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 specific batches of ECC Packs 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 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 gas flow.
NeuroLogica is recalling 288 Samsung GM85 Mobile Digital X-ray Imaging Systems due to a potential safety latch issue that could cause the arm to fall.
Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization.
Maquet Cardiovascular is recalling specific Children's Large ECC 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 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 batches of Getinge-BEQ-T 8803#Circ Circuit Small Patient tubing sets because the sterilization process may not ensure sterility in the stopcock ports.
Maquet Cardiovascular is recalling specific batches of custom tubing sets for extracorporeal circulation because the design may prevent proper sterilization gas flow.
Maquet Cardiovascular is recalling specific Custom Tubing Sets for Extracorporeal Circulation because the stopcock design may prevent proper sterilization, potentially compromising sterility.
Maquet Cardiovascular is recalling specific ECC tubing sets 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 configuration 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 pediatric extracorporeal circulation tubing sets because a design flaw may prevent proper sterilization of stopcock ports.
Maquet Cardiovascular is recalling specific tubing packs for extracorporeal circulation because the design may prevent proper sterilization gas flow, 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 Pediatric CPB 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 the design may prevent proper sterilization gas flow, potentially compromising sterility.
Maquet Cardiovascular is recalling specific batches of Getinge-BO-T 52360 Cardioplegia Packs because a design feature may prevent proper sterilization of the stopcock ports.
Maquet Cardiovascular is recalling specific LVAD tubing sets because a design feature may prevent sterilization gas from reaching all parts, compromising sterility.
Maquet Cardiovascular is recalling specific 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 the design may prevent proper sterilization gas flow, compromising sterility.
Maquet Cardiovascular is recalling specific LVAD tubing sets because a design feature may prevent proper sterilization, potentially compromising sterility.
Looking for a different category? Browse all recalls.