Immunotech Estrone RIA Test Kit Recall
Certain lots of Immunotech's Estrone RIA test kit (model DSL8700) may rarely produce falsely high patient results. The risk of injury is very remote and occurs …
Immunotech A.S.
Medical Device recalls
The newest FDA medical device recalls, in plain English. We list the device, the affected model or lot numbers, the FDA classification, and the corrective action the manufacturer is taking.
138 recalls · updated Jul 14, 2026
Da Vinci SP Access Port Kit Recall
Da Vinci SP Access Port Kits (reference numbers 430073 and 430075) may develop cracks in the tray, which could compromise sterility. This is a voluntary recall …
Intuitive Surgical, Inc.
Philips Azurion R3.1 Software Recall
Philips Azurion systems running Software Version R3.1 have two software issues that can cause loss of X-ray imaging, loss of motorized movement, or incorrect …
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Medline Nerve Block Tray 2 Recall
Medline's Nerve Block Tray 2 kits contain MASTISOL Liquid Adhesive vials whose tubing can crack during use, potentially compromising the adhesive delivery. This …
Medline Industries, LP
Medline Surgical Kits Mastisol Recall
Medline medical procedure kits containing Mastisol liquid adhesive are being recalled because the tubing can crack when the adhesive vial is opened, potentially …
Medline Industries, LP
Broviac 4.2 Fr Catheter Cutdown Tray Recall
Bard Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff (Cat 60060) is being recalled due to potential damage to the outer …
Bard Peripheral Vascular Inc
Leksell GammaPlan Software Versions Recall
Leksell GammaPlan software versions 11.3 and 11.4 contain a planning error that could cause radiation treatment to be directed at the wrong location if not …
Elekta, Inc.
Fujirebio Lumipulse pTau 217 Recall
Fujirebio's Lumipulse pTau 217 Plasma Controls (Model 81558) can produce inaccurate test results, potentially causing misclassification of Alzheimer's disease …
Fujirebio Diagnostics, Inc.
Elekta MOSAIQ Oncology System Recall
Elekta's MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO) may deliver radiation treatment twice instead of once in …
Elekta, Inc.
Da Vinci S, Si Cautery Hook Instrument Recall
Intuitive Surgical's da Vinci S and Si Permanent Cautery Hook Instruments (model 420183) may have frayed or broken pitch cables that transmit motion to the …
Intuitive Surgical, Inc.
Philips SmartPath dStream 3.0T MRI Recall
Philips SmartPath to dStream 3.0T MRI systems with software versions R11.1 and R12.1 may display incorrect stiffness values when exporting MR Elastography maps …
Philips North America
RayStation Radiation Therapy Software Recall
RayStation radiation therapy planning software versions 17.0.0, 17.0.1 (RayStation v2025 and v2025 SP1) may fail to recalculate radiation doses correctly when …
RAYSEARCH LABORATORIES AB
RayStation Radiation Therapy Software Recall
RayStation radiation therapy planning software versions 14.0.0, 15.0.0, 15.1.3, and certain 2023B/2024A variants may fail to properly recalculate radiation …
RAYSEARCH LABORATORIES AB
Molift 4-Point Sling Bars Recall
Molift 4-point sling bars can develop a defect where the mounting bolt breaks due to material deformation, potentially preventing the device from working …
ETAC A/S
Beckman Coulter DxH Diluent Recall
Certain lots of Beckman Coulter DxH Diluent products can cause elevated platelet counts in daily quality checks on blood cell counting systems. This may lead to …
Beckman Coulter, Inc.
AlignRT InBore Laser Documentation Recall
The AlignRT InBore system, used in medical imaging, contains six lasers that help track patient position. The manufacturer failed to provide required safety …
Vision RT Ltd
Penner Pacific Bathing Spa Recall
Penner Pacific Bathing Spa Model 360020-1P is being recalled because it lacks a unique device identifier required by regulation. This is a labeling and tracking …
Penner Patient Care, Inc.
Philips Azurion 3M15 Recall
Philips Azurion 3M15 imaging systems may display a dark, unusable image during Roadmap Pro procedures if the footswitch pedal is lightly tapped before a scan. …
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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