Medline Cardiac Surgery Kits Recall
Medline has recalled multiple surgical convenience kits used in cardiac procedures due to sterilization equipment calibration issues that may compromise the …
Medline Industries, LP
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.
125 recalls · updated Jun 11, 2026
Olympus Sphincterotome V Device Recall
Olympus Single Use 3-Lumen Sphincterotome V devices may deform and lose performance if they were not properly thermoformed during manufacturing. These …
Olympus Corporation of the Americas
Olympus Sphincterotome V Recall
Olympus has recalled certain Single Use 3-Lumen Sphincterotome V instruments because some units may not have been properly heat-formed, causing them to deform …
Olympus Corporation of the Americas
Olympus Sphincterotome Recall KD-401Q
Olympus Disposable Triple Lumen Sphincterotome Model KD-401Q-0330 may deform and lose performance if it was not properly thermoformed during manufacturing. This …
Olympus Corporation of the Americas
Medline Convenience Kits Recall
Medline Convenience Kits (Model DYNJ50806L) have been recalled because sterilization equipment calibration problems may have compromised the sterility of these …
Medline Industries, LP
Medline PPE Kit Model DYK1011945P Recall
Medline Convenience Kits PPE Kit (Model DYK1011945P) may not be properly sterilized due to calibration issues with the sterilization equipment. This could …
Medline Industries, LP
Medline Convenience Kits Recall
Medline is recalling Lithotomy Packs and Lap Basin kits because sterilization equipment calibration problems may have compromised the sterility of these medical …
Medline Industries, LP
Medline Triple Lumen Insertion Kit Recall
Medline is recalling Triple Lumen Insertion Kits due to sterilization equipment calibration issues that may have compromised the sterility of the devices. Use …
Medline Industries, LP
Medline Surgical Biopsy Kits Recall
Medline is recalling multiple surgical and biopsy kits due to potential sterilization issues. Equipment calibration problems could affect whether these sterile …
Medline Industries, LP
WHILL Model C2 Powered Wheelchair Recall
WHILL is recalling certain Model C2 powered wheelchairs because a security vulnerability in the chair's Bluetooth Low Energy (BLE) communication could allow an …
WHILL, INC.
Medline Dressing Change Kit Recall
Medline medical convenience kits are being recalled because they contain BD ChloraPrep Triple Swabsticks with potentially open seals on the applicator …
Medline Industries, LP
LSL Healthcare Central Line Dressing Kit Recall
LSL Healthcare's Central Line Dressing Kit (Model 2519CP) is being recalled because the BD ChloraPrep Triple Swabsticks component inside has packaging with an …
LSL Healthcare Inc.
Canon VANTAGE GALAN 3T MRI Recall
Canon Medical's VANTAGE GALAN 3T MRI machines may develop ice in the magnet venting system. During an emergency shutdown (quench), helium gas could become …
Canon Medical System, USA, INC.
Genesis Push-In Suture Anchor Recall
Genesis Push-In Suture Anchors manufactured by Aju Pharm Co., Ltd. are being recalled due to reports of device failure, including anchor breakage, bending, …
Aju Pharm Co., Ltd.
AlternatiV+ Screw-In Anchor Recall
Aju Pharm's AlternatiV+ Screw-In Anchor surgical implant has been recalled due to reports of device failure, including breakage, bending, pull-out, and suture …
Aju Pharm Co., Ltd.
Medline Strykeflow 2 Suction Irrigator Recall
Medline robotics urology prostate kits containing Stryker Strykeflow 2 Suction Irrigators may leak or emit vaporized saline during use due to a 2024 design …
Medline Industries, LP
Vortex Surgical 25GA Convenience Kit Recall
Vortex Surgical 25GA Convenience Kits may have voids in the Tyvek pouch seals, compromising the sterile barrier and risking bacterial contamination. This could …
Vortex Surgical Inc.
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.
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
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