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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.
Energizer Personal Care is recalling Playtex Deluxe Double Electric Breast Pumps because loose power adapter casings may cause electric shock.
Intuitive Surgical is recalling 5,217 5mm Curved Cannulae for the da Vinci Si Surgical System due to potential damage during use and to update labeling instructions.
Aspen Surgical Products is recalling specific sterile drain kits and bulb evacuators because the sterile barrier may be compromised.
Draeger Medical is recalling reusable latex breathing bags and test lungs after a user reported an acute allergic reaction. The product is distributed nationwide.
Intuitive Surgical is recalling 5,217 5mm Curved Cannulae for the da Vinci Si Surgical System because they may become damaged during use.
ErgoSafe Product LLC is recalling Medcare Floor Lifts manufactured between 2010 and 2012 because a design pin may break over time.
Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, potentially exposing patients to infection.
Smiths Medical is recalling HOTLINE Fluid Warming Sets because the injection port septum may leak or become dislodged.
Philips is recalling 19 HeartStart XL+ defibrillators because a therapy board component could malfunction, potentially affecting the device's ability to deliver therapy.
Smiths Medical is recalling HOTLINE Fluid Warming Sets because the injection port septum may leak or become dislodged, potentially causing blood or IV fluid leaks.
DePuy Orthopaedics is recalling 21,675 GLOBAL Anchor Peg Glenoid Plus 2.5mm Breakaway Guide Pins because they may break and be left in patients during surgery.
Breg Inc is recalling two knee support models because they contain latex but lack the required caution label.
Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, potentially exposing patients to contamination.
Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, potentially exposing patients to contamination.
Aspen Surgical Products is recalling sterile wound drainage kits due to a potential compromise of the sterile barrier.
Intuitive Surgical is recalling 5,217 5mm Curved Cannulae for the da Vinci Si Surgical System because they may become damaged during use. The recall also includes labeling updates to guide inspection and handling.
Aspen Surgical Products is recalling wound drainage kits due to a potential compromise of the sterile barrier, posing a risk of infection.
Aspen Surgical Products is recalling sterile bulb evacuators because the sterile barrier may be compromised, potentially increasing infection risk.
Aspen Surgical Products is recalling sterile wound drainage kits due to a potential compromise of the sterile barrier.
Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, potentially exposing patients to infection.
LumiQuick Diagnostics is recalling all lots of the Ketamine Test Card because they were shipped to US locations without required FDA clearance.
LumiQuick Diagnostics is recalling Fentanyl Test Cards because they were shipped to US locations without required FDA approvals.
LumiQuick Diagnostics is recalling Amphetamine Test Cards because they were shipped to locations without required FDA clearances.
LumiQuick Diagnostics is recalling Legionella Test Cards shipped to US locations without approved FDA applications.
LumiQuick Diagnostics Inc. is recalling THC Test Cards shipped to US locations without approved FDA applications.
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