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 5 units of its Chlamydia Test because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 128 units of its Ovulation Test (5 tests) because the product was distributed without premarket approval or clearance.
Philips North America is recalling 6 CT 5300 systems because a tube heat exchanger whose screws are not tightened after replacement may detach and damage other components.
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-Pro 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.
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.
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 7,023 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 30,250 extension sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
B. Braun Medical is recalling 4,536 units iv administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
B. Braun Medical is recalling 63,192 units iv administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
B. Braun Medical is recalling 88,200 anesthesia IV sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
B. Braun Medical is recalling 10,896 units iv administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
B. Braun Medical is recalling 12,168 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
B. Braun Medical is recalling 5,952 units iv administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
B. Braun Medical is recalling 23,650 extension sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
B. Braun Medical is recalling 24,072 units iv administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
B. Braun Medical is recalling 37,656 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
B. Braun Medical is recalling 31,392 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
B. Braun Medical is recalling 2,871,707 units caresite sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
B. Braun Medical is recalling 29,900 units iv administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
B. Braun Medical is recalling 13,128 extension sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
B. Braun Medical is recalling 40,008 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
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