Category
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 MicroClave Clear Neutral Connectors used in intravascular catheters due to a manufacturing defect that creates a visible gap between housing parts.
Cook Incorporated is recalling 5,400 Roadrunner UniGlide Hydrophilic Wire Guides because the devices failed packaging tests required to verify sterility. The affected devices are used in diagnostic and interventional vascular procedures.
Alcor Scientific is recalling iSED Primary Pump Tubing Spare Part Kits due to potential biohazard leak from the Probe Tube when installed on the iSED ESR Analyzer. Affected lot (4/22) includes 38 units distributed nationwide and internationally.
ICU Medical recalls 5.8 million infusion extension sets due to a manufacturing defect that creates a visible gap in the connector housing, potentially compromising device integrity.
Cook Incorporated is recalling 1,450 units of Roadrunner PC Hydrophilic Wire Guide devices due to failed sterility packaging testing. The devices may not meet sterility requirements for safe use in vascular procedures.
Exactech GXL acetabular hip implant liners in non-conforming bags may experience accelerated wear. Approximately 7,946 devices were distributed worldwide. No injuries have been reported.
ICU Medical is recalling bifurcated extension sets used in medical infusions. The sets have a manufacturing defect causing visible gaps in the connector housing, affecting millions of units distributed in the U.S. and internationally.
Philips Pinnacle3 radiation therapy planning systems may export incorrect dose information when multiple beams are used with certain Edit Prescription settings. 169 systems are affected.
Cook Incorporated is recalling Roadrunner UniGlide Hydrophilic Wire Guides (Lot 14156569) because packaging testing failed, indicating the device's sterility may be compromised. The recall affects 75 units distributed in the U.S. and internationally.
Cook Incorporated is recalling 585 Roadrunner UniGlide Hydrophilic Wire Guides because they failed packaging sterility tests, potentially compromising device sterility.
Surpria software versions V3.11 and V3.22 may encounter processing errors that prevent image reconstruction, potentially requiring additional scans and exposing patients to unnecessary radiation.
A laboratory automation device's setup screen indicates minimal volume when the exact volume should be loaded, potentially causing over-diluted, under-diluted, or improperly prepared samples and false test results.
Cook Incorporated is recalling 2,407 units of Roadrunner PC Hydrophilic Wire Guide due to failed packaging integrity testing that may compromise device sterility. No illnesses or injuries have been reported.
Exactech is recalling certain GXL acetabular hip implant liners because non-conforming packaging may cause accelerated wear. No injuries have been reported.
Exactech is recalling specific GXL acetabular hip implant liners due to non-conforming packaging that may cause accelerated device wear. The recall affects 1,017 devices distributed worldwide.
Cook Incorporated is recalling the Roadrunner UniGlide Hydrophilic Wire Guide due to failed packaging sterility testing. The device's sterility may be compromised.
The INOmax DSIR nitric oxide delivery system is incompatible with the 2021-upgraded Leoni Plus ventilator. Without proper connection including a required one-way valve, patients may receive excessive nitric oxide.
ICU Medical is recalling approximately 5.8 million MicroClave Clear Connectors used in IV administration due to a manufacturing defect that creates a visible gap between the connector housing.
Isopure Corp recalls its ACDS (Acidified Concentrate Distribution and Storage) system used in hemodialysis facilities due to a potential electrical safety hazard that may result in electric shock or arcing.
Exactech is recalling 136 GXL acetabular liners used in hip implants due to non-conforming packaging that may cause accelerated wear. The devices were distributed worldwide to multiple countries.
ICU Medical is recalling intravascular administration set connectors due to a manufacturing defect that creates a visible gap in the connector housing. The defect affects approximately 5.8 million units distributed nationwide and internationally.
Surpria 64 CT scanner software versions V3.11 and V3.22 may encounter errors that prevent image reconstruction, requiring repeat scans that expose patients to additional radiation. 16 units nationwide are affected.
Cook Incorporated is recalling Roadrunner UniGlide Hydrophilic Wire Guides due to packaging testing failures that may compromise device sterility. The recall affects 865 units distributed nationwide and internationally.
Technomed Europe is recalling disposable subdermal needle electrodes because patients may suffer burns if electrodes are left in place during MRI scanning. The manufacturer failed to provide adequate safety information in the device instructions.
Steris Corporation is recalling 619 boxes of Verify SixCess Challenge Pack due to incorrect chemical indicators in the packaging. This sterilization validation device is distributed across 31 U.S. states.
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