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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.
The TRIDENTII HEMI CLUSTER58F hip implant acetabular shell may have excessive deburring creating a smooth edge. Howmedica Osteonics Corp. is recalling affected units.
IBA Proton Therapy System (PROTEUS 235) units recalled due to safety parameter failures that could prevent proper radiation control, risking unintended radiation exposure during cancer treatment.
Philips is recalling certain Patient Information Center iX Uninterruptable Power Supply devices due to potential power supply failures that could cause the monitoring system to shut down, risking delays in detecting patient condition changes.
ACUSON Maple ultrasound systems display the last cardiac measurement value instead of the configured minimum or maximum, potentially causing patient misdiagnosis during cardiac assessment.
Quidel Corporation is recalling 104,300 units of InflammaDry MMP-9 diagnostic tests due to misalignment of the test results window. Positive results may be hidden and not visible, potentially leading to false negative readings.
Howmedica Osteonics Corp. is recalling TRIDENTII HEMI CLUSTER66H hip implants because the acetabular shell may have excessive deburring, creating a smooth surface on the edge of the shell.
The Biomet OrthoPak Bone Growth Stimulator System is being recalled due to potential lead wire sheath damage that could prevent therapeutic signal delivery and delay patient treatment nationwide.
Siemens ACUSON Juniper ultrasound systems may display the wrong cardiac measurement value when configured to show minimum or maximum values, potentially leading to misdiagnosis.
The ACUSON Redwood 1.0 Diagnostic Ultrasound System may display the last measured cardiac value instead of the minimum or maximum value as configured, potentially leading to misdiagnosis or improper patient management.
FDA recalls PIEZON Bottle (Model EG-111) dental treatment bottles because certain units may separate into two parts when pressurized during treatment or storage. No injuries have been reported.
EBI, LLC is recalling 594 units of 48-inch lead wire replacement parts (part number 1067724-4) due to sheath damage that prevents therapeutic signals from reaching treatment electrodes.
Howmedica Osteonics Corp. is recalling TRIDENTII HEMI CLUSTER44B hip implants due to excessive deburring on the acetabular shell edge. The recalled lot was distributed nationwide and internationally.
Leica is recalling 98 HistoCore PEGASUS automated tissue processors due to a protocol configuration error that can produce poorly processed or damaged biopsy specimens.
Parker Laboratories is recalling Redux Electrolyte Creme, a highly conductive medical electrolyte product, due to demonstrated low viscosity.
Howmedica Osteonics is recalling the TRIDENTII HEMI CLUSTER54E hip implant due to excessive deburring on the acetabular shell edge that may affect implant performance. The recall involves 225 units distributed nationwide and internationally.
Certain Palindrome Precision HSI dialysis catheters do not have the heparin coating indicated on the label, which could reduce their protective benefits during dialysis procedures.
Howmedica Osteonics is recalling TRIDENTII PSL CLUSTER50D acetabular shells for hip replacements due to excessive deburring resulting in smooth edges on the shell.
Baxter Healthcare is recalling Seprafilm Adhesion Barrier units (165 units, Lot DBYSEP046) that were distributed nationwide without FDA approval. Affected units distributed in LA, GA, IN, VA, FL, NY, and CA.
Select lots of 3M Durapore Surgical Tape (Catalog Number 1538-118) were labeled with a 5-year shelf life when the actual shelf life is 3 years. The recall affects over 3.5 million rolls distributed worldwide.
Draeger Medical is recalling approximately 16,841 Dräger Perseus A500 Anesthesia Workstations due to unexpected shutdown while operating on battery power. The devices have been distributed nationwide and internationally.
Philips Respironics is recalling 789 Trilogy Evo O2 ventilators due to a software defect that can trigger a false power alarm despite sufficient power, potentially causing sudden loss of ventilation in pediatric and adult patients.
Elekta recalled disposable biopsy needles from batch 837838839 that may contain microscopic stainless steel debris inside. The sterility of the needles has not been affected, and this issue has been reported from only one site.
Philips Respironics is recalling the Trilogy Evo ventilator (76,713 units) because it may suddenly stop ventilating when a false Battery Depleted or Loss of Power alarm triggers despite sufficient power available.
Philips is recalling 56,012 Trilogy EV300 ventilators due to a software defect that can trigger a false Battery Depleted or Loss of Power alarm despite adequate power, risking sudden loss of ventilation.
Outset Medical is recalling Tablo Hemodialysis Systems because their silicone tubing may contain unremoved polychlorinated biphenyl acids (PCBAs), which could cause skin conditions, liver damage, reproductive harm, or cancer.
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