Medical Device Recalls
RSS ↗8,689 medical device recalls from federal enforcement feeds.
Showing 1,401–1,450 of 8,689
- Class II
Medical Device Recall · March 11, 2026
FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET REF ASK-05502-BSM UDI code: (01)10801902209853(17)270831(11)251210(10)33F25K0409 The Arrow Epidural CatheDue to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
- Class II
Medical Device Recall · March 11, 2026
PERCUTANEOUS SHEATH INTRODUCER with 7.5 - 8 Fr. Catheter REF ASK-09903-MGH3 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 The Arrow¿ percutaneous sheath introducer permits venousDue to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
- Class II
Medical Device Recall · March 11, 2026
Windstone Medical Packaging, Inc.
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).
- Class II
Medical Device Recall · March 11, 2026
Windstone Medical Packaging, Inc.
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).
- Class I
Medical Device Recall · March 11, 2026
Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06Reloads for curved-tipped stapler may potentially produce an incomplete staple line.
- Class II
Medical Device Recall · March 11, 2026
Arrowg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-21142-DMC UDI code: (01)10801902218930(17)270630(11)251211(10)33F25M0671 The MAC Multi-LumenDue to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
- Class II
Medical Device Recall · March 11, 2026
Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code: (01)10801902220315(17)261231(11)251210(10)33F25J0347 This device is intended for injection or aspiration of fluids. The needle protecDue to receiving a notice from a supplier that the liquid adhesive were incorrectly manufactured
- Class II
Medical Device Recall · March 11, 2026
ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER REF ASK-42802-PLH UDI code: (01)10801902133110(17)261231(11)251211(10)33F25L0140 REF ASK-45703-MGH UDIDue to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
- Class II
Medical Device Recall · March 11, 2026
Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter.Ventricular fibrillation (VF) occurred during radiofrequency (RF) therapy with the Medtronic Sphere-9 catheter in patients who have a Biotronik Implantable Cardioverter Defibrillator (ICD) or Biotronik Cardiac Resynchronization Therapy-Defibrillator (CRT-D) implanted. The observation is caused by an interaction between the Sphere-9 catheter current flow and a safety feature built into Biotronik ICDs and CRT Ds. Medtronic recommends physicians use increased caution when using the Sphere-9 catheter for RF ablation therapy in patients implanted with a Biotronik ICD/CRT-D system, and to ensure external defibrillation systems are readily available.
- Class II
Medical Device Recall · March 11, 2026
MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-11142-LC2 UDI code: (01)10801902206807(17)270531(11)251211(10)33F25M0670 The MAC Multi-Lumen Central Venous AcceDue to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
- Class II
Medical Device Recall · March 10, 2026
Siemens Medical Solutions USA, Inc
ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Despite the reported dose showing significantly higher, the actual applied x-ray dose levels are in accordance with the system settings and imaging conditions, as well as the applicable regulatory requirements.
- Class II
Medical Device Recall · March 10, 2026
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 USAn internal component of the actuators in a certain production batch may not meet the required mechanical strength. This could result, in the worst case scenario, in a sudden loss of the actuator's ability to hold the load, leading to rapid and uncontrolled downward movement of the lifting arm.
- Class II
Medical Device Recall · March 9, 2026
Siemens Medical Solutions USA, Inc
ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray systemDuring patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.
- Class II
Medical Device Recall · March 9, 2026
LSL Healthcare, Infant Central Line Dressing Change Kit, Model/Catalog Number: 2925HMedical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
- Class II
Medical Device Recall · March 9, 2026
nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute 90-300-251008: nanOss 3D Advanced Bone Graft Substitute, 25x100x8mm, 20cc 90-300-25508: nanOss 3D Advanced BProducts were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years.
- Class II
Medical Device Recall · March 9, 2026
LSL Healthcare, Standard Central Line Dressing Change Kit, Model/Catalog Number: 2717JMedical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
- Class II
Medical Device Recall · March 9, 2026
LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2717HMedical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
- Class II
Medical Device Recall · March 9, 2026
LSL Healthcare, IV Start Kit, Model/Catalog Number: 3131Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
- Class II
Medical Device Recall · March 9, 2026
Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Catalog Number: VAC-6000MT Product Description: The Clinical Innovations Kiwi is a disposable vacuumDue to complaints of device breakage at the traction force gauge to handle joint.
- Class II
Medical Device Recall · March 9, 2026
LSL Healthcare Wound Closure Tray, Model/Catalog Number: 7554Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
- Class II
Medical Device Recall · March 9, 2026
Siemens Medical Solutions USA, Inc
ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS icono floor Model 11327700. interventional fluoroscopic x-ray systemDuring patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.
- Class II
Medical Device Recall · March 9, 2026
LSL Healthcare, Foley Urine Collection Kit, Model/Catalog Number: 1555Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
- Class II
Medical Device Recall · March 9, 2026
VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SSThere is a possibility of reagent leakage from the specimen container.
- Class II
Medical Device Recall · March 7, 2026
Philips Spectral CT on Rails. Model Number: 728334.Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing Go. 2. Potential where the message of Previous Surview Exists Select Previous Surview? <Yes> or <No> should display but does not appear. 3. After performing Surview and planning the Brain Helical acquisition by setting Brain Area DoseRight Index to increase the dose, there is the potential that the Define Head Area option in the context menu is grayed out.
- Class II
Medical Device Recall · March 6, 2026
Uvlizer c/o RAIS INTERNATIONAL LLC
The product is a handheld ultraviolet-C germicidal wand and contains two low-pressure mercury bulbs with a peak emission wavelength at 254 nm.In some foreseeable use conditions, the Products can expose nearby persons to UVC radiation at levels significantly above limits recommended by international safety guidelines for skin and eye exposure.
- Class II
Medical Device Recall · March 6, 2026
Uvlizer c/o RAIS INTERNATIONAL LLC
The product is a handheld ultraviolet-C germicidal wand and contains a combination of five UV-A and UV-C LED lights. The product comes in two configurations: UV-C x 1; UV-A x 4, or UV-C x 2; UV-A x 3.In some foreseeable use conditions, the products can expose nearby persons to UVC radiation at levels significantly above limits recommended by international safety guidelines for skin and eye exposure.
- Class II
Medical Device Recall · March 6, 2026
Integra LifeSciences Corp. (NeuroSciences)
CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.Software issue that renders the touch screen unresponsive.
- Class II
Medical Device Recall · March 5, 2026
COOK MEDICAL Spectrum¿ Central Venous Catheter Set: Reference Part Number C-UDLM-401J-ABRM-HC, Order Number G43983; Reference Part Number C-UDLM-401J-ABRM-HC-CAH, Order Number G24754; Reference PProducts from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- Class II
Medical Device Recall · March 5, 2026
COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G, Order Number G50788; Reference Part Number CMW-14-300-18G, Order Number G50792Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- Class II
Medical Device Recall · March 5, 2026
COOK MEDICAL Thal-Quick Chest Tube Tray: Reference Part Number C-TQTSY-3200, Order Number G07242Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- Class II
Medical Device Recall · March 5, 2026
COOK MEDICAL Cook Staged Extubation Set: Reference Part Number C-CAE-14.0-83-EXTU, Order Number G24073Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- Class II
Medical Device Recall · March 5, 2026
COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order Number G50786Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- Class II
Medical Device Recall · March 5, 2026
COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G, Order Number G50787; Reference Part Number CMW-14-300-12G, Order Number G50791Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- Class II
Medical Device Recall · March 5, 2026
Photera 600 3-D, phototherapy device; Ultraviolet Lamp For Dermatologic DisordersCalibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).
- Class II
Medical Device Recall · March 5, 2026
Photera 600, phototherapy device; Ultraviolet Lamp For Dermatologic DisordersCalibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).
- Class II
Medical Device Recall · March 5, 2026
Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small, Cat. No. ARS1041101 2. TORNIER HRS Max Tuberosity Body No Coat, Small, Cat. No. ARS1041102 3. TORNIER HRS Max Trial,Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatible with the Tornier HRS system only, and are incompatible with the Tornier HRS Max system.
- Class II
Medical Device Recall · March 5, 2026
COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, Order Number G29775Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- Class II
Medical Device Recall · March 5, 2026
COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-FLEX-HC, Order Number G32092; Reference Part Number C-PTIS-100-HC, Order Number G12115.Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- Class II
Medical Device Recall · March 5, 2026
Photera 400, phototherapy device; Ultraviolet Lamp For Dermatologic DisordersCalibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).
- Class II
Medical Device Recall · March 5, 2026
COOK MEDICAL Wayne Pneumothorax Tray: Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; ReferenceProducts from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- Class II
Medical Device Recall · March 5, 2026
COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412; Reference Part Number APMY-4.0-21J-1-12, Order Number G58419Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- Class II
Medical Device Recall · March 5, 2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Vue Motion V12. Product Number: 1017979.Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence.
- Class II
Medical Device Recall · March 5, 2026
COOK MEDICAL NCompass¿ Nitinol Stone Extractor: Reference Part Number C-NTSE-2.4-115-NC3, Order Number G36250; Reference Part Number C-NTSE-2.4-115-NCT4, Order Number G36251.Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- Class II
Medical Device Recall · March 5, 2026
COOK MEDICAL Spectrum¿ Central Venous Tray: Reference Part Number C-UQLMYJ-1001J-RSC-ABRM-HC-FST-A-RD, Order Number G44800; Reference Part Number C-UTLMYJ-701J-ABRM-HC-IHI-FST-A-RD, Order Number G4Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- Class II
Medical Device Recall · March 5, 2026
COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-HC-G-EU, Order Number G57685; Reference Part Number C-PTIS-100-HC-G-NA, Order Number G576Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- Class II
Medical Device Recall · March 5, 2026
COOK MEDICAL Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0003, Order Number G56424; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0018, Order NumbeProducts from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- Class II
Medical Device Recall · March 5, 2026
Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part Number C-TCCSB-500-UNI, Order Number G32193; Reference Part Number C-TCCSB-500-UNI-01, Order Number G47665.Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- Class II
Medical Device Recall · March 5, 2026
COOK MEDICAL Cook¿ Strange Bile Duct Stone Exploration Set: Reference Part Number C-CSRC-7.5D-40-STRANGE, Order Number G09108Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- Class II
Medical Device Recall · March 5, 2026
COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IMH, Order Number G56532; Reference Part Number C-UTPT-1400-WAYNE-112497-IMH, Order Number G56535.Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- Class II
Medical Device Recall · March 5, 2026
COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA, Order Number G57703; Reference Part Number C-PTISY-100-UNL-HC-G-NA, Order NumProducts from the affected device lots were labeled with expiration dates that exceed the true shelf life.