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.
Get Tested International AB is recalling 37 units of its Women's Hormone Test because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 115 units of its Iron Deficiency Test (ferritin) because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 5187 units of its Iron Deficiency Test because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 2 units of its Pregnancy Test because the product was distributed without premarket approval or clearance.
Philips Ultrasound is recalling 4,819 Lumify Diagnostic Ultrasound Systems because compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imaging.
Aizu Olympus is issuing a recall covering 6,578 OER-Elite units to inform customers about pertinent warnings and cautions, recommended maintenance schedules and repair training requirements.
Aizu Olympus is issuing a recall covering 6,578 OER-Mini units to inform customers about pertinent warnings and cautions, recommended maintenance schedules and repair training requirements.
Aizu Olympus is issuing a recall covering 6,578 OER-Pro units to inform customers about pertinent warnings and cautions, recommended maintenance schedules and repair training requirements.
Glycar SA is recalling 30 SJM Pericardial Patches with EnCap Technology because the impacted lot may not meet the required tensile strength specification. The FDA classified it Class I.
Olympus is recalling 7,803 Single Use Ligating Devices because the ligation loop may fail to release or detach, leaving it unintentionally fixed around patient anatomy.
Glycar SA is recalling 18 SJM Pericardial Patches, 5 x 10 cm, because the impacted lot may not meet the required tensile strength specification. The FDA classified it Class I.
Olympus is recalling 7,023 EVIS EXERA III TJF-Q190V duodenovideoscopes after continued reports of positive cultures and infections, and is updating the reprocessing materials.
B. Braun Medical is recalling 9,500 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
B. Braun Medical is recalling 12,200 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
B. Braun Medical is recalling 14,712 anesthesia IV sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
B. Braun Medical is recalling 12,320 burette sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
B. Braun Medical is recalling 12,700 ADDitIV sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
B. Braun Medical is recalling 4,488 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
B. Braun Medical is recalling 25,728 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
B. Braun Medical is recalling 43,452 extension sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
B. Braun Medical is recalling 45,288 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Stryker is recalling 39,148 NICO BrainPath devices because tape used to secure components in the packaging contains latex despite the products being labelled latex-free.
B. Braun Medical is recalling 187,464 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
B. Braun Medical is recalling 40,992 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
B. Braun Medical is recalling 164,568 blood administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
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