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  1. FDA Recalls
  2. ›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 4761–4780 of 39,430 recalls

Class IIOngoing

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.)

Defibtech, LLC

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

October 14, 2024 · DeviceView details →
Class IIOngoing

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)

Defibtech, LLC

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.

October 14, 2024 · DeviceView details →
Class IIOngoing

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 sudden cardiac arrest (SCA.)

Defibtech, LLC

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

October 14, 2024 · DeviceView details →
Class IIOngoing

Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789

Cook Incorporated

Devices from the affected device lots have labels that state the incorrect expiration dates.

October 14, 2024 · DeviceView details →
Class IIOngoing

Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph

Baxter Healthcare Corporation

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.

October 11, 2024 · DeviceView details →
Class IIOngoing

Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System; cardiac stress test

Baxter Healthcare Corporation

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.

October 11, 2024 · DeviceView details →
Class IIOngoing

Hillrom Welch Allyn Diagnostic Cardiology Suite (formerly Connex Cardio); Diagnostic spirometer

Baxter Healthcare Corporation

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.

October 11, 2024 · DeviceView details →
Class IIOngoing

Hillrom Welch Allyn RScribe 12-Lead Electrocardiograph System; Electrocardiograph

Baxter Healthcare Corporation

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.

October 11, 2024 · DeviceView details →
Class IIOngoing

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 120 mm REF 20205FDS Round Burr, sterile, 6x 6.5 x 120 mm REF 28205HES, Aggressive Barrel Burr, sterile, 6x 4.2 x 120 mm REF 28205GDS Finish Barrel Burr, sterile, 6x 5.5 x 180 mm REF 28208IDS Semi Hooded Barrel Burr, sterile, 6x 5.5 x 120 mm REF 28205HDS Aggressive Barrel Burr, sterile, 6x

Karl Storz Endoscopy

Due to holes detected in the inner barrier system that may compromise the sterility of the affected products.

October 11, 2024 · DeviceView details →
Class IIOngoing

VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP) concentration in serum and plasma Model/Catalog Number: 1926740

Ortho-Clinical Diagnostics, Inc.

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.

October 11, 2024 · DeviceView details →
Class IIOngoing

Hillrom Welch Allyn HScribe Holter System; ambulatory monitoring

Baxter Healthcare Corporation

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.

October 11, 2024 · DeviceView details →
Class IIOngoing

Hillrom Welch Allyn XScribe Cardiac Stress Testing System; Programmable Diagnostic Computer

Baxter Healthcare Corporation

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.

October 11, 2024 · DeviceView details →
Class IOngoing

Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100

Boston Scientific Corporation

Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.

October 10, 2024 · DeviceView details →
Class IOngoing

Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS2060

Boston Scientific Corporation

Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.

October 10, 2024 · DeviceView details →
Class IOngoing

BioZorb Marker. Radiographic soft tissue marker.

Hologic, Inc

Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort.

October 10, 2024 · DeviceView details →
Class IOngoing

Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS2160

Boston Scientific Corporation

Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.

October 10, 2024 · DeviceView details →
Class IOngoing

Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110

Boston Scientific Corporation

Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.

October 10, 2024 · DeviceView details →
Class IOngoing

Boston 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 Corporation

Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.

October 10, 2024 · DeviceView details →
Class IOngoing

Boston Scientific POLARx FIT BALLOON CATHETER ST OUS, Material Number M004CRBS2010

Boston Scientific Corporation

Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.

October 10, 2024 · DeviceView details →
Class IOngoing

Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000.

Boston Scientific Corporation

Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.

October 10, 2024 · DeviceView details →
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