Medical Device Recalls
RSS ↗8,689 medical device recalls from federal enforcement feeds.
Showing 5,351–5,400 of 8,689
- Class II
Medical Device Recall · October 16, 2024
CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX onlyRetroactive; Due to complaints, labeling correction for permanent tissue-integrating surgical matrices to include prevention and management of would dehiscence.
- Class II
Medical Device Recall · October 16, 2024
Acrobat-i Positioner. Model Number C-XP-5000ZDeviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2-year shelf life.
- Class II
Medical Device Recall · October 16, 2024
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE procedure kits labeled as follows: 1) 20G EPI CATH SINGLE STERILE, REF EPICATH19 2) 20G EPI CATH SINGLE STERILE, REF EPICATH20The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
- Class II
Medical Device Recall · October 16, 2024
Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000ZDeviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2-year shelf life.
- Class II
Medical Device Recall · October 16, 2024
Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000ZDeviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2-year shelf life.
- Class II
Medical Device Recall · October 16, 2024
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE procedure kits labeled as follows: 1) PERIPHERAL CONTINUOUS NERVE BL, REF PAIN1423A; 2) CONT. 20G EPI MRI COMPATIBLE, REF PAIN1470A; 3) EPIDURAL CATHETERIZATION KIT, REF PAIN1644The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
- Class II
Medical Device Recall · October 16, 2024
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE procedure kits labeled as follows: 1) CONT EPI 20G W/HUSTEAD, REF PAIN1069B; 2) CSE TRAY, REF PAIN1941; 3) TRAY CON EPID 20G NYL W/TUOHY, REF PAIN9023; 4) TRAY, CONT EPI 20G NYL W/ HUST,The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
- Class II
Medical Device Recall · October 15, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline Shoulder Repair Pack-LF, REF DYNJ82607, 2 kits/case, sterile.Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.
- Class II
Medical Device Recall · October 15, 2024
Tandem 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.
- Class II
Medical Device Recall · October 15, 2024
MEDLINE INDUSTRIES, LP - Northfield
(1) Medline Open Heart CDS, REF CDS840132O, packaged 1 kit/case, non-sterile; and (2) Medline Dr. Davies CV, REF DYNJ903016G, packaged 1 kit/case, non-sterile.Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.
- Class II
Medical Device Recall · October 15, 2024
MEDLINE INDUSTRIES, LP - Northfield
(1) Medline Pacer Implant Pack, REF DYNJ59194A, 4 kits/case, sterile; and (2) Medline Thoracotomy Morristown, REF DYNJ904220F, 1 kit/case, non-sterile.Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.
- Class II
Medical Device Recall · October 15, 2024
OrganOx metra -Intended as a Normothermic Machine Perfusion system of donor transport livers. Model/Catalog Number: D0003 The OrganOx metra is a transportable device intended to be used to sustaBattery movement led to damage of one of the battery cells causing it to short to the battery retention bracket
- Class III
Medical Device Recall · October 15, 2024
a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING, SALEM SUMP, 14 FR; b) Alcon Custom-Pak DR GREEN VITRECTOMY MERCY HOSPITAL, # 6557-59 and # 6557Reported breakage in the tubing Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made.
- Class I
Medical Device Recall · October 15, 2024
Brand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 8621400 The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates.The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
- Class I
Medical Device Recall · October 15, 2024
Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component: Not applicableThe Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
- Class I
Medical Device Recall · October 15, 2024
Brand Name: Atlan Product Name: Atlan A300 Model/Catalog Number: 8211300 The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates.The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
- Class I
Medical Device Recall · October 15, 2024
Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Component: Not applicableThe Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
- Class II
Medical Device Recall · October 14, 2024
Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789Devices from the affected device lots have labels that state the incorrect expiration dates.
- Class II
Medical Device Recall · October 14, 2024
Defibtech DDP-2002: Pediatric Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, Lifeline ECG, Lifeline View (DDU-2XXX Series -Indicated for use on victims of suddenWithin the Irish Market, that a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an unauthorized label applied, could potentially lead to expired Defibtech AED Pads appearing as though they are within the acceptable shelf life.there is a possibility of hydrogel drying, which may result in poor electrical connection to the patient, which can reduce the energy delivered to the patient
- Class II
Medical Device Recall · October 14, 2024
Defibtech DDP-200P: Pediatric Defibrillation Pads 0 For use with AED Models: Lifeline and Lifeline Auto (DDU-l XX Series)-Indicated for use on victims of sudden cardiac arrest (SCA.)Within the Irish Market, that a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an unauthorized label applied, could potentially lead to expired Defibtech AED Pads appearing as though they are within the acceptable shelf life.there is a possibility of hydrogel drying, which may result in poor electrical connection to the patient, which can reduce the energy delivered to the patient
- Class II
Medical Device Recall · October 14, 2024
Defibtech DDP-2001: Adult Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, lifeline ECG, lifeline View (DDU-2XXX Series). -Indicated for use on victims of sudden cardiacWithin the Irish Market, that a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an unauthorized label applied, could potentially lead to expired Defibtech AED Pads appearing as though they are within the acceptable shelf life.there is a possibility of hydrogel drying, which may result in poor electrical connection to the patient, which can reduce the energy delivered to the patient
- Class II
Medical Device Recall · October 14, 2024
Defibtech DDP-100 Adult Defibrillation Pads For use with AED Models: Lifeline and Lifeline Auto (DDU-1:XX Series)- Indicated for use on victims of sudden cardiac arrest (SCA)Within the Irish Market, a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an unauthorized label applied, could lead to expired Defibtech AED Pads appearing as though they are within the acceptable shelf life. There is a possibility of hydrogel drying, which may result in poor electrical connection to the patient, which can reduce the energy delivered to the patient.
- Class II
Medical Device Recall · October 11, 2024
Hillrom Welch Allyn HScribe Holter System; ambulatory monitoringThere 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.
- Class II
Medical Device Recall · October 11, 2024
Ortho-Clinical Diagnostics, Inc.
VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP) concentration in serum and plasma Model/Catalog Number: 1926740May Generate Negatively Biased Results When Testing Samples with High Concentrations of CRP, showing less than upper AMI of 90 mg/L (in the 70-90 mg/L range) while the samples having higher than 90 mg/L. User no way to know if the sample has to be diluted to measure again.
- Class II
Medical Device Recall · October 11, 2024
Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System; cardiac stress testThere 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.
- Class II
Medical Device Recall · October 11, 2024
Hillrom Welch Allyn XScribe Cardiac Stress Testing System; Programmable Diagnostic ComputerThere 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.
- Class II
Medical Device Recall · October 11, 2024
Hillrom Welch Allyn RScribe 12-Lead Electrocardiograph System; ElectrocardiographThere 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.
- Class II
Medical Device Recall · October 11, 2024
Hillrom Welch Allyn Diagnostic Cardiology Suite (formerly Connex Cardio); Diagnostic spirometerThere 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.
- Class II
Medical Device Recall · October 11, 2024
4.5 x 180 mm REF 28208BKS Aggressive Cutter, sterile, 6x 3.5 x 70 mm REF 28206CBS Full Radius Resector, sterile, 6x 5.5 x 120 mm REF 28205NDS Aggr. Pro Line Shaver Blade, sterile, 6x 5.5 x 12Due to holes detected in the inner barrier system that may compromise the sterility of the affected products.
- Class II
Medical Device Recall · October 11, 2024
Hillrom Welch Allyn Vision Express Holter Analysis System; ElectrocardiographThere 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.
- Class I
Medical Device Recall · October 10, 2024
Boston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number M004CRBS4000; CONSOLE REFURB: Material Number M004CRBS400R0; CONSOLE HOSPITAL, Material Number M004CRBS400H0, CONSOLE ZERO, MaBoston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
- Class I
Medical Device Recall · October 10, 2024
BioZorb Marker. Radiographic soft tissue marker.Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort.
- Class I
Medical Device Recall · October 10, 2024
Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
- Class I
Medical Device Recall · October 10, 2024
Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS2060Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
- Class I
Medical Device Recall · October 10, 2024
Boston Scientific POLARx FIT BALLOON CATHETER ST OUS, Material Number M004CRBS2010Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
- Class II
Medical Device Recall · October 10, 2024
Philips Medical Systems Technologies Ltd.
Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software Model Number: 1149418 Intended use is to provide completely scalable local and wide area PACS (Picture Archiving andA software issue affecting Philips Vue PACS may cause incorrect ischemic map and table value calculations when using the export function in the Perfusion Application for a Siemens CT perfusion study, resulting in misdiagnosis due to incorrect ischemic map and table values.
- Class I
Medical Device Recall · October 10, 2024
Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
- Class I
Medical Device Recall · October 10, 2024
Boston 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.
- Class I
Medical Device Recall · October 10, 2024
Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS2160Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
- Class II
Medical Device Recall · October 9, 2024
Imed Products Imed EVA BAG, 1000 mL, 2-PORTS, REF IM68055; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.A limited number of IV bags have been found to leak during filling.
- Class II
Medical Device Recall · October 9, 2024
Shimadzu Corp. Analytical & Measuring Instruments Div.
Autosampler, Models: SIL-20ACXR CL, SIL-20ACHT CL, SIL-30AC CLThere have been cases of failure of the main board due to condensation water drained from the Peltier dehumidifier, leaked out from the tray, resulting in a short circuit. In the serious case, the main board and adjacent cables are partly charred. In the minor case, the Y motor and its surrounding die cast part become rusty. These failures could result in delay in patient sample testing.
- Class II
Medical Device Recall · October 9, 2024
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE convenience kits labeled as: 1) VAGINAL, REF CDS984955M; 2) DAY SURG LARGE VAG CDS, REF CDS984995M; 3) MAJOR VAGINAL PACK-LF, REF DYNJ0826768P; 4) VAGINAL PACK, REF DYNJ59081C; 5)VAMedline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
- Class II
Medical Device Recall · October 9, 2024
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY-LF, REF CDS760059I; 2) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S; 3) GYN MAJOR, REF CDS980998L; 4) ROBOTIC PROCEDURE, REF CDS982128P;Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
- Class II
Medical Device Recall · October 9, 2024
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ0160598C; 2) BREAST BIOPSY PACK-LF, REF DYNJ0842590G; 3) TREATMENT ROOM PACK, REF DYNJ41473G; 4) TREATMENT ROOM PACK, RMedline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
- Class II
Medical Device Recall · October 9, 2024
SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed), REF 66041; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.A limited number of IV bags have been found to leak during filling.
- Class II
Medical Device Recall · October 9, 2024
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE convenience kits labeled as: 1) TRACH TOTE, REF DYNJ85691; 2) TRACHEOSTOMY, REF DYNJ902123JMedline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
- Class II
Medical Device Recall · October 9, 2024
CORMIX 150 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64040; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.A limited number of IV bags have been found to leak during filling.
- Class II
Medical Device Recall · October 9, 2024
SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports, REF 66042; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.A limited number of IV bags have been found to leak during filling.
- Class II
Medical Device Recall · October 9, 2024
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE medical convenience kits labeled as: 1) ACETABULAR PACK-LF, REF DYNJ0572894I; 2) LOCAL BASIC, REF DYNJ34418L; 3) LOCAL BASIC, REF DYNJ34418M; 4) MINI LOCAL, REF DYNJ900287DMedline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
- Class II
Medical Device Recall · October 9, 2024
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE convenience kits labeled as: 1) MAJOR LITHOTOMY CDS-LF, REF CDS760056G; 2) LAVH CDS, REF CDS983411J; 3) MAJOR VAGINAL, REF CDS983497L; 4) DAY SURG LARGE VAG CDS, REF CDS984995N; 5)Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.