Medical Device Recalls

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7,959 medical device recalls from federal enforcement feeds.

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Showing 4,651–4,700 of 7,959

Medical Device Recall · October 11, 2024
Baxter Healthcare Corporation
Hillrom 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.
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: 1926740
May 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
Baxter Healthcare Corporation
Hillrom 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.
Class II
Medical Device Recall · October 11, 2024
Baxter Healthcare Corporation
Hillrom 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.
Class II
Medical Device Recall · October 11, 2024
Baxter Healthcare Corporation
Hillrom 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.
Class II
Medical Device Recall · October 11, 2024
Baxter Healthcare Corporation
Hillrom 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.
Class II
Medical Device Recall · October 11, 2024
Baxter Healthcare Corporation
Hillrom 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.
Class II
Medical Device Recall · October 10, 2024
Boston Scientific Corporation
Boston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number M004CRBS4000; CONSOLE REFURB: Material Number M004CRBS400R0; CONSOLE HOSPITAL, Material Number M004CRBS400H0, CONSOLE ZERO, Ma
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 Corporation
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
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 and
A 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 II
Medical Device Recall · October 10, 2024
Boston Scientific Corporation
Boston 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.
Class I
Medical Device Recall · October 10, 2024
Boston Scientific Corporation
Boston 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.
Class I
Medical Device Recall · October 10, 2024
Boston Scientific Corporation
Boston 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.
Class I
Medical Device Recall · October 10, 2024
Boston Scientific Corporation
Boston 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.
Class I
Medical Device Recall · October 10, 2024
Hologic, Inc
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 Corporation
Boston 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.
Class I
Medical Device Recall · October 9, 2024
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE convenience kits labeled as: 1) ANGIO PACK #2, REFDYNJ39185D; 2) CV MINOR CATH LAB PACK, REFDYNJ44997J; 3) PLASTIC PACK, REFDYNJ58409C; 4) GENDER AFFIRMING SURGERY, REFDYNJ66252A; 5
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) 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) TRACH TOTE, REF DYNJ85691; 2) TRACHEOSTOMY, REF DYNJ902123J
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
The Metrix Company
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 CL
There 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
The Metrix Company
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 convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202P; 2) BASIC NEURO PACK, REF CDS780202Q; 3) BASIC NEURO PACK, REF CDS780202R; 4) ACDF CDS, REF CDS941061M; 5) NEURO KIT
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
The Metrix Company
Imed Products Imed EVA BAG, 250 mL, 2-PORTS, REF IM68045; 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
The Metrix Company
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
The Metrix Company
SECURE 1000 mL EMPTY EVA CONTAINER With 2 Ports, REF 66055; 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-40C XR CL, SIL-40C X3 CL
There have been cases of failure of the main board due to condensation water occurring in the gap between thermal insulation material on the underside of the main base dropping onto the main board The symptoms and errors differ depending on the position where the water drops adhere. To date there have been examples of reports of inter-board communication errors, HOME POSITION error or SLIP error of XYZ drive units. The failure could result in delay of patient sample testing.
Class II
Medical Device Recall · October 9, 2024
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE convenience kits labeled as: L&D MINOR PACK, REF DYNJ82672
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: COLON WOUND CLOSURE PACK, REF DYNJ52141B
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
The Metrix Company
SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports, REF 66040; 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: 2) ABDOMINAL LAPAROSCOPY, REF CDS760057K; 3) ABDOMINAL LAPAROSCOPY, REF CDS760057L; 4) MAJOR LAPAROTOMY CDS, REF CDS860015W; 5) MINOR LAPAROTOMY CDS, REF CDS8
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) MINOR EYE TRAY #81, REF DYNJ27466S; 2) EYE PACK, REF DYNJ41207C; 3) CATARACT PACK, REF DYNJ43147G; 4) OSC OCULOPLASTIC PACK, REF DYNJ63329D; 5) OSC O
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, R
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
The Metrix Company
SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed) , REF 66043; 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) CIRCUMCISION PACK, REF DYNJ16826O; 2) D-CIRCUMCISION PACK, REF DYNJ64432; 3) PACK,CIRCUMCISION ASC, REF DYNJ906909A
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
The Metrix Company
VYGON 250 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9602; 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) GENERAL ENDOSCOPY PACK, REF DYNJ44673G; 2) ENDO BLADDER PACK, REF DYNJ49672L
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
The Metrix Company
CORMIX 250 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64045; 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
The Metrix Company
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
The Metrix Company
Imed Products Imed EVA BAG, 500 mL, 2-PORTS, REF IM68050; 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
The Metrix Company
SECURE 500 mL EMPTY EVA CONTAINER With 2 Ports, REF 66050; 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
Refer to RES or lead review memo for complete list of affected reference/catalog numbers
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
The Metrix Company
VYGON 100 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9601; 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) ORTHO LAMINECTOMY-LF, REF CDS780112J; 2) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V; 3) BASIC BACK CDS, REF CDS780147N; 4) INSTRUMENTED BACK CDS, REF CDS7
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: PORT INSERTION PACK, REF DYNJ81597
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 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 DYNJ900287D
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
The Metrix Company
Imed Products Imed EVA BAG, 150 mL, 2-PORTS, REF IM38040; 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) LAKELAND SINGLE BASIN PACK-LF, REF DYNJ0619907I; 2) LAKELAND SINGLE BASIN PACK-LF, REF DYNJ0619907K; 3) LKLND SNGL BASIN PK RFID-LF, REF DYNJ0619907L;
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
The Metrix Company
SECURE 250 mL EMPTY EVA CONTAINER With 2 Ports, REF 66045; 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) C-SECTION OR 30 CDS, REF CDS820075V; 2) C-SECTION OR 30 CDS, REF CDS820075W; 3) C-SECTION, REF CDS980774M; 4) C-SECTION KIT, REF CDS981322AB; 5) C-SECTION
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Class II