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FDA recalls of medical devices including diagnostics, implants, and consumer health hardware.
Medical device recalls are the FDA's highest-volume stream. They cover implantable devices like pacemakers and joint replacements, hospital diagnostics and lab analyzers, surgical instruments, software-as-a-medical-device, and consumer-facing hardware like CPAP machines, blood-pressure cuffs, and glucose monitors. The volume comes from the wide range of products in scope and from the FDA's broad definition of 'corrective action' — software updates, IFU revisions, and labeling corrections all show up as recalls.
For Class I device recalls, the device's defect creates a reasonable risk of serious injury or death — these are the urgent ones. Class II covers issues that may cause temporary or medically reversible harm, often around accuracy or calibration. Class III is for products that don't comply with FDA rules but pose no real safety risk; in practice many software-update letters are Class III.
If you depend on a recalled device for ongoing care, don't disconnect or stop using it before talking to the prescribing clinician — interrupting therapy for a CPAP or a continuous glucose monitor can be more dangerous than the recall it's responding to. Almost every device recall offers a remedy that doesn't require you to surrender the device first.
FUJIFILM is recalling Synapse PACS Version 7.2.100 because the medical imaging software produces incorrect measurements when analyzing certain breast images. Affected healthcare facilities using this software version should verify measurement accuracy in their systems.
Synthes is recalling 47 VA-LCP Clavicle Plate 2.7 bone fixation implants (Lot 1201P12) distributed worldwide because sterility cannot be confirmed. Non-sterile surgical implants pose risk of infection.
Synthes has recalled 17 units of 1.5MM surgical drill bits worldwide because the products could not be confirmed as sterilized, posing an infection risk during orthopedic procedures.
Synthes is recalling 10 units of RAPIDSORB IPS Battery Pack Sterile because the products cannot be confirmed as sterile. The affected lot was distributed worldwide to medical facilities. Patients should consult their healthcare provider about replacement options.
Invacare Corporation is recalling approximately 8,117 bed component units nationwide due to a potential weld defect that may cause premature weld failure.
Howmedica Osteonics Corp. is recalling X3 Triathlon inserts due to potential breaches in sterile packaging. The breach could compromise device sterility and allow contamination if the affected units are used.
Aesculap Inc recalls Disposable Hasson Trocars (EK240SU) due to potentially damaged sterile packaging that may compromise sterility. Batch 52581648 distributed in KS, NJ, NY, and Canada requires immediate discontinuation.
Howmedica Osteonics recalls 143 units of the X3 Triathlon CS Insert No. 6 (10 mm) due to potential breaches in inner and outer sterile blister packaging that could compromise product sterility.
Waldemar Link is recalling Embrace Drill Tower surgical instruments due to mixed-up type descriptions ("standard" vs "wedged") in the accompanying surgical technique documentation.
Synapse PACS Version 7.1.000 medical imaging software produces incorrect measurements when Secondary Capture 2D images without pixel spacing are combined with Breast Tomo Series data.
Micro Therapeutics is recalling Apollo Onyx Delivery Microcatheter devices with incorrect indications for use. European-version devices were distributed in the U.S. across 29 states.
Synthes is recalling 144 units of RIA Tube Assembly surgical instruments due to sterility failure. The devices cannot be confirmed as sterile and pose a risk of infection if used in orthopedic procedures.
A software defect in VITROS XT 3400 Chemistry Systems prevents quality control rules from properly reporting failures in test controls. This may result in erroneous patient test results being reported.
A software defect in VITROS 4600 Chemistry Systems causes quality control baselines to not update when users change them, potentially causing erroneous patient results.
Waldemar Link recalled Embrace Drill Tower surgical instruments because type descriptions ("standard" vs "wedged") are mixed up in the product overview documentation. Surgeons may select incorrect instrument types due to the confusion.
Canon Medical's MRI systems display incorrect Spatial Field Gradient values that are lower than actual, which may cause discomfort for patients with MR-conditional implanted devices during scanning.
Ventec Life Systems recalls VOCSN Patient Breathing Packages because the spiral wrap may detach during ventilation, compromising the breathing circuit and creating a risk of serious injury or death, especially for ventilator-dependent patients.
Medline Industries is recalling over 3,200 surgical kits and trays containing components that may lack sterility. The recalled products could pose infection risk to patients if used during surgical procedures.
Medline Industries is recalling 533 units of gynecological laparoscopy kits and trays manufactured with Nurse Assist irrigation and saline components due to potential lack of sterility. The affected products were distributed nationwide in the U.S. and internationally.
Medline is recalling approximately 3,900 medical device kits and trays nationwide due to potential sterility failures in irrigating solution components. The affected products may not be sterile, creating a risk of infection.
Medline Industries is recalling care and cleaning kits for tracheostomy and stomas due to component solutions that may not be sterile. The affected kits contain Nurse Assist-manufactured saline and irrigation solutions distributed in the U.S., Puerto Rico, Canada, UAE, and Panama.
Medline Industries is recalling Centurion LVAD maintenance kits and driveline management trays due to sterility concerns in irrigation solution components from Nurse Assist. The solutions may be non-sterile and could pose infection risks.
Medline Industries is recalling Wound Care Trays due to potential lack of sterility in solution components. The recall affects 72,624 units distributed nationwide and internationally.
Medline Industries recalls 576 units of Centurion Laceration Trays nationwide because Nurse Assist-supplied components may lack sterility, posing potential health risks in medical procedures.
Medline Industries recalls arterial irrigation bundles due to potential loss of sterility in Nurse Assist components, which could deliver non-sterile solutions for medical procedures.
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