Medical Device Recalls

7,959 medical device recalls from federal enforcement feeds.

Showing 3,701–3,750 of 7,959

• Medical Device Recall · February 25, 2025

  Baxter Healthcare Corporation

  Baxter TruSystem 7500 Hybrid (MC), Product Code 1773204

  There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.

  Class II

• Medical Device Recall · February 25, 2025

  Baxter Healthcare Corporation

  Baxter TruSystem 7500 Hybrid (SC), Product Code 1854086

  There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.

  Class II

• Medical Device Recall · February 25, 2025

  Stryker Corporation

  Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Number 5400-222-004S

  There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.

  Class II

• Medical Device Recall · February 25, 2025

  Stryker Corporation

  Nasopore 8cm fragmentable nasal dressing, Firm Catalog Number 5400-020-008 and Forte Catalog Number 5400-020-008ITL

  There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.

  Class II

• Medical Device Recall · February 25, 2025

  Stryker Corporation

  Nasopore Ex Firm 4cm fragmentable nasal dressing, Catalog Number 5400-030-004 and Nasopore Forte plus 4cm Catalog Number 5400-030-004ITL

  There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.

  Class II

• Medical Device Recall · February 25, 2025

  Stryker Corporation

  Nasopore Ex Firm 8cm fragmentable nasal dressing, Catalog Number 5400-030-008 and Nasopore Forte plus 8cm Catalog Number 5400-030-008ITL

  There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.

  Class II

• Medical Device Recall · February 25, 2025

  Stryker Corporation

  Nasopore 4cm fragmentable nasal dressing, Firm Catalog Number 5400-020-004 and Forte Catalog Number 5400-020-004ITL

  There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.

  Class II

• Medical Device Recall · February 24, 2025

  Checkpoint Surgical Inc

  Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intraoperative Lead, Small Model/Catalog Number: REF# 9524 (Small) Product Description: The Checkpoint Guardian

  Adhesive on the back of the lead may not fully encapsulate the metallic portion of the wire and button subassembly, potentially leading to exposed metal. There is a risk of electrical current leakage, which may lead to inconsistent or confusing muscle responses, potentially compromising the effectiveness of the intended use as the surgeon could take an incorrect clinical action.

  Class II

• Medical Device Recall · February 24, 2025

  Checkpoint Surgical Inc

  Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intraoperative Lead, Medium Model/Catalog Number: REF# 9525 (Medium) Product Description: The Checkpoint Guardi

  Adhesive on the back of the lead may not fully encapsulate the metallic portion of the wire and button subassembly, potentially leading to exposed metal. There is a risk of electrical current leakage, which may lead to inconsistent or confusing muscle responses, potentially compromising the effectiveness of the intended use as the surgeon could take an incorrect clinical action.

  Class II

• Medical Device Recall · February 24, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Medline medical convenience kits labeled as: 1) NEONATAL INTUBATION TRAY, REF ACC010371C; 2) NEWBORN RESUSCITATION KIT, REF ACC010381A; 3) NEWBORN RESUSCITATION KIT, REF ACC010381B; 4) NEWBOR

  Specific Medline Kits were manufactured using Intubation ORAL/NASAL Endotracheal Tubes which were subsequently recalled by Smiths Medical.

  Class I

• Medical Device Recall · February 24, 2025

  DePuy Mitek, Inc., a Johnson & Johnson Co.

  COR Disposable Kit, 8 mm w/ Perpendicularity. Cartilage Transplant System.

  Device is missing the pin in the graft loader component.

  Class II

• Medical Device Recall · February 24, 2025

  DePuy Mitek, Inc., a Johnson & Johnson Co.

  COR Disposable Kit, 8 mm. Cartilage Transplant System.

  Device is missing the pin in the graft loader component.

  Class II

• Medical Device Recall · February 24, 2025

  PYRAMES INC

  Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007

  Single-use battery-powered blood pressure monitor, for use on neonates and infants, due to vibratory noise, may not adequately detect changes in blood pressure per specification. Containment actions: 1) Ventilator lines not to touch the isolette (e.g. mattress, side rails, pillow) or patient, 2) Move affected monitor to patient's foot.

  Class II

• Medical Device Recall · February 21, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CPB ADJUNCT PACK, DR. C PACK, PK CUST CV A&B C CO, TOL DR R PACK, TOL DR. C PACK, TOL DR. M PACK.

  Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the potential excess material in the male lures on the aortic cannula.

  Class I

• Medical Device Recall · February 21, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CABG OPNHRT S HSP, CARDIAC CABG, CARDIAC PACK, DR D AC PACK, HEART BASIN PACK-LF, K OH COMPONENT PACK,

  Medline medical procedure kits, containing Medtronic Aortic Root Cannula

  Class I

• Medical Device Recall · February 21, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: HEART BASIN PACK-LF

  Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the potential excess material in the male lures on the aortic cannula.

  Class I

• Medical Device Recall · February 21, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: TOL DR R PACK

  Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the potential excess material in the male lures on the aortic cannula.

  Class I

• Medical Device Recall · February 20, 2025

  Orthofix U.S. LLC

  Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant grade titanium alloy: (1) REF 82-3300SP, 33mm W x 24mm D x 10mm H, 7 degrees; (2) REF 82-3700SP, 37mm

  The product is mislabeled with the incorrect anterior height of 10mm, but the laser marking on the implant and corresponding trial both show the correct anterior height of 10.5mm.

  Class II

• Medical Device Recall · February 20, 2025

  Microbiologics Inc

  Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0065N

  The A549 human cell target (human cells for sample adequacy control) may give a late Ct value.

  Class II

• Medical Device Recall · February 20, 2025

  Microbiologics Inc

  Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control material, Catalog Number HE0044N

  The RSV target may give a late Ct value and could potentially not pass QC.

  Class II

• Medical Device Recall · February 20, 2025

  Omnicell, Inc.

  IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: 1 set per White Tyvek Pouch, 5 Tyvek Pouches per shelf box, 10 shelf boxes per case box. IVX Station Reconstitution Tran

  IVX Station Reconstitution Transfer Sets were shipped in advance of the IVX Station upgrade and not intended for clinical use but are engineering devices intended for use during set up and system calibration. The items were not shipped in a validated packing configuration and sterility cannot be ensured.

  Class II

• Medical Device Recall · February 20, 2025

  BD SWITZERLAND SARL

  BD Connecta BD Luer-Lok 360, REF 394910 UDI-DI code: 00382903949106 Connecta¿ Plus 1 and Connecta¿ Plus 3 2-way and 3-way Stopcocks are control valves for use in IV. therapy and hemodynamic pressu

  Due to specific lots of luer-lok devices were shipped to the U.S. market with an Outside US Instruction for Use (IFU)

  Class II

• Medical Device Recall · February 19, 2025

  Calyxo, Inc.

  CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended for endoscopic examination/treatment of urinary tract and kidney interior.

  Aspiration system, for endoscopic examination/treatment of urinary tract and kidney interior, to have labeling update adding additional instructions, for patients with high viscosity fluid in the kidney, not to continue providing fluid inflow in the presence of unresolved slow or absent fluid outflow because this can create intrarenal pressure imbalance, and lead to excessive intrarenal pressure.

  Class I

• Medical Device Recall · February 19, 2025

  Merge Healthcare, Inc.

  VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9.0.6 and 9.0.8; VERICIS is an integrated cardiovascular information system classified as a picture archiving and communica

  When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, derived measurements may be inconsistent with the associated primitive measurements in the final patient report.

  Class II

• Medical Device Recall · February 19, 2025

  GE Healthcare

  GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 2033901-001; 2) 2038437-001; 3) 2038437-009; 4) 2038437-014; 5) 2038437-015 ; 6) 2038437-0XX; 7) 2109571-007; 8)

  There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.

  Class II

• Medical Device Recall · February 19, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Wayson Hydrocolloid Models: 1) MJ BANDAGE HYDROCOLLOID HEEL OVAL 6CT, Model Number: MJ18004V2; 2) MJ BANDAGE HYDROCOLLOID ALL PURP 10CT, Model Number: MJ18005V2; 3) MJ BNDG HYDROCOLLOID FINGER TO

  There is a potential for the sterility of the device to be compromised.

  Class II

• Medical Device Recall · February 19, 2025

  Flux Technology Inc.

  Lazervida 10W diode laser cutter and engraver with Lazervida shield.

  Lazervida 10W Diode Laser Engraver does not fully meet current Federal performance standards in certain areas. Specifically, the product does not incorporate the additional beam attenuator, remote interlock connector, key switch, specific labels and manual instructions required under current regulations.

  Class II

• Medical Device Recall · February 19, 2025

  GE Healthcare

  GE Healthcare Centricity Radiology RA600 (RA600), Model Numbers: 1) 2022296-001; 2) 2033901-001; 3) 2038437-001; 4) 2038437-011; 5) 2038437-012; 6) 2038437-013; 7) 2038437-014; 8) 203

  There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.

  Class II

• Medical Device Recall · February 19, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Wayson Hydrocolloid Models: 1) Model Number: CUR5103, DBD-BNDG,WTRPRF,HYDRCLLD,CLR,2.36X3.93", 2) Model Number: MJ18004, DBD-MEIJER,BANDAGE,HYDROCOLLOID,HEEL,OVL 3) Model Number: MJ18005, MEIJER,BA

  There is a potential for the sterility of the device to be compromised.

  Class II

• Medical Device Recall · February 19, 2025

  GE Healthcare

  GE Healthcare Centricity Universal Viewer (UV), Model Numbers: 1) 2066908-077; 2) 2066908-136; 3) 2066908-150; 4) 2088026-003; 5) 2088026-026; 6) 2088026-032; 7) 2088026-043; 8) 2088026-

  There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.

  Class II

• Medical Device Recall · February 19, 2025

  GE Healthcare

  GE Healthcare Centricity PACS-IW (PACS-IW), Model Numbers: 1) 2042988-001; 2) 2049587-009; 3) 2049587-011; 4) 2049587-012; 5) 2049587-015; 6) 2049588-012 ; 7) 2052829-001.

  There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.

  Class II

• Medical Device Recall · February 19, 2025

  Merge Healthcare, Inc.

  VERICIS, Merge Cardio, Model/Catalog Number: Version 11.x, Software Version: 11.0.2, 11.0.3, 11.0.4, 11.1, 11.1.1; The VERICIS is an integrated cardiovascular information system classified as a pictur

  When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, derived measurements may be inconsistent with the associated primitive measurements in the final patient report.

  Class II

• Medical Device Recall · February 19, 2025

  GE Healthcare

  GE Healthcare Centricity Centricity PACS-IW with Universal Viewer, Model Numbers: 1) 2049587-015; 2) 2066908-086; 3) 2066908-136; 4) 2104867-045.

  There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.

  Class II

• Medical Device Recall · February 19, 2025

  Merge Healthcare, Inc.

  VERICIS, Merge Cardio, Model/Catalog Number: Version 10.x, Software Version: 10.0, 10.1.1.1, 10.1.2, 10.2.0, 10.2 P2 , 10.3; The VERICIS is an integrated cardiovascular information system classified a

  When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, derived measurements may be inconsistent with the associated primitive measurements in the final patient report.

  Class II

• Medical Device Recall · February 19, 2025

  Merge Healthcare, Inc.

  Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.1, 12.1.1, 12.2, 12.3, 12.3.1, 12.3.2, 12.3.3, 12.4, 12.4.1, 12.4.2; Merge Cardio is a software medical device that is an integra

  When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, derived measurements may be inconsistent with the associated primitive measurements in the final patient report.

  Class II

• Medical Device Recall · February 19, 2025

  Merge Healthcare, Inc.

  VERICIS, Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.0.1, 12.0.2; The VERICIS is an integrated cardiovascular information system classified as a picture archiving and commun

  When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, derived measurements may be inconsistent with the associated primitive measurements in the final patient report.

  Class II

• Medical Device Recall · February 19, 2025

  MIM Software Inc

  MIM software; System, Image Processing, Radiological

  In situations where two images with differing Fields of View (FOV) complete an image fusion, an incorrect, elevated Maximum Standardized Uptake Value (SUV) within MIM Software versions 7.2.0 through 7.2.6.could result.

  Class II

• Medical Device Recall · February 18, 2025

  CareFusion 303, Inc.

  BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software

  Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).

  Class I

• Medical Device Recall · February 18, 2025

  CareFusion 303, Inc.

  BD Care Coordination Engine (CCE) Infusion Adapter, Safety Management Software

  Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).

  Class I

• Medical Device Recall · February 18, 2025

  GE Medical Systems, LLC

  GE Healthcare Revolution Apex Expert, System, X-ray, Tomography, Computed

  GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls.

  Class II

• Medical Device Recall · February 18, 2025

  GE Medical Systems, LLC

  GE Healthcare Revolution Apex Plus, System, X-ray, Tomography, Computed

  GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls.

  Class II

• Medical Device Recall · February 18, 2025

  GE Medical Systems, LLC

  GE Healthcare Revolution Apex Elite, System, X-ray, Tomography, Computed

  GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls.

  Class II

• Medical Device Recall · February 18, 2025

  GE Medical Systems, LLC

  GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed

  GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls.

  Class II

• Medical Device Recall · February 18, 2025

  GE Medical Systems, LLC

  GE Healthcare Revolution Apex Select, System, X-ray, Tomography, Computed

  GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls.

  Class II

• Medical Device Recall · February 18, 2025

  GE Medical Systems, LLC

  GE Healthcare Revolution CT, System, X-ray, Tomography, Computed

  GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls.

  Class II

• Medical Device Recall · February 18, 2025

  GE Medical Systems, LLC

  GE Healthcare Revolution CT ES, System, X-ray, Tomography, Computed

  GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls.

  Class II

• Medical Device Recall · February 17, 2025

  Oridion Medical 1987 Ltd.

  Microstream Instructions for Use and Part Number used with - Product Description, REF: Filter Line Sets Adult/Pediatric & Infant/Neonatal, 10129497 - CapnoLine Neonatal-Infant Intubated Filter

  Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. suctioning), may cause treatment delay and/or unintended extubation, which could lead to respiratory failure, hypoxia, aspiration, and/or low oxygen saturation.

  Class II

• Medical Device Recall · February 17, 2025

  DAYE (ANNE'S DAY LTD)

  Initiation 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-MM-IB18180000;

  Product lacks 510(k) clearance.

  Class II

• Medical Device Recall · February 17, 2025

  DAYE (ANNE'S DAY LTD)

  Initiation 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-IB18001800;

  Product lacks 510(k) clearance.

  Class II

• Medical Device Recall · February 17, 2025

  DAYE (ANNE'S DAY LTD)

  18 Coated Regular Tampons; Model Number: FG-TMP-REF18000000;

  Product lacks 510(k) clearance.

  Class II