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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.
ICU Medical is recalling 900 units of Appx 1.7 ml Bag Spike w/Integrated Clave due to a molding defect that may cause leaks in male luers.
ICU Medical is recalling specific infusion components due to a molding defect that may cause leaks, risking fluid contamination or exposure to hazardous medications.
GA Health Company Limited is recalling ScopeValet Guardian Disposable Endoscope Valves because the suction button may be sticky or broken, potentially prolonging procedures.
ICU Medical is recalling specific Spinning Spiros components due to a molding defect that may cause leaks, risking fluid path contamination or exposure to hazardous medications.
GA Health Company Limited is recalling 11,000 Stopcon Disposable Endoscope Valve Sets because the suction button may be sticky or broken, potentially prolonging medical procedures.
Beckman Coulter is recalling MicroScan Pos MIC Panel Type 34 because a portion of the lot failed quality control, potentially causing false elevated daptomycin results.
Boston Scientific is recalling 215 IcePearl 2.1 CX Prostate Cryoablation Kits nationwide due to a complaint trend regarding needle shaft gas leaks.
ICU Medical is recalling specific syringes and administration sets with spinning Spiros components due to a molding defect that may cause fluid leaks.
Boston Scientific is recalling 39 IceSphere 1.5 Cryoablation Needles nationwide due to a complaint trend regarding needle shaft gas leaks.
Boston Scientific is recalling 93 units of IceRod 1.5 90° Cryoablation Needles nationwide due to a complaint trend regarding needle shaft gas leaks.
Boston Scientific is recalling 115 IceRod He-Thaw Prostate Cryoablation Kits nationwide due to a complaint trend regarding needle shaft gas leaks.
B Braun Medical is recalling 16 APEX Compounding System Control Panel Modules because they may fail to detect air bubbles, potentially compromising drug accuracy.
B Braun Medical is recalling 85 APEX Compounding System Control Panel Modules because they may fail to detect air bubbles, potentially resulting in inaccurate drug compounding.
Boston Scientific is recalling 245 units of IceSphere 1.5 Cryoablation Needles nationwide due to a complaint trend regarding needle shaft gas leaks.
Boston Scientific is recalling 3,894 IceRod 1.5 MRI 90° Cryoablation Needles nationwide due to a complaint trend regarding needle shaft gas leaks.
ICU Medical is recalling Spiros closed male luer devices due to a molding defect that may cause leaks. The defect could lead to infusion delays, fluid contamination, or exposure to hazardous medications.
Boston Scientific is recalling 627 IceSeed 1.5 MRI Cryoablation Needles nationwide due to a complaint trend regarding needle shaft gas leaks.
GE Healthcare is recalling three Revolution CT systems due to a potential for unintended patient orientation or scan settings when using Intelligent Protocoling.
ICU Medical is recalling specific Spiros and Clave IV administration sets due to a molding defect that may cause leaks in spinning male luer components.
GA Health Company Limited is recalling 25,000 units of STOPCON Disposable Valves because the suction button may be sticky or broken, potentially prolonging procedures.
GA Health Company Limited is recalling 93,700 units of Andorate Disposable Endoscope Valves because the suction button may be sticky or broken, potentially prolonging medical procedures.
Baxter Healthcare is recalling 9,353 SIGMA Spectrum Infusion Pumps due to a potential software error during programming.
Boston Scientific is recalling 419 Five IceSphere Prostate Cryoablation Kits nationwide due to a complaint trend regarding needle shaft gas leaks.
Baxter Healthcare is recalling 140,006 SIGMA Spectrum Infusion Pumps due to a potential software error during programming.
Boston Scientific is recalling 772 IceRod 1.5 MRI Cryoablation Needles nationwide due to a complaint trend regarding needle shaft gas leaks.
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