Medical device recalls
38684 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2024-11-20FDA-DeviceDraeger Medical, Inc.Class IBrand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Component: Not applicable
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
- 2024-11-20FDA-DeviceDraeger Medical, Inc.Class IBrand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component: Not applicable
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
- 2024-11-20FDA-DeviceBoston Scientific CorporationClass IBoston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number M004CRBS4000; CONSOLE REFURB: Material Number M004CRBS400R0; CONSOLE HOSPITAL, Material Number M004CRBS400H0, CONSOLE ZERO, Material Number M004CRBS400Z0
Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
- 2024-11-20FDA-DeviceBoston Scientific CorporationClass IBoston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS2160
Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
- 2024-11-20FDA-DeviceBoston Scientific CorporationClass IBoston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110
Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
- 2024-11-20FDA-DeviceBoston Scientific CorporationClass IBoston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS2060
Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
- 2024-11-20FDA-DeviceBoston Scientific CorporationClass IBoston Scientific POLARx FIT BALLOON CATHETER ST OUS, Material Number M004CRBS2010
Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
- 2024-11-20FDA-DeviceBoston Scientific CorporationClass IBoston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100
Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
- 2024-11-20FDA-DeviceBoston Scientific CorporationClass IBoston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000.
Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
- 2024-11-20FDA-DevicePhilips Respironics, Inc.Class ILifeVent EVO2. Model Number: SP2100X26B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.
Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.
- 2024-11-20FDA-DevicePhilips Respironics, Inc.Class IGarbin Evo. Model Number: LD2110X23B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.
Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.
- 2024-11-20FDA-DevicePhilips Respironics, Inc.Class IAeris EVO. Model Number: VT2110X24B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.
Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.
- 2024-11-20FDA-DevicePhilips Respironics, Inc.Class ITrilogy EV300. Model Numbers: DS2200X11B, IN2200X15B, BL2200X15B, BR2200X18B, CA2200X12B, DE2200X13B, GB2200X15B, ND2200X15B, ES2200X15B, FR2200X14B, FX2200X15B, EU2200X15B, IA2200X15B, IT2200X21B, KR2200X15B, TR2200X15B, EE2200X15B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.
Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.
- 2024-11-20FDA-DevicePhilips Respironics, Inc.Class ITrilogy Evo Universal Ventilator. Model Number DS2000X11B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.
Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.
- 2024-11-20FDA-DevicePhilips Respironics, Inc.Class ITrilogy Evo. Model Numbers: DS2110X11B, UDS2110X11B, RDS2110X11B, CA2110X12B, JP2110X16B, IN2110X15B, DE2110X13B, AU2110X15B, BL2110X15B, EU2110X15B, BR2110X18B, LA2110X15B, EE2110X15B, FR2110X14B, GB2110X15B, ND2110X15B, ES2110X15B, IA2110X15B, IT2110X21B, KR2110X15B, TR2110X15B, EU2110X19, FP2110X10, PP2110X10, RBRBR2110X18B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport setti
Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.
- 2024-11-20FDA-DevicePhilips Respironics, Inc.Class ITrilogy Evo O2. Model Numbers: FP2100X10, DS2100X11B, IN2100X15B, DE2100X13B, IA2100X15B, EU2100X15B, LA2100X15B, EE2100X15B, FX2100X15B, ES2100X15B, ND2100X15B, FR2100X14B, IT2100X21B, JP2100X16B, IN2100X19, EU2100X19. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.
Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.
- 2024-11-13FDA-DeviceSmith & Nephew, Inc.Class IITandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.
The Bipolar assembly contains an oversized Retainer Ring.
- 2024-11-13FDA-DeviceBaxter Healthcare CorporationClass IIHillrom Welch Allyn XScribe Cardiac Stress Testing System; Programmable Diagnostic Computer
There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.
- 2024-11-13FDA-DeviceBaxter Healthcare CorporationClass IIHillrom Welch Allyn Diagnostic Cardiology Suite (formerly Connex Cardio); Diagnostic spirometer
There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.
- 2024-11-13FDA-DeviceBaxter Healthcare CorporationClass IIHillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph
There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.
- 2024-11-13FDA-DeviceBaxter Healthcare CorporationClass IIHillrom Welch Allyn RScribe 12-Lead Electrocardiograph System; Electrocardiograph
There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.
- 2024-11-13FDA-DeviceBaxter Healthcare CorporationClass IIHillrom Welch Allyn Q-Stress Cardiac Stress Testing System; cardiac stress test
There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.
- 2024-11-13FDA-DeviceBaxter Healthcare CorporationClass IIHillrom Welch Allyn HScribe Holter System; ambulatory monitoring
There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.
- 2024-11-13FDA-DeviceEthicon, Inc.Class IICoated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H
Complaints were received regarding needle pull-off and suture degradation. Analysis on returned product from this lot confirmed that some sutures were visually degraded in the package.
- 2024-11-13FDA-DeviceGE HealthcareClass IIGE Healthcare Centricity Universal Viewer Zero Footprint, Model Numbers: 1) 2089507-083, GDZH-JINWAN-Centricity 2) 2089507-093, 10510-3-Centricity Universal Viewer Zero Footprint / ZFP-02268286, 10510-3-Centricity Universal Viewer Zero Footprint / ZFP-02030900, 1495-1-Centricity Universal Viewer Zero Footprint / ZFP-02347996, 423834-Centricity Universal Viewer Zero Footprint / ZFP-02286658, 1407636-Centricity Universal Viewer Zero Footprint / ZFP-02304121, 651240-Centricity Universal Viewer
GE HealthCare has become aware of an issue in Centricity Universal Viewer Zero Footprint Client (ZFP) where there is a potential security vulnerability which could allow a malicious actor to access the system and potentially manipulate patient data.
- 2024-11-13FDA-DeviceSHIMADZU CORPORATION MEDICAL SYSTEMS DIVISIONClass IIThe FLUOROspeed is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. FLUOROspeed may be used for emergency treatment on an outpatient basis, as well as for bedside examinations.
X-ray R/F system software with certain versions of the control board may occasionally fail to display images when switching from Fluoroscopy mode to Radiography mode, which may lead to the possibility of delay or cancellation of the examination.
- 2024-11-13FDA-DeviceSHIMADZU CORPORATION MEDICAL SYSTEMS DIVISIONClass IISONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable for radiographic and fluoroscopic examinations, including general radiography and pediatric examinations, excluding mammography.
X-ray R/F system software with certain versions of the control board may occasionally fail to display images when switching from Fluoroscopy mode to Radiography mode, which may lead to the possibility of delay or cancellation of the examination.
- 2024-11-13FDA-DeviceBiocare Medical, LLCClass IIintelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB Buffer, Catalog Number: IPBF5009G20; ONCORE Pro DAB Chromogen, REF: OPRI6056KT180, containing DAB Buffer, Catalog Number: OPRI6055T60; IP DAB Chromogen Kit 80 ml, REF: IPK5010G80, containing DAB Buffer, Catalog Number: IPBF5009G20; DAB kit, REF: OPRI6056KT180, containing DAB Buffer, Catalog Number: OPRI6055T60 Folate Receptor alpha IHC Assay Kit, REF: IPI4006KG10, containing DAB Buffer, Catalog Number: IPBF5009G20
Kits containing the DAB chromogen buffer, intended for use in either manual or automated Immunohistochemistry (IHC) staining protocols, may produce weak to no staining, which may lead to test failure requiring the test to be repeated.
- 2024-11-13FDA-DeviceNihon Kohden America IncClass IIAdult Cap-ONE Biteblock REF YG-227T The cap-ONE Biteblock is intended to sample CO2 and administer supplemental oxygen, for patients who can wear a 20mm bite block, during endoscopy type procedures. The device is intended for single patient use only.
Due to products being shipped/distributed to customers after the products expiration date had past.
- 2024-11-13FDA-DeviceBeckman Coulter, Inc.Class IIThe Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine using the Access Immunoassay Systems.
The Access Cortisol assay protocol file (APF) applies an incorrect calibration curve acceptance parameter at the S1 calibrator level that can lead to a high rate of calibration failures which can vary by reagent lot number. Calibration failure would lead to delay of measurement results reporting and potential injuries.
Get notified about new device recalls
Free weekly digest. We email when a new federal recall in this category — or anything else affecting your household — is published.
Get the Sunday Brief