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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.
Cardinal Health Beta-Hydroxybutyrate diagnostic reagent has been recalled due to stability deterioration causing out-of-range quality control values. No illnesses have been reported.
Tenderneeds Fertility LLC recalls its Deluxe At-Home ICI Insemination Kit (SKU 636391205856), all lots sold before December 9, 2019, due to distribution without FDA marketing authorization.
Stanbio Laboratory is recalling Cardinal Health Beta-Hydroxybutyrate in vitro diagnostic reagents due to reagent instability causing out-of-range quality control values that may affect diagnostic accuracy.
Baxter's user guide for the Amia Automated PD System incorrectly describes how the Ultrafiltration Limit setting controls the Extra Last Drain Mode. This documentation error could affect patients' ability to properly end therapy sessions.
Verathon recalls GlideScope Go Monitors due to failure to meet IP67 waterproof rating, which may allow fluid ingress and loss of functionality.
Stanbio Laboratory is recalling Beta-Hydroxybutyrate LiquiColor diagnostic reagent due to reagent deterioration that causes lower than expected or out-of-range quality control values, affecting test accuracy.
Stanbio Laboratory recalled Beta-Hydroxybutyrate Reagent A due to deterioration in reagent stability. The degradation resulted in out-of-range Quality Control values that could affect diagnostic accuracy.
ROi CPS LLC is updating instructions for the Regard NEWBORN KIT infant heel warmer (688 units in Missouri) to include a warning: activate away from the face, infant, and others.
Tenderneeds Fertility LLC is recalling the Premium Human IUI Kit and Metal Speculum because it was distributed without required FDA marketing authorization. All products sold before December 9, 2019 are affected.
Sunrise Medical recalls Zippie Voyage early intervention strollers because the seating system may unexpectedly detach and fall, causing injury. Approximately 9,865 devices are affected.
Sunrise Medical is recalling the Zippie Voyage early intervention stroller due to unexpected seating system detachment that can cause falls and injury. Approximately 4,741 devices are affected worldwide.
Eight Medical International BV is recalling the Recirculator 8.0s Disposable Lavage Kit due to potential aluminum ion release during warming therapy that may expose patients under certain use conditions.
RayStation versions 9A through 11A may set initial delivery positions incorrectly during setup beam localization. Five units are affected; no patient injuries reported.
Coaxial Interventional Needles from INNOVATIVE TOMOGRAPHY PRODUCT GMBH may not be properly sterilized. Multiple lot numbers are affected and should not be used.
Cytocell Ltd. is recalling CytoCell DiGeorge/VCFS genetic probes that may display unexpected chromosome signals, potentially causing misdiagnosis. Affected reagents were distributed to laboratories in multiple US states and Canada.
The Proteus 235-Proton Therapy System may deliver proton therapy without prescribed beam gating if the user forgets to select the trigger input. This could cause radiation to be positioned incorrectly.
CooperVision's AQUATECH PLUS 1 DAY TORIC contact lenses (lot R0121629) have misaligned axis marks that may cause blurred vision in patients.
CooperVision is recalling CLARITI 1 DAY TORIC daily disposable contact lenses due to misaligned axis marks that can cause blurred vision. Affected lenses in lot U0108833 were distributed in seven US states and internationally.
The latch mechanism on the Lift-Off foot section of certain Affinity Four Birthing Beds may be damaged, potentially causing improper engagement and creating a fall risk for patients. Hill-Rom is recalling approximately 1,096 affected beds.
CooperVision is recalling SPECSAVERS UMERE TORIC daily disposable contact lenses with UV blocker due to a manufacturing defect in which misaligned axis marks may cause blurred vision.
GE OEC Medical Systems is recalling certain OEC 3D Imaging fluoroscopic X-ray systems due to potential premature depletion of the coin cell battery used to monitor X-ray tube temperature, which could cause the system to become inoperable.
Maquet Medical Systems USA is recalling 33 Heater Cooler Unit (HCU 30) devices due to potential water contamination in device circuits that could introduce Mycobacteria or other bacteria. The devices were distributed to nine U.S. states.
Merit Medical Systems is recalling basixALPHA Inflation Devices due to a design flaw where the syringe handle can separate when withdrawn, affecting device functionality.
CooperVision is recalling CLARITI 1 DAY TORIC contact lenses (Lot W0106167) due to misaligned axis marks that may cause blurred vision. The recall affects 450 lenses distributed across select U.S. states and multiple countries.
GE Healthcare's CARESCAPE PDM-Masimo SpO2 physiological monitor displays can freeze after extended use without power down, preventing real-time oxygen saturation monitoring.
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