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.
FDA is recalling 3,113,280 units of the EGIA 60 Articulating Medical Stapler due to missing pin components that may cause incomplete staple formation and serious surgical complications.
Covidien LLC is recalling Signia Tri-Staple 2.0 reloads because missing pin components may cause incomplete staple formation, potentially leading to serious surgical complications.
Teleflex Medical is voluntarily recalling specific lots of Hudson RCI Sheridan tracheal tubes because the 15 mm connector may disconnect from the tube.
Covidien LLC is recalling Signia Tri-Staple 2.0 reloads because missing pin components may cause incomplete staple formation, leading to serious surgical complications.
The FDA is recalling 3,113,280 units of the EGIA 60 Articulating Extra Thick Sulu device due to a missing pin component that may cause incomplete staple formation and serious surgical complications.
FDA is recalling 3.1 million EGIA 45 staplers due to missing pins that may cause incomplete stapling and serious surgical complications.
The FDA is recalling Signia Tri-Staple 2.0 devices because missing pin components may cause incomplete staple formation, leading to serious surgical complications.
Covidien LLC is recalling Signia Tri-Staple 2.0 devices because missing pin components may cause incomplete staple formation, potentially leading to serious surgical complications.
The FDA is recalling 3,113,280 units of the EGIA 30 Articulating Medical device due to missing pin components that may cause incomplete staple formation and serious surgical complications.
The FDA is recalling 3,113,280 units of EGIA45 CT AR MD THK REL surgical staplers because missing pin components may cause incomplete staple formation, leading to serious surgical complications.
Teleflex Medical is voluntarily recalling specific lots of Sheridan/CF Novaplus 7.0 mm tracheal tubes because the 15 mm Sheridan connector may disconnect from the tube.
The FDA is recalling Signia Tri-Staple 2.0 devices because missing pin components may cause incomplete staple formation, leading to serious surgical complications.
Ethicon, Inc. is recalling specific lots of ETHIBOND EXCEL polyester sutures because raw materials may contain high endotoxin levels.
The FDA is recalling 3,113,280 units of the EGIA 45 Articulating Xtra Thick Sulu device due to a missing pin component that may cause incomplete staple formation and serious medical complications.
GE Healthcare is recalling 1,113 Discovery IQ PET/CT systems because the table may stop moving while X-ray exposure continues.
Teleflex Medical is voluntarily recalling specific lots of Hudson RCI Sheridan tracheal tubes because the 15 mm connector may disconnect from the endotracheal tube.
Cook Inc. is recalling 73 Advance Enforcer 35 Focal Force PTA Balloon Catheters because they may burst below the rated pressure, posing risks of vessel injury and balloon fragmentation.
Teleflex Medical is voluntarily recalling specific lots of Hudson RCI Sheridan tracheal tubes because the 15 mm Sheridan connector may become disconnected from the endotracheal tube.
Teleflex Medical is voluntarily recalling specific lots of Hudson RCI Sheridan EZ-ENDO endotracheal tubes because the 15 mm Sheridan connector may disconnect from the tube.
Cook Inc. is recalling 34 Advance Enforcer 35 Focal Force PTA Balloon Catheters because they may burst below the rated pressure, posing risks of vessel injury and balloon fragmentation.
FDA is recalling 3,113,280 units of the EGIA 60 Curved Tip Art Med Thick Sulu surgical stapler because missing pin components may cause incomplete staple formation and serious medical complications.
GE Healthcare is recalling 1,113 Optima PET/CT 560 and 560FX systems because the table may stop moving while X-ray exposure continues.
Teleflex Medical is voluntarily recalling specific lots of Hudson RCI Sheridan tracheal tubes because the 15 mm connector may disconnect from the endotracheal tube.
GE Healthcare is recalling 1,113 Discovery PET/CT 710 systems because the table may stop moving without stopping X-ray exposure.
Stryker GmbH is recalling 447 Endotrac ECTR Hook/Triangle Blade Kits because the sterile bag seal may be compromised, potentially affecting sterility.
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