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.
Maquet Cardiovascular is recalling Adult ECC Packs because a design feature may prevent sterilization gas from reaching all fluid paths, potentially compromising sterility.
Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design feature may prevent sterilization gas from reaching all fluid paths.
Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design flaw may prevent proper sterilization of the stopcock ports.
Maquet Cardiovascular is recalling specific ECC tubing sets because a design feature may prevent proper sterilization, potentially compromising sterility.
Maquet Cardiovascular is recalling specific batches of Getinge-BEQ-TOP 38900 ECC Packs because a design flaw may prevent proper sterilization of the stopcock ports.
Maquet Cardiovascular is recalling specific batches of Maquet Getinge-BEQ-TOP 15704 Circulatory Circuits because a design feature may prevent proper sterilization of the stopcock ports.
Terumo Medical Corporation is recalling Portico Solo Re-Collapsible Access Systems because the tip may dislodge from the sheath, potentially causing injury.
Terumo Medical Corporation is recalling 1,431 SOLOPATH Re-Collapsible Access Systems because the tip may dislodge from the sheath, potentially compromising the device's smooth transition.
Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization gas flow, compromising sterility.
Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design flaw may prevent sterilization gas from reaching all parts of the device.
Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.
Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design flaw may prevent proper sterilization, potentially compromising sterility.
Maquet Cardiovascular is recalling specific Custom Tubing Sets for Extracorporeal Circulation because a design feature may prevent proper sterilization, potentially compromising sterility.
Abbott Vascular is recalling the MitraClip XTR Clip Delivery System because clips may open or become nonfunctional during implantation, requiring additional surgery.
Terumo Medical Corporation is recalling 2,228 SoloPath Balloon Expandable TransFemoral Systems because the device tip may dislodge from the sheath, potentially causing vessel trauma.
Maquet Cardiovascular is recalling specific Pressure Pigtail devices because a design feature may prevent sterilization gas from reaching all fluid paths, potentially compromising sterility.
Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design flaw may prevent proper sterilization, potentially compromising sterility.
Maquet Cardiovascular is recalling NICU ECC Packs because a design feature may prevent sterilization gas from reaching all fluid paths, compromising sterility.
Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design flaw may prevent proper sterilization, potentially compromising sterility.
Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design flaw may prevent proper sterilization, potentially compromising sterility.
Maquet Cardiovascular is recalling specific Custom Tubing Sets for Extracorporeal Circulation because the design may prevent proper sterilization gas flow, compromising sterility.
Maquet Cardiovascular is recalling specific ECC Pump Packs because a design feature may prevent proper sterilization, potentially compromising sterility.
Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.
Maquet Cardiovascular is recalling Rapid Response Universal Packs because a design flaw may prevent proper sterilization of the stopcock ports.
Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design flaw may prevent sterilization gas from reaching all parts of the device.
Looking for a different category? Browse all recalls.