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.
Smith & Nephew is recalling TWINFIX Ultra HA 4.5 mm Suture Anchors because pinholes in primary pouches may breach the sterile barrier.
Ebi, LLC is recalling 427 units of the Cypher MIS Screw System because several complaints reported screw head splay.
Instrumentation Laboratory is recalling 486 ACL TOP CTS analyzers because a potential carryover issue may cause shortened APTT clotting times.
Smith & Nephew is recalling Bioraptor 2.9 mm Suture Anchors because pinholes in primary pouches may breach the sterile barrier.
Churchill Medical Systems is recalling 3,040 Central Dressing Change Kits because microbore tubing may disconnect from male luers on the extension sets.
Smith & Nephew is recalling OSTEORAPTOR 2.3 mm suture anchors because pinholes in primary pouches may breach the sterile barrier.
Smith & Nephew is recalling 1,643 TWINFIX Ultra suture anchors because pinholes in primary pouches may breach the sterile barrier.
Philips is recalling Brilliance CT scanners because the footswitch cover may impinge on the footswitch, causing the patient support to move unexpectedly.
Smith & Nephew is recalling TWINFIX Ultra 5.5 mm PLLA-HA Suture Anchors because pinholes in primary pouches may breach the sterile barrier.
Instrumentation Laboratory is recalling 185 ACL TOP 700 CTS analyzers due to a potential carryover issue that may cause shortened APTT clotting times.
Smith & Nephew is recalling TWINFIX Ultra suture anchors because pinholes in primary pouches may breach the sterile barrier, posing a risk of infection.
Smith & Nephew is recalling TWINFIX Ultra suture anchors because pinholes in primary pouches may breach the sterile barrier.
Rauland-Borg is recalling Responder 5 nurse call systems because counterfeit electronic components may cause the devices to lose communication functionality.
Smith & Nephew is recalling BIORAPTOR 2.9 mm Suture Anchors because pinholes in primary pouches may breach the sterile barrier.
Synthes USA is recalling one unit of a Cannulated Distal Femoral Nail because it was distributed despite being within the scope of a previous recall.
Smith & Nephew is recalling Bioraptor 2.9 mm Suture Anchors because pinholes in primary pouches may breach the sterile barrier.
Smith & Nephew is recalling TWINFIX Ultra HA 5.5 mm Suture Anchors because pinholes in primary pouches may breach the sterile barrier.
Smith & Nephew is recalling 1,735 Bioraptor 2.9 mm suture anchors because pinholes in the primary pouches may breach the sterile barrier.
Instrumentation Laboratory is recalling 311 ACL TOP 700 analyzers due to a potential carryover issue that may cause shortened APTT clotting times.
Smith & Nephew is recalling TWINFIX Ultra suture anchors because pinholes in primary pouches may breach the sterile barrier.
Tornier is voluntarily recalling Aequalis Reversed II and Fracture Impactors because the tip may separate during surgery.
Smith & Nephew is recalling OSTEORAPTOR 2.9 mm Suture Anchors because pinholes in primary pouches may breach the sterile barrier.
Smith & Nephew is recalling OSTEORAPTOR 2.9 mm Suture Anchors because pinholes in primary pouches may breach the sterile barrier.
Smith & Nephew is recalling 708 TWINFIX Ultra HA suture anchors because pinholes in primary pouches may breach the sterile barrier.
Smith & Nephew is recalling TWINFIX Ultra HA 4.5 mm Suture Anchors because pinholes in primary pouches may breach the sterile barrier.
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