Medical Device Recalls

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8,689 medical device recalls from federal enforcement feeds.

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Showing 2,351–2,400 of 8,689

Medical Device Recall · November 10, 2025
Draeger, Inc.
ErgoStar CM 55, Model/Catalog Number: MP01855, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a m
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
Class I
Medical Device Recall · November 10, 2025
Draeger, Inc.
ErgoStar CM 45, Model/Catalog Number: MP01845, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a me
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
Class I
Medical Device Recall · November 7, 2025
Intuitive Surgical, Inc.
Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System Model/Catalog Number: IS4000; IS4200; IS5000 Software Version: N/A Product Description: The da Vinc
Due to a software implementation error that allowed instruments arms failing an important diagnostic test to remain in clinical use. This test was supposed to be used to detect Universal Surgical Manipulator insertion axis ball screws that exhibit the symptoms of being bent and misaligned which is a precursor to potential ball screw fatigue failure/fraction
Class II
Medical Device Recall · November 7, 2025
Rocket Medical Plc
Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-12-PK Product Description: Chest tube manufactured from PVC, with fenestrations and a bar
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
Class II
Medical Device Recall · November 7, 2025
Rocket Medical Plc
Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-18-SG Software Version: N/A Product Description: Chest tube manufactured from PVC, wi
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
Class II
Medical Device Recall · November 7, 2025
Rocket Medical Plc
Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-18-PK Software Version: N/A Product Description: Chest tube manufactured from PVC, with
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
Class II
Medical Device Recall · November 7, 2025
Beckman Coulter, Inc.
Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the Access 2 Immunoassay system, Catalog Number 81901
It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing deformities. The bottom (round end) of the Reaction Vessel may have a small protrusion or hair like deformity. This could cause causing instrument errors (e.g., pipetting, rake, wash carousel errors) that could delay patient results.
Class II
Medical Device Recall · November 7, 2025
Rocket Medical Plc
Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-12-SG Software Version: N/A Product Description: Chest tube manufactured from PVC, wi
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
Class II
Medical Device Recall · November 7, 2025
Rocket Medical Plc
Brand Name: Rocket Product Name: Rocket 20Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-20-PK Software Version: N/A Product Description: Chest tube manufactured from PVC, with
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
Class II
Medical Device Recall · November 7, 2025
Rocket Medical Plc
Brand Name: Rocket Product Name: Rocket 16Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-16-PK Software Version: N/A Product Description: Chest tube manufactured from PVC, with
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
Class II
Medical Device Recall · November 6, 2025
C.R. Bard Inc
Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Class II
Medical Device Recall · November 6, 2025
C.R. Bard Inc
BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit REF 788426
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Class II
Medical Device Recall · November 6, 2025
C.R. Bard Inc
BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit REF 78826
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Class II
Medical Device Recall · November 6, 2025
CareFusion 303, Inc.
BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System with Guardrails" Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent a
Due to a number of modules flashed with a date and time associated with the daylight savings time (DST) adjustment that may cause connectivity issue with hospital networks. This issue only affects the Interoperability workflow for devices with a DST invalid timestamp, impacting connectivity of the PCU to the hospital network
Class II
Medical Device Recall · November 6, 2025
Bard Peripheral Vascular Inc
Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T,
Acute drainage catheters, indicated for use in removing fluid during acute drainage/aspiration procedure, manufactured with safety indicators that erroneously show catheter in sharp position when catheter is in blunt position, which may lead users to believe device is not yet in pleural or peritoneal space when it is, may cause discomfort, delay to treatment, injury to internal organs or vessels.
Class II
Medical Device Recall · November 6, 2025
C.R. Bard Inc
BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Class II
Medical Device Recall · November 6, 2025
PATH
MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)
Following a component change in the DPOAE probe (speaker replacement), technical distortions may occur at high stimulus levels combined with unusually low OAE amplitude acceptance thresholds. These distortions can mimic true DPOAE responses and may result in a false PASS outcome.
Class II
Medical Device Recall · November 5, 2025
Diasol, Inc
Brand Name: Diasol Product Name: 100325-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Safety and efficacy of dialysis acid concentrate cannot be assured
Class II
Medical Device Recall · November 5, 2025
Diasol, Inc
Brand Name: Diasol Product Name: 100125-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Safety and efficacy of dialysis acid concentrate cannot be assured
Class II
Medical Device Recall · November 5, 2025
Diasol, Inc
Brand Name: Diasol Product Name: 100230-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Safety and efficacy of dialysis acid concentrate cannot be assured
Class II
Medical Device Recall · November 5, 2025
Accriva Diagnostics, Inc.
Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System
Test cuvettes, used with an assay for monitoring heparin anticoagulation, may have a foreign object that has sharp edges and could pose a risk of injury if not detected prior to handling.
Class II
Medical Device Recall · November 5, 2025
Cepheid
Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
Product testing did not meet expected stability criteria.
Class II
Medical Device Recall · November 5, 2025
Diasol, Inc
Brand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Safety and efficacy of dialysis acid concentrate cannot be assured
Class II
Medical Device Recall · November 5, 2025
Diasol, Inc
Brand Name: Diasol Product Name: 100225-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Safety and efficacy of dialysis acid concentrate cannot be assured
Class II
Medical Device Recall · November 5, 2025
Diasol, Inc
Brand Name: Diasol Product Name: 100220-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Safety and efficacy of dialysis acid concentrate cannot be assured
Class II
Medical Device Recall · November 4, 2025
Datascope Corp.
Cardiosave Rescue. Intra-Aortic Balloon Pump system.
The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
Class II
Medical Device Recall · November 4, 2025
Datascope Corp.
Cardiosave Hybrid. Intra-Aortic Balloon Pump system.
The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Biological Age & Longevity Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Gut Microbiome Test Large
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Food Sensitivity Test Small
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Neurotransmitters XL
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Iron Deficiency Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
3 in 1 STI Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Herpes (HSV-1 & HSV-2) Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Pollen Allergy Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Menopause (FSH) 2 Tests
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Iodine Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
GI Microbiome Profile Small
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Pregnancy Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Allergy & Food Intolerance Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Food Sensitivity Test Large
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Blood Type Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Liver Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Mycotoxin Panel Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Thyroid TSH Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Fructose Intolerance Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Neurotransmitters Basic
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Gut Microbiome Test Mega
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Epstein-Barr Virus (EBV VCA & EBNA IgG) Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Trichomonas Vaginalis test
Distribution without premarket approval/clearance.
Class II