issue. The software may prevent users from overwriting results. No injuries have been reported.

Moderate·FDA·Aug 12, 2026·Copan

Quantum Rehab is recalling 10 powered wheelchair models and controller products, including Quantum 4Front 2, Quantum Outback, Q6 Edge 3 Stretto and Quantum Rival. If the "Remind Me Later" option is selected for user reminders, reminder pop-ups may appear during use. While driving, this may cause an unexpected park brake stop that could result in a fall or injury; while not driving, the control system may crash and stay in pre-operational mode.

Moderate·FDA·Aug 12, 2026·Pride Mobility10 products

Boston Scientific is recalling three Radial Jaw 4 biopsy forceps products (Standard Capacity, Large Capacity and Jumbo) for a potential breach in the sterile barrier of the device packaging. The notice reports no injuries, and the products were distributed across the US and internationally, with international distribution still pending.

Moderate·FDA·Aug 12, 2026·Boston Scientific3 products

Integrated Medcraft is recalling two first aid kits, the FORWARD Oral Airway Kit (REF 1011-40002) and the Kingfisher Compact Individual First Aid Kit (REF 76656), that contain one-piece Guedel airway components. The devices could potentially contain an occluded or partially occluded airway tip. No injuries have been reported.

Moderate·FDA·Aug 12, 2026·Integrated Medcraft2 products

The charging cradle for the Theragun G4 PRO massage device may overheat while charging the device's removable battery pack, which presents a risk of fire. The firm has received reports that the product caught fire, as well as reports of visible smoke, melting, charger burn, burning odor, and overheating. No injuries have been reported.

Serious·FDA·Aug 12, 2026·Therabody