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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.
Alcon is recalling the Constellation Procedure Pak due to reports of patient injury from plastic debris. The debris can result from over-tightening the device with the included plastic wrench.
Covidien's MAHURKAR dialysis catheters are recalled due to excessive lubricant on the catheter tip causing partial or complete obstruction. This risks delaying treatment and may cause blood clots, hemolysis, or embolism.
Covidien recalls 647 MAHURKAR dialysis catheters due to center lumen occlusion caused by excessive silicone lubricant. The blockage may delay treatment or increase risks of blood clots.
Covidien recalls 519 MAHURKAR acute dialysis catheters (Lot 2200400292) due to excessive silicone lubricant coating the catheter tip that may cause partial or full occlusion and treatment delays.
Covidien is recalling MAHURKAR dialysis catheters that may have excessive lubricant coating the catheter tip, potentially causing dangerous blockages that delay treatment or lead to serious complications.
Covidien LP is recalling 3,965 MAHURKAR dialysis catheters due to excessive lubricant causing center lumen occlusion. This may obstruct blood flow or cause hemolysis and blood clots.
Covidien is recalling MAHURKAR dialysis catheters that may have excessive lubricant in the catheter tip, potentially causing obstruction. This could delay treatment or cause serious blood complications including thrombosis or embolism.
Alcon Custom Pak intraocular lens packages are recalled due to reports of patient injury during surgical procedures caused by plastic debris from over-tightening with the included plastic wrench.
Covidien is recalling MAHURKAR Triple Lumen Acute Dialysis Catheters due to excessive lubricant blocking the center lumen, which may delay dialysis and cause blood clots. The recall affects 6,949 units distributed in the US and worldwide.
The MAHURKAR dialysis catheter is recalled because excessive silicone lubricant can obstruct the center lumen, potentially delaying critical dialysis treatment.
Covidien LP is recalling MAHURKAR dialysis catheters due to excess silicone lubricant that can block the central lumen, potentially delaying treatment or causing serious complications.
Covidien's Mahurkar dialysis catheters are recalled due to center lumen occlusion from excessive silicone lubricant, risking treatment delay and serious vascular complications.
Covidien LP recalls MAHURKAR dialysis catheters due to excessive silicone lubricant on the catheter tip, which can obstruct the center lumen. This may delay treatment and cause serious blood complications including embolism and thrombosis.
Covidien LP is recalling MAHURKAR 12 Fr dialysis catheters due to center lumen occlusion from excessive lubricant. The defect may cause treatment delays and serious complications including embolism and thrombosis.
Covidien is recalling 1,875 MAHURKAR dialysis catheters with lot numbers 2204000239 and 2227800110 due to excessive silicone lubricant causing catheter obstruction. The obstruction may delay treatment or cause hemolysis and thrombosis.
Covidien is recalling dialysis catheters with excessive lubricant in the center lumen, which may cause occlusion, obstruct blood flow, and delay treatment.
Alcon is recalling Legion FMS Pak surgical instruments due to reports of patient injuries caused by plastic debris generated from over-tightening with the included plastic wrench.
Covidien is recalling MAHURKAR acute dialysis catheters because the center lumen tip may be occluded by excessive silicone-based lubricant. Obstruction could delay treatment or cause embolism and thrombosis.
Alcon is recalling the Infinity FMS Pak surgical device after reports of patient injuries during procedures caused by plastic debris from over-tightening the included wrench. The recall affects 51,054 units distributed worldwide.
A dialysis catheter product is being recalled due to excessive lubricant coating in the center lumen, which may cause full or partial obstruction. The blockage could delay treatment and increase risk of blood clots and hemolysis.
Covidien LP is recalling 5,373 MAHURKAR dialysis catheters because excessive silicone lubricant can occlude the catheter lumen, potentially causing treatment delays or blood clotting complications.
Olympus HF Resection Electrodes are being recalled due to reports of loop wire breakage when contacting metal objects. Broken fragments can fall inside the patient and require retrieval.
Carefusion 2200 Inc is recalling specific lots of the Snowden-Pencer MIS surgical dissector because the rotation knob may crack or break due to a manufacturing defect.
Carefusion is recalling Snowden-Pencer endoscopic graspers due to potential rotation knob cracking from a manufacturing adhesive defect. Affected lot B23 was distributed in the US and Canada.
Carefusion 2200 Inc is recalling specific lots of the Snowden-Pencer DIAMOND-TOUCH GRASPER endoscopic surgical instrument due to a manufacturing defect that may cause the rotation knob to crack or break, potentially compromising surgical performance.
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