Medical Device Recalls
RSS ↗8,689 medical device recalls from federal enforcement feeds.
Showing 4,601–4,650 of 8,689
- Class II
Medical Device Recall · February 6, 2025
BORN ON ARRIVAL KIT , Model No LLBN11BACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- Class II
Medical Device Recall · February 6, 2025
C-SECTION PACK, Model Nos LLCS44F LLCS44F-01ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- Class II
Medical Device Recall · February 6, 2025
THORACIC PACK , Model No UTTC82Y UTTC82AA-01ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- Class II
Medical Device Recall · February 6, 2025
URO ROBOTIC PACK , Model No LVUR44C LVUR44C-03ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- Class II
Medical Device Recall · February 6, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline Item Numbers: 401582R, 401904R, 401904R, 401905R, 401933R, and 401991RDevices may have higher than expected amounts of bacterial endotoxin.
- Class II
Medical Device Recall · February 6, 2025
CENTRAL LINE PICC , Model No LLCL44H LLCL44H-01ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- Class II
Medical Device Recall · February 6, 2025
DELIVERY PACK , Model No SGDV22D-01 SGDV22EACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- Class II
Medical Device Recall · February 6, 2025
OPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01IACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- Class II
Medical Device Recall · February 6, 2025
OPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- Class II
Medical Device Recall · February 6, 2025
CV BASIC PUMP PACK , Model No WECV23DACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- Class II
Medical Device Recall · February 6, 2025
HIP SCOPE, Model Nos. CCHS21B CCHS21B-01 CCHS21B-02ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- Class II
Medical Device Recall · February 6, 2025
MAJOR VASCULAR PACK , Model No UTMV78X-01 UTMV78Y UTMV78Y-01 UTMV78X-01 UTMV78Y-02ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- Class II
Medical Device Recall · February 6, 2025
LAPAROSCOPY PACK , Model No SFLA02A SFLA02BACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- Class II
Medical Device Recall · February 6, 2025
GENERAL LAPAROSCOPIC PACK-LF , Model No UTGL53S-06 UTGL53S-07 UTGL53S-08ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- Class II
Medical Device Recall · February 6, 2025
CYSTO , Model No SACY80RACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- Class II
Medical Device Recall · February 6, 2025
DR DIULUS INJECTION PACK, Model Nos. CCDU12C CCDU12D CCDU12D-01ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- Class II
Medical Device Recall · February 6, 2025
LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07BACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- Class II
Medical Device Recall · February 6, 2025
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278Beckman Coulter identified that an issue for DxI 9000 tip stocker interface (TSI) and reagent storage interface (RSI) boards with the firmware version 1.1.0.0 can cause sub-system communication failures. This failure could result in a delay in reporting patient results.
- Class II
Medical Device Recall · February 6, 2025
DIAGNOSTIC NEURO IR TRAY , Model No WENE21ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- Class II
Medical Device Recall · February 6, 2025
LABOR & DELIVERY PPS , Model No LLLD64O LLLD64O-01 LLLD64O-02ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- Class II
Medical Device Recall · February 6, 2025
MAJOR DIEP, Model Nos. CCMJ73G-01 CCMJ73HACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- Class II
Medical Device Recall · February 6, 2025
SPINE LUMBAR PACK , Model No UTSL72AA UTSL72ABACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- Class II
Medical Device Recall · February 6, 2025
NEURO IR TRAY , Model No WENI56JACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- Class I
Medical Device Recall · February 5, 2025
Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F x 85 cm, REF: 80238; S 8 F x 110 cm, REF: 80239Atherectomy Catheter eIFU updated to clarify and emphasize procedural steps intended to reduce the likelihood of catheter breakage events. Catheter has an outer cylinder connected to a rotating helix, which could fracture and/or break, which would require retrieval, and helix facture/break could cause vessel injury and lead to severe bleeding.
- Class II
Medical Device Recall · February 5, 2025
INTELERAD MEDICAL SYSTEMS INCORPORATED
IntelePACS (Image Fusion Module) - InteleViewerA software application that receives digital images and data from various sources has a bug in specific software versions that will calculate the Standard Uptake Value (SUV) incorrectly for PET/CT studies acquired on the days of Daylight Savings Time (DST); only on dates in which DST transition occurs; all other dates are unaffected. An incorrect SUV may lead to an incorrect diagnosis.
- Class II
Medical Device Recall · February 5, 2025
Medical Information Technology, Inc.
MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN). Calculator/data processing module for clinical use.Entering multiple keys that trigger input simultaneously may remove data from first field of screens and/or questionnaires with more than one field.
- Class I
Medical Device Recall · February 5, 2025
Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 B. CANNULA 11014 AR FLOWGUARD 14GA, model no. 11014 2. MiAR Cannula: A. CANNULA 11012L AR FLUnexpected loose material in the male luer used in the aortic root cannula has been identified. Potential harms when identified prior to use - procedure delay. Potential harm if not identified and used - stroke (reversible and irreversible).
- Class I
Medical Device Recall · February 5, 2025
Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAXThere is the potential for missing motor mounting screws, which may have occurred during the servicing process.
- Class I
Medical Device Recall · February 5, 2025
Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009There is the potential for missing motor mounting screws, which may have occurred during the servicing process.
- Class II
Medical Device Recall · February 5, 2025
Access 2 Immunoassay Analyzer, Catalog Number 81600NBeckman Coulter identified that an issue for Access 2 Sample Motors (B48016) due to improper alignment, causing the motors to rub against the sample wheelbase plate and index sensor. The issue was traced to a worn tool used in production (at the supplier), affecting Access 2 sample motors. This could lead to a potential delay in reporting patient test results.
- Class II
Medical Device Recall · February 5, 2025
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.the DxI 9000 encoder wheel was misaligned on the motor shaft, leading to increased slippage errors and causing the instrument to stop, posing a high safety risk due to potential delays in patient results.
- Class II
Medical Device Recall · February 4, 2025
IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60;Product is mislabeled with the incorrect fill volume.
- Class II
Medical Device Recall · February 4, 2025
CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.During an internal investigation, ACS was unable to confirm that the CODMAN component achieved the required Sterility Assurance Level and therefore is not suitable for sterilization according to ACS procedures.
- Class II
Medical Device Recall · February 3, 2025
LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest.Incorrect keypad was incorrectly installed onto a defibrillator/monitor.
- Class II
Medical Device Recall · February 3, 2025
HemosIL LMW Heparin Controls; Part Number: 0020300200;Multiple complaints indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range when testing is performed with HemosIL Liquid Anti-Xa and HemosIL Heparin Calibrator. In some complaints, failure to pass QC resulted in patient testing delays.
- Class I
Medical Device Recall · February 3, 2025
VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English), REF: PRT-00490-001; V+Pro (V+Pro, English), REF: PRT-01185-000, PRT-01185-002Multi-Function Ventilators were serviced using incorrect parts which have the potential to cause unexpected shutdown, or when using an active circuit could result in inaccurate tidal volume monitor, not triggering on patient efforts, less inspiratory volume, less inspiratory pressure, and less PEEP delivered.
- Class II
Medical Device Recall · February 3, 2025
CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 -CardioMEMS Backend Web Application Model CM4000 -Merlin.net Patient Care Network (PCN) Heart FailureDue to issues associated with data migration of patient information and results to a Cloud service, the firm has received complaint associated with some patient profile information being duplicated while other patient information is missing.
- Class II
Medical Device Recall · February 3, 2025
Access Erythropoietin (EPO), Catalog Number - A16364 a glycoprotein (~30,400 Daltons) produced primarily by the kidney, is the principal factor regulating red blood cell production (erythropoiesis)Affected lot (439363) exhibited a negative dose drop of -22% with native patient samples compared to alternate reagent lots. Patient samples tested with the affected lot may demonstrate repeatable falsely decreased results, which may lead to improper diagnosis or repeat testing.
- Class II
Medical Device Recall · February 3, 2025
Brand Name: TBS Osteo Product Name: TBS iNsight Model/Catalog Number: TBS iNsight v3.x / pn: OS-TBSi Software Version: V3.x: (1) V3.1.2, (2) V3.1.1, (3) V3.1.0, (4)V3.0.0 Product Description: TBSPotential variability in calculations from fast array scans compared to array scans when operating on Hologic Horizon machines.
- Class II
Medical Device Recall · January 31, 2025
American Contract Systems, Inc.
Brand Name: Banner Health Systems Product Name: Lap Pack - 170307 Model/Catalog Number: BHLP62H Software Version: N/A Product Description: Convenience Kit Component: NoSterility assurance with procedure trays
- Class II
Medical Device Recall · January 31, 2025
DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tubing, Suction, Connector; DeRoyal REF 71-C7100NS Tubing, Suction, Connector Indicated use - Fluid MovementDue to the inner diameter of the suction tubing connector being smaller than the suction canister lid port connection. This size difference, combined with the durometer of the plastic material, makes the assembly to a suction canister lid port difficult. This could result in inadequate suction and cause a delay in patient care.
- Class II
Medical Device Recall · January 31, 2025
American Contract Systems, Inc.
Brand Name: Banner University Med Ctr. Product Name: Cardiac Cath Lab Pack-170278 Model/Catalog Number: GSCC40G Software Version: N/A Product Description: Convenience Kit Component: NoSterility assurance with procedure trays
- Class II
Medical Device Recall · January 31, 2025
American Contract Systems, Inc.
Brand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Number: BHCY31E Product Description: Convenience Kit Component: NoSterility assurance with procedure trays
- Class II
Medical Device Recall · January 31, 2025
Paradigm REF: MMT-712 and MMT-715All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to changes in air pressure, which can be found during airplane take-off or landing. An unexpected additional dose of insulin, which can occur during take-off, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An unexpected under-delivery of insulin, which can occur during landing, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death. During a delivery accuracy dry run testing of the 780G NGP infusion pump under dynamic pressure conditions, the firm observed that when air pressure decreased during take-off simulation, on average 0.569U more insulin was delivered in 15 minutes than the expected delivery volume at ambient pressure at 1 U/hr delivery rate; when air pressure increased during landing simulation, on average 0.537 U less insulin was delivered in 25 minutes than the expected delivery volume at ambient pressure at 1 U/hr delivery rate. The firm also observed that the mechanisms causing the variations in delivery volumes are independent of the delivery rate.
- Class II
Medical Device Recall · January 31, 2025
MiniMed insulin pump, REF: 780G (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896)All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to changes in air pressure, which can be found during airplane take-off or landing. An unexpected additional dose of insulin, which can occur during take-off, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An unexpected under-delivery of insulin, which can occur during landing, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
- Class II
Medical Device Recall · January 31, 2025
MiniMed insulin pump, REF: 770G (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to changes in air pressure, which can be found during airplane take-off or landing. An unexpected additional dose of insulin, which can occur during take-off, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An unexpected under-delivery of insulin, which can occur during landing, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
- Class II
Medical Device Recall · January 31, 2025
Numerous models of nonsterile hemostatic forceps: (1) REF BH100R, Carrel Artery Forceps 85MM; (2) REF BH104R, Hartmann Mosquito FCSDEL STR 100MM; (3) REF BH105R, Hartmann Mosquito FCPSDELCVD100MM;The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
- Class II
Medical Device Recall · January 31, 2025
GE Healthcare (China) Co., Ltd.
SIGNA Creator, SIGNA Explorer, NMRI systemsFor certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display". The user interface may incorrectly enable a scan to proceed earlier than intended. If resumed by the operator, such a scan can result in potential excessive tissue heating, especially if the patient is in contact with a conductive material or has an implant.
- Class II
Medical Device Recall · January 31, 2025
GE Healthcare (China) Co., Ltd.
SIGNA MR380, NMRI system, Non-US OnlyFor certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display". The user interface may incorrectly enable a scan to proceed earlier than intended. If resumed by the operator, such a scan can result in potential excessive tissue heating, especially if the patient is in contact with a conductive material or has an implant.
- Class II
Medical Device Recall · January 31, 2025
MiniMed insulin pump, REF: 620G (MMT-1750)All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to changes in air pressure, which can be found during airplane take-off or landing. An unexpected additional dose of insulin, which can occur during take-off, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An unexpected under-delivery of insulin, which can occur during landing, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.