Medical device recalls (page 15)
2545 recalls.
- Oncology Kit w/60" recall (ICU Medical, Inc.)
Medical deviceClass IIReported May 27, 2026 · Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak... - Tangent Endoscopy recall (TANGENT ENDOSCOPY, LLC)
Medical deviceClass IIReported May 27, 2026 · Affected devices exhibited fractures at the distal shaft tip without complete detachment. - Swan-Ganz Pacing Catheter recall (Becton, Dickinson and Company)
Medical deviceClass IIReported May 27, 2026 · Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection... - Swan-Ganz Jr Catheter recall (Becton, Dickinson and Company)
Medical deviceClass IIReported May 27, 2026 · Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection... - Swan-Ganz Catheter recall (Becton, Dickinson and Company)
Medical deviceClass IIReported May 27, 2026 · Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection... - Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application recall (Medtronic Neuromodulation)
Medical deviceClass IIReported May 20, 2026 · Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in... - LVIS Intraluminal Support Device recall (MICROVENTION INC.)
Medical deviceClass IIReported May 20, 2026 · Stent-assisted coiling device may due to commingling during manufacturing have dimensional nonconformance and/or incorrect device configuration. If device is... - Medtronic Marinr Steerable recall (Stryker Sustainability Solutions)
Medical deviceClass IIReported May 20, 2026 · Incomplete seals on sterile product - Daig Livewire Steerable BDB recall (Stryker Sustainability Solutions)
Medical deviceClass IIReported May 20, 2026 · Incomplete seals on sterile product - Daig Livewire Steerable recall (Stryker Sustainability Solutions)
Medical deviceClass IIReported May 20, 2026 · Incomplete seals on sterile product - Daig Livewire Steerable recall (Stryker Sustainability Solutions)
Medical deviceClass IIReported May 20, 2026 · Incomplete seals on sterile product - Daig Livewire Steerable recall (Stryker Sustainability Solutions)
Medical deviceClass IIReported May 20, 2026 · Incomplete seals on sterile product - Daig Livewire Steerable recall (Stryker Sustainability Solutions)
Medical deviceClass IIReported May 20, 2026 · Incomplete seals on sterile product - Daig Livewire Steerable recall (Stryker Sustainability Solutions)
Medical deviceClass IIReported May 20, 2026 · Incomplete seals on sterile product - Daig Livewire Steerable recall (Stryker Sustainability Solutions)
Medical deviceClass IIReported May 20, 2026 · Incomplete seals on sterile product - Daig Livewire Steerable recall (Stryker Sustainability Solutions)
Medical deviceClass IIReported May 20, 2026 · Incomplete seals on sterile product - Daig Livewire Steerable recall (Stryker Sustainability Solutions)
Medical deviceClass IIReported May 20, 2026 · Incomplete seals on sterile product - Daig Livewire Steerable recall (Stryker Sustainability Solutions)
Medical deviceClass IIReported May 20, 2026 · Incomplete seals on sterile product - Daig Livewire Steerable recall (Stryker Sustainability Solutions)
Medical deviceClass IIReported May 20, 2026 · Incomplete seals on sterile product - Daig Livewire Steerable recall (Stryker Sustainability Solutions)
Medical deviceClass IIReported May 20, 2026 · Incomplete seals on sterile product - Daig Livewire Steerable recall (Stryker Sustainability Solutions)
Medical deviceClass IIReported May 20, 2026 · Incomplete seals on sterile product - CS Uni-Directional w Auto ID recall (Stryker Sustainability Solutions)
Medical deviceClass IIReported May 20, 2026 · Incomplete seals on sterile product - CS Uni-Directional w Auto ID recall (Stryker Sustainability Solutions)
Medical deviceClass IIReported May 20, 2026 · Incomplete seals on sterile product - BW Webster Duo-Decapolar recall (Stryker Sustainability Solutions)
Medical deviceClass IIReported May 20, 2026 · Incomplete seals on sterile product - BARD EP XT Steerable recall (Stryker Sustainability Solutions)
Medical deviceClass IIReported May 20, 2026 · Incomplete seals on sterile product - BARD EP XT Decapolar Steerable recall (Stryker Sustainability Solutions)
Medical deviceClass IIReported May 20, 2026 · Incomplete seals on sterile product - BARD Dynamic XT Steerable recall (Stryker Sustainability Solutions)
Medical deviceClass IIReported May 20, 2026 · Incomplete seals on sterile product - BARD Dynamic XT Steerable recall (Stryker Sustainability Solutions)
Medical deviceClass IIReported May 20, 2026 · Incomplete seals on sterile product - BARD Dynamic XT Deca Steerable recall (Stryker Sustainability Solutions)
Medical deviceClass IIReported May 20, 2026 · Incomplete seals on sterile product - BARD Dynamic Tip Steerable recall (Stryker Sustainability Solutions)
Medical deviceClass IIReported May 20, 2026 · Incomplete seals on sterile product - BARD Dynamic Tip Steerable recall (Stryker Sustainability Solutions)
Medical deviceClass IIReported May 20, 2026 · Incomplete seals on sterile product - BARD Dynamic Tip Steerable recall (Stryker Sustainability Solutions)
Medical deviceClass IIReported May 20, 2026 · Incomplete seals on sterile product - BARD Dynamic Deca Steerable recall (Stryker Sustainability Solutions)
Medical deviceClass IIReported May 20, 2026 · Incomplete seals on sterile product - Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product ID:... recall (Integra LifeSciences Corp. (NeuroSciences))
Medical deviceClass IIReported May 20, 2026 · Out-of-specification endotoxin result that did not meet the acceptance criteria. - Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO recall (Edwards Lifesciences, LLC)
Medical deviceClass IIReported May 20, 2026 · Labeling update to provide warning if functionality of the valve replacement delivery system is compromised. - ZYMUTEST HIA IgG recall (Aniara Diagnostica LLC)
Medical deviceClass IIReported May 20, 2026 · Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the... - Philips Azurion. System Code Description recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported May 20, 2026 · Potential for the bolts and plastic parts of the Cable Hose Carriers that hold the cable hose to the monitor ceiling suspension may loosen and/or break over... - QuickVue Dipstick Strep A Test recall (Quidel Corporation)
Medical deviceClass IIReported May 20, 2026 · Product has the potential for false positive results - 3DIMENSIONS MAMMOGRAPHY SYSTEM recall (Hologic, Inc)
Medical deviceClass IIReported May 20, 2026 · Complaints have been received of systems developing loose, missing, or broken internal bolts over time. - SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC recall (Hologic, Inc)
Medical deviceClass IIReported May 20, 2026 · Complaints have been received of systems developing loose, missing, or broken internal bolts over time. - Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The... recall (Stryker Corporation)
Medical deviceClass IIReported May 20, 2026 · Due to nonconforming products being inadvertently distributed. - Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom... recall (Dexcom, Inc.)
Medical deviceClass IIReported May 20, 2026 · A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend... - Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7... recall (Dexcom, Inc.)
Medical deviceClass IIReported May 20, 2026 · A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend... - Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7... recall (Dexcom, Inc.)
Medical deviceClass IIReported May 20, 2026 · A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend... - Diowave Laser System recall (Technological Medical Advancements LLC)
Medical deviceClass IIReported May 20, 2026 · Software update is needed for laser systems, for topical infrared heating to provide temporary relief of minor muscle and joint pain, spasms, stiffness... - LUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and 99576-000011 UDI-DI... recall (Jolife AB)
Medical deviceClass IIReported May 20, 2026 · Due to a subset of chest compression systems/devices where the service performed on the systems were not appropriately documented (The documents for the... - NextStep Antegrade Chronic Hemodialysis Catheter recall (ARROW INTERNATIONAL, LLC)
Medical deviceClass IReported May 20, 2026 · 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not... - Cannon II Plus Hemodialysis Catheter recall (ARROW INTERNATIONAL, LLC)
Medical deviceClass IReported May 20, 2026 · 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not... - Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-15192-VFI recall (ARROW INTERNATIONAL, LLC)
Medical deviceClass IReported May 20, 2026 · 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not... - Arrow Edge Hemodialysis Catheterization Product recall (ARROW INTERNATIONAL, LLC)
Medical deviceClass IReported May 20, 2026 · 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not... - Revolution Apex Select recall (GE Medical Systems, LLC)
Medical deviceClass IIReported May 20, 2026 · GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used... - Revolution Apex recall (GE Medical Systems, LLC)
Medical deviceClass IIReported May 20, 2026 · GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used... - Revolution CT ES recall (GE Medical Systems, LLC)
Medical deviceClass IIReported May 20, 2026 · GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used... - Revolution Apex Plus recall (GE Medical Systems, LLC)
Medical deviceClass IIReported May 20, 2026 · GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used... - Revolution Apex Elite recall (GE Medical Systems, LLC)
Medical deviceClass IIReported May 20, 2026 · GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used... - Revolution CT recall (GE Medical Systems, LLC)
Medical deviceClass IIReported May 20, 2026 · GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used... - Revolution Ascend recall (GE Medical Systems, LLC)
Medical deviceClass IIReported May 20, 2026 · GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used... - Medline medical convenience kits recall (Medline Industries, LP)
Medical deviceClass IReported May 20, 2026 · Medline has identified the presence of particulate within the fluid path of the Manifolds. - Medline medical convenience kits recall (Medline Industries, LP)
Medical deviceClass IReported May 20, 2026 · Medline has identified the presence of particulate within the fluid path of the Manifolds. - Medline medical convenience kits recall (Medline Industries, LP)
Medical deviceClass IReported May 20, 2026 · Medline has identified the presence of particulate within the fluid path of the Manifolds. - 1. 3 VALVE MAN KIT recall (Medline Industries, LP)
Medical deviceClass IReported May 20, 2026 · Medline has identified the presence of particulate within the fluid path of the Manifolds. - 1. DBD-MTS recall (Medline Industries, LP)
Medical deviceClass IReported May 20, 2026 · Medline has identified the presence of particulate within the fluid path of the Manifolds. - Medline medical convenience kits recall (Medline Industries, LP)
Medical deviceClass IReported May 20, 2026 · Medline has identified the presence of particulate within the fluid path of the Manifolds. - Namic Preceptor Manifold recall (Medline Industries, LP)
Medical deviceClass IReported May 20, 2026 · Medline has identified the presence of particulate within the fluid path of the Manifolds. - Namic Preceptor Manifold recall (Medline Industries, LP)
Medical deviceClass IReported May 20, 2026 · Medline has identified the presence of particulate within the fluid path of the Manifolds. - Namic Angiographic Manifold recall (Medline Industries, LP)
Medical deviceClass IReported May 20, 2026 · Medline has identified the presence of particulate within the fluid path of the Manifolds. - Namic Angiographic Manifold recall (Medline Industries, LP)
Medical deviceClass IReported May 20, 2026 · Medline has identified the presence of particulate within the fluid path of the Manifolds. - Namic Angiographic Manifold recall (Medline Industries, LP)
Medical deviceClass IReported May 20, 2026 · Medline has identified the presence of particulate within the fluid path of the Manifolds. - Brand Name: DONJOY Product Name: ICEMAN recall (DJO, LLC)
Medical deviceClass IIReported May 20, 2026 · Due to broken connector which may result in a temporary interruption of prescribed cold therapy. - Brand Name: DONJOY Product Name: ICEMAN W/ recall (DJO, LLC)
Medical deviceClass IIReported May 20, 2026 · Due to broken connector which may result in a temporary interruption of prescribed cold therapy. - Brand Name: DONJOY Product Name: ICEMAN W/ recall (DJO, LLC)
Medical deviceClass IIReported May 20, 2026 · Due to broken connector which may result in a temporary interruption of prescribed cold therapy. - Brand Name: DONJOY Product Name: ICEMAN CLASSIC CUBE Model/Catalog Number: 11-0494 ... recall (DJO, LLC)
Medical deviceClass IIReported May 20, 2026 · Due to broken connector which may result in a temporary interruption of prescribed cold therapy. - On-X Mitral Heart Valve with Conform-X Sewing Ring recall (On-X Life Technologies, Inc.)
Medical deviceClass IIReported May 20, 2026 · Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications. - Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes... recall (Windstone Medical Packaging, Inc.)
Medical deviceClass IReported May 20, 2026 · Affected kits contain Medline Namic RA Syringes, which are recalled by their manufacturer due to risk of syringe rotating adapter unwinding during use, which... - Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258920028 recall (Omnicell, Inc.)
Medical deviceClass IReported May 20, 2026 · Potential for mislabeled syringe produced by the i.v.STATION device. - ZENBONE recall (Orthorebirth Co Ltd)
Medical deviceClass IIReported May 13, 2026 · Resorbable bone void filler falls outside standard specifications. - BioCera Fibers recall (Orthorebirth Co Ltd)
Medical deviceClass IIReported May 13, 2026 · Resorbable bone void filler falls outside standard specifications. - Medline Surgical Packs: 1) PACK recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - See complete list in RES recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Surgical Drapes: 1) SHEET recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) ARTHROSCOPY CDS recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) KIT UROLOGY SLING recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) LVAD DRIVELINE TRAY recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) DRAPE PACK recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) DRAPE PACK-CHOICE recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) KIT GENERAL CLOSURE recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) BURN PACK recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) WMC I D PACK-LF recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) PICC CATHETER INSERTION TRAY recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) BASIC NERVE BLOCK TRAY W/LINEN recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) KIT STC TRACHEOSTOMY recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - See RES for complete list. Medline Convenience Kits: 1) SPINAL CDS recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) KIT OPHTHALMIC RUPTURE GLOBE recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) HYSTEROSCOPY recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) C-SECTION PACK recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - See full list in RES recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) OB KIT recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated...