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.
Teleflex Medical is recalling 4,312 units of RUSCH LASERTUBE (Rubber) because the laser guard foil partially separated or detached at the edges.
Maquet Cardiovascular is recalling specific adult extracorporeal circulation tubing sets because a design feature may prevent proper sterilization, potentially compromising sterility.
Maquet Cardiovascular is recalling specific Cardioplegia Packs because a design feature may prevent sterilization gas from reaching all parts of the device.
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 Sash & Accessory Packs because a design flaw may prevent proper sterilization of stopcock ports.
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 the design may prevent sterilization gas from reaching all fluid paths.
Maquet Cardiovascular is recalling specific neonatal tubing sets because a design feature may prevent sterilization gas from reaching all parts, potentially compromising sterility.
Maquet Cardiovascular is recalling specific pediatric extracorporeal circulation tubing sets because the stopcock design may prevent proper sterilization, potentially compromising sterility.
Maquet Cardiovascular is recalling specific AV Manifold units for extracorporeal circulation because a design flaw may prevent proper sterilization of the stopcock ports.
Maquet Cardiovascular is recalling specific batches of ECC tubing sets 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 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 of stopcock ports.
Maquet Cardiovascular is recalling specific ECC tubing sets because a design flaw may prevent proper sterilization, potentially compromising sterility.
Maquet Cardiovascular is recalling specific AV Loop tubing sets because a design feature may prevent proper sterilization, potentially compromising sterility.
Maquet Cardiovascular is recalling Custom Tubing Sets for Extracorporeal Circulation because the stopcock design may prevent sterilization gas from reaching the fluid path, compromising sterility.
Maquet Cardiovascular is recalling specific ECC tubing sets because a design feature may prevent proper sterilization, potentially compromising sterility.
Maquet Cardiovascular is recalling Rotaflow Packs because a design feature may prevent proper sterilization, potentially compromising sterility.
Maquet Cardiovascular is recalling specific tubing packs for extracorporeal circulation because a design feature may prevent sterilization gas from reaching all fluid paths, potentially compromising sterility.
Maquet Cardiovascular is recalling specific Open Heart Packs because a design feature may prevent sterilization gas from reaching all parts, potentially compromising sterility.
Maquet Cardiovascular is recalling specific batches of adult extracorporeal circulation tubing sets because a design feature may prevent proper sterilization gas flow.
Maquet Cardiovascular is recalling specific tubing packs used for extracorporeal circulation because a design feature may prevent proper sterilization gas flow, 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 a design feature may prevent proper sterilization, potentially compromising sterility.
Maquet Cardiovascular is recalling specific ECC tubing sets because a design feature may prevent proper sterilization, potentially compromising sterility.
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