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.
Wright Medical Technology is recalling 92 units of the Crosscheck Plating system because dimensional specifications are out of range, posing a risk of intraoperative malfunction.
Churchill Medical Systems is recalling 5,200 6-inch trifurcated extension sets due to a potential leak caused by insufficient bonding between the needleless device and female luer.
Hospira is recalling 38,882 LifeCare PCA infusion systems because the clear plastic door design allows excessive flexing, permitting unauthorized access to medication vials.
Churchill Medical Systems is recalling 1,050 bifurcated sets with check valves and Bionectors due to a potential for leaking caused by insufficient bonding.
Wright Medical Technology is recalling 51 units of the Crosscheck Plating System because dimensional specifications are out of range, posing a risk of intraoperative malfunction.
Churchill Medical Systems is recalling 100 Bifurcated Extension Sets because a defect may cause leaking. The sets are used to administer medical fluids.
Del Mar Reynolds Medical is recalling Spacelabs Pediatric Flow Sensor Kits because they report inspiratory and expiratory tidal volumes lower than the actual volumes delivered to patients.
Thermedx LLC is recalling 127 Fluid Management System P4000 units due to software bugs that could affect the accuracy of fluid deficit measurements.
Wright Medical Technology is recalling 172 units of the Crosscheck Plating System because specific dimensions are out of specification, posing a risk of intraoperative malfunction.
Churchill Medical Systems is recalling 2,350 units of 4-inch Microbore Double Lumen Sets due to a potential leak caused by an insufficient bond between the needleless device and the female luer.
Wright Medical Technology is recalling 52 units of the Crosscheck Plating System because dimensional specifications are out of range, posing a risk of intraoperative malfunction.
Churchill Medical Systems is recalling 129,500 units of 7-inch High Pressure Sets with Bionector due to a potential for leaking caused by insufficient bonding.
Wright Medical Technology is recalling 102 units of the Crosscheck Plating System because dimensional specifications are out of tolerance, posing a risk of intraoperative malfunction.
Wright Medical Technology is recalling 151 units of the Crosscheck Plating System because dimensional specifications are out of tolerance, posing a risk of intraoperative malfunction.
Musculoskeletal Transplant Foundation is recalling 25 units of DBX Mix bone void filler because the outer packaging seal may not be fully intact.
Specialty Appliance Works is recalling Universal Nuts used in Herbst Appliances because they were made with 416 SS instead of the specified 303 SS.
Exactech, Inc. is recalling 112 Equinoxe 44mm Short Humeral Head shoulder implant components because incorrect outer and inner labeling may misidentify the device size.
SenTec AG is voluntarily replacing V-Sign Sensor 2 units because a part of the PCO2 measuring unit deteriorates prematurely, disabling PCO2 monitoring. The recall affects 129 units in the US and 59 outside the US.
Focus Diagnostics is recalling 300 units of the Stratify JCV DxSelect assay (Lot 27333) because a non-conforming batch may cause false positive results.
PhotoMedex, Inc. is recalling Iamin Moist Dressings and Hydrating Gel because their labeling does not match the intended uses approved by the FDA.
Specialty Appliance Works is recalling 14,428 Universal Nuts used in orthodontic Herbst Appliances because they were manufactured with 416 SS instead of the specified 303 SS.
X Spine Systems Inc is recalling 14 units of Xpress System Pedicle Screw Assemblies because the laser marking on the yoke incorrectly states 7.5 x 55mm instead of 5.5 x 55mm.
Specialty Appliance Works is recalling Universal Nut components for Herbst Appliances because they were made with 416 SS instead of the specified 303 SS.
Biomet Spine is recalling 874 Torque Limiting Handles used in spinal fixation due to supplier component updates.
Specialty Appliance Works is recalling Universal Nuts for MiniScope Mechanical Sets because they were made with 416 stainless steel instead of the specified 303 stainless steel.
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