Medical Device Recalls
RSS ↗7,959 medical device recalls from federal enforcement feeds.
Showing 701–750 of 7,959
- 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
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
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
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 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 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
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 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 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 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 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
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 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 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 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
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-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 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 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 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 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
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 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
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
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
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 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.
- 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 4, 2026
Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog Number: ES-100V3 (device); BT2M20S8C (2 MHz fetal probe). Software Version: N/A ProductProduct labeling includes a fetal indication for use that is not cleared under its 510(k).
- Class II
Medical Device Recall · March 3, 2026
Soft-Vu Angiographic Catheter, Headhunter (1), Non-Braided; SOFT-VU HH1 4F X 100CM 038 NB 0SH; Catalog No.: 10714040; Product/UPN No.: H787107140405 (Box), H787107140400 (Pouch); Box Quantity: 5 pThe affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- Class II
Medical Device Recall · March 3, 2026
Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 100CM 038 NB 0SH; Catalog No.: 10714021; Product/UPN No.: H787107140215 (Box), H787107140210 (Pouch); Box Quantity: 5 pouches;The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- Class II
Medical Device Recall · March 3, 2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only);Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- Class II
Medical Device Recall · March 3, 2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229;Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- Class II
Medical Device Recall · March 3, 2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
ALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025;Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- Class II
Medical Device Recall · March 3, 2026
Soft-Vu Angiographic Catheter, Cobra (1), Non-Braided; SOFT-VU CB1 4F X 100CM 038 NB 0SH; Catalog No.: 10714017; Product/UPN No.: H787107140175 (Box), H787107140170 (Pouch); Box Quantity: 5 poucheThe affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- Class II
Medical Device Recall · March 3, 2026
OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystemOxoid Ltd., part of Thermo Fisher Scientific, confirmed that Microbact 12L Kit 20 Tests MB1128A lot 4494873 may identify incorrect organism due to inconclusive result from ambiguous color reactions in wells.
- Class II
Medical Device Recall · March 3, 2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20/20; System Code: 722038;Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- Class II
Medical Device Recall · March 3, 2026
AccuVu Angiographic Catheter, Straight Flush, Non-Braided, With 10 R/O Markers; ACCU-VU STR FL 4F X 100CM 035 NB 6SH 10 R/O 6@1CM 4@5CM; Catalog No.: 13709604; Product/UPN No.: H787137096045 (Box),The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- Class II
Medical Device Recall · March 3, 2026
Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 035 NB 6SH; Catalog No.: 10732301; Product/UPN No.: H787107323015 (Box), H787107323010 (Pouch); Box Quantity: 10 units;The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- Class II
Medical Device Recall · March 3, 2026
Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 035 NB 0SH; Catalog No.: 10734301; Product/UPN No.: H787107343015 (Box), H787107343010 (Pouch); Box Quantity: 5 pouches;The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- Class II
Medical Device Recall · March 3, 2026
Soft -Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 038 NB 0SH; Catalog No.: 10710013; Product/UPN No.: H787107100135 (Box), H787107100130 (Pouch); Box Quantity: 5 pouches;The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- Class II
Medical Device Recall · March 3, 2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20/15; System Code: 722058;Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- Class II
Medical Device Recall · March 3, 2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- Class II
Medical Device Recall · March 3, 2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 5 M12; System Code: (1)722227, (2)722231;Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.