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FDA recalls of medical devices including diagnostics, implants, and consumer health hardware.
Philips Azurion 7 B20 fluoroscopy systems may move unexpectedly when the Reset Geometry button is pressed, even with the table lock engaged, creating a potential safety risk during medical procedures.
Medline Industries is recalling Intubation Trays (SKU DYNJAA245B) distributed nationwide and in Canada because smaller 8 Fr suction catheters were packed instead of required 14 Fr catheters, which may cause airway obstruction and respiratory failure.
Laerdal Medical Corporation recalled certain Compact Suction Unit 4 RTCA models because units made during a limited period may emit electromagnetic noise exceeding established RTCA standards.
Medline Industries is recalling 216 medical convenience kits containing BD ChloraPrep Triple Swabsticks due to potential open seals on applicator packaging that may compromise product sterility.
Leksell GammaPlan software versions 11.3 and 11.4 contain an error in stereotactic reference definition that may cause treatment plans to irradiate incorrect patient locations if the error goes undetected.
Medline Industries is recalling 1,350 Adult Cath Securement Dressing Kits with potentially open seals on BD ChloraPrep Triple Swabstick applicators. Open packaging may compromise product sterility.
Medline Industries is recalling 4,300 Blood Culture Kits due to open seals on applicator packaging that could compromise sterility and introduce contamination during specimen collection.
Medline is recalling specific circumcision kits due to potentially open seals on sterile applicators that could compromise sterility. This affects 168 units distributed nationwide.
Philips has recalled the Spectral CT 7500 medical imaging device due to fasteners that may not be torqued to specification, potentially allowing rotor parts to become unsecured or displaced. No injuries have been reported.
Philips Brilliance iCT CT scanners are recalled because fasteners securing the rotor may not be properly tightened. If multiple fasteners are loose, rotor parts could become unsecured or displaced.
Medline 14 Fr Suction Catheter Kits may contain an 8 Fr catheter instead, potentially causing airway obstruction and respiratory failure. The kits were distributed nationwide and in Canada.
Philips is recalling 283 Spectral CT scanners because fasteners that attach the rotor to the gantry bearing may not be properly torqued, potentially allowing rotor parts to become loose or displaced during operation.
Philips is recalling the Azurion 3 M15 imaging system because the patient table may move unexpectedly when the Reset Geometry button is pressed, even when locked. This poses a patient safety hazard during interventional procedures.
Philips is recalling 52 IQon Spectral CT scanners because fasteners attaching the rotor may not be properly torqued, potentially allowing rotor parts to become displaced or expelled during operation.
A firmware defect in the da Vinci 5 Surgeon Console Viewer Display may cause loss of one or both displays during surgery. When visualization is lost, surgical instruments remain active, risking tissue injury and bleeding.
Surepulse Medical is recalling the VS Cap Large, a component of the VS Newborn Heart Rate Monitor, due to incorrect sizing information in the labeling.
Surepulse Medical recalls VS Cap Small components of newborn heart rate monitors due to incorrect sizing guidance in the labeling. The labeling error could affect proper device fit.
Medline Industries is recalling 2,448 suture removal kits due to potentially open packaging seals on BD ChloraPrep Triple Swabsticks applicators, which could compromise sterility.
The Surepulse VS Cap Extra Large component of newborn heart rate monitors has been recalled because the product labeling contains an incorrect sizing guide.
Medline Industries is recalling 7,570 medical convenience kits containing BD ChloraPrep Triple Swabsticks due to potentially open seals on applicator packaging. The kits are distributed nationwide to hospital and clinical settings.
Straumann USA is recalling 561 units of WB Impression Post Closed Tray due to incorrect impression caps in packaging. The caps are magenta instead of the intended brown color.
Surepulse Medical recalled the VS Cap Extra Small component of its newborn heart rate monitor due to an incorrect sizing guide in the product labeling.
Surepulse Medical is recalling certain newborn heart rate monitor caps due to incorrect sizing information in the labeling. The issue affects specific lot numbers distributed in the US and internationally.
Boston Scientific is recalling the AXIOS Stent and Electrocautery-Enhanced Delivery System (20mm x 10mm) due to reports of stent deployment and expansion failures that may require additional surgical or endoscopic intervention.
Boston Scientific is recalling AXIOS stents due to reported deployment and expansion issues. The devices may fail to expand properly during procedures, potentially requiring additional surgical intervention.
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