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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.
Alcon is recalling approximately 92,835 packs of contact lenses because a material quality issue may affect lens performance standards. Wearers may experience temporary eye irritation, redness, or blurred vision.
The DVOT SARS-CoV-2 & Influenza A+B Antigen Combo Test Kit (Model FAT01) has not obtained FDA authorization for sale in the United States. All lots distributed in the U.S. are subject to recall.
The DVOT SARS-CoV-2 Antigen Test Kit (Model FCY-AGT-01) manufactured by Feng Chun Yuan Medical Equipment has been recalled from the U.S. market because it was not authorized for sale in the United States.
Datascope's Cardiosave Hybrid IABP devices carry a risk of hemodynamic instability and clinical data transmission failure due to a software defect. Datascope has developed a software correction (Revision D.00) to mitigate this risk.
Datascope Corp. is issuing a software correction for CARDIOSAVE RESCUE intra-aortic balloon pump devices to address risks of hemodynamic instability and failure to properly transmit clinical data worldwide.
Smiths Medical is recalling paraPAC Plus 310 ventilators because the patient outlet connector may loosen or detach, potentially interrupting ventilation. Approximately 11,244 units worldwide are affected.
Datascope CARDIOSAVE Rescue IABP devices have a software defect that risks hemodynamic instability and clinical data transmission failure. A software correction is available.
Fresenius Kabi is recalling Ivenix Infusion System software (Version 5.9.1 and prior) due to anomalies that can cause pump malfunctions, alarms, or unresponsive screens while delivering medication, risking serious patient harm.
American Contract Systems recalled 280 units of its Day Surgery General Pack due to humidity control failures that prevent confirmation of adequate sterilization.
American Contract Systems is recalling Cath Lab Pack CECL02P medical kits because an inoperable chart recorder caused humidity readings to be out-of-specification, preventing confirmation that sterilization requirements were met.
American Contract Systems is recalling Nasal Sinus Pack units due to manufacturing control failures that prevent confirmation of sterilization. Affected units were distributed to multiple states.
Boston Scientific recalled 364 esophageal stent systems due to potential delivery catheter tip detachment during placement procedures. No injuries have been reported. Affected patients and providers should contact the manufacturer.
Boston Scientific is recalling the Agile Esophageal Over-the-Wire Stent System due to potential for delivery catheter tip detachment. Seven affected units distributed worldwide are identified by lot numbers 32889020 and 33178844.
Karl Storz Hopkins Telescope 6 endoscopes are being recalled because the instructions for use contain reprocessing procedures not reviewed or approved by the FDA. Affected units should not be used until corrected instructions are provided.
CooperSurgical is recalling Origio Sperm Wash Medium due to low sodium pyruvate concentration. The deficiency could compromise gamete development in assisted reproductive procedures.
Boston Scientific recalls Wallflex FC and Agile Esophageal Stent Systems due to the potential for delivery catheter tip detachment during use. Approximately 145 units are affected worldwide.
American Contract Systems, Inc. is recalling the Bilateral Tubal Ligation Pack (Lot 2405102) due to inability to confirm proper sterilization following a chart recorder malfunction.
Boston Scientific's Wallflex and Agile esophageal stent systems are recalled due to the potential for delivery catheter tip detachment. The recall affects 146 units distributed worldwide.
TMJ Solutions Inc is recalling the Stryker TMJ Unilateral Implant because patient-fitted prostheses contained incorrect components. Patients should contact their healthcare provider immediately.
Centinel Spine is recalling the Prodisc C SK cervical disc replacement due to blue discoloration on the inlay observed during assembly. This discoloration is a foreign contaminant that was not fully evaluated in manufacturing validations.
Cook Biotech is recalling 8 units of Biodesign Recto-Vaginal Fistula Plug devices because they expire before the date printed on the label. The affected products may lose sterility if used after actual expiration.
Boston Scientific recalls WallFlex and Agile esophageal stent systems (305 units) due to potential delivery catheter tip detachment. Affected products were distributed worldwide.
Philips recalls certain Ingenia 1.5T MRI devices due to loose assembly screws that may block the patient tabletop, potentially delaying diagnosis and causing patient anxiety.
Boston Scientific is recalling Wallflex and Agile Esophageal Stent Systems due to potential for delivery catheter tip detachment. The recall involves 124 units distributed worldwide.
Cook Biotech is recalling 35 units of Biodesign Fistula Plug surgical implants that expire before their printed expiration dates, potentially compromising device function.
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