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Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

37,779 Total Recalls

MIC* Gastric-Jejunal Feeding Tube, Endoscopic/Radiologic Placement, GJ-Tube: a) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 16 Fr, Product Code 0250-16; b) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 16 Fr, Product Code 0250-16-15; c) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 16 Fr, Product Code 0250-16-22; d) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 16 Fr, Product Code 0250-16-30; e) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 18 Fr, Product Code 0250-18; f) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 18 Fr, Product Code 0250-18-22; g) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 18 Fr, Product Code 0250-18-30; h) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 22 Fr, Product Code 0250-22; i) MIC* Gastric-Jejunal Feeding Tube Kit - Surgical Placement - 16 Fr, Product Code 0260-16; j) MIC* Gastric-Jejunal Feeding Tube Kit - Surgical Placement - 18 Fr, Product Code 0260-18; k) MIC* Gastric-Jejunal Feeding Tube Kit - Surgical Placement - 22 Fr, Product Code 0260-22;

Avanos Medical

Class I - Dangerous

MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist.

Jan 16, 2024 Surgical Instruments Nationwide View Details →

VITROS XT 7600 Integrated System, Catalog No. 6844461

Ortho-Clinical Diagnostics

Class I - Dangerous

A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met. This may result in acceptance of QC results that do not meet acceptance criteria, which may cause erroneous patient results to be reported.

Jan 26, 2024 Other Medical Devices Nationwide View Details →

Vantage Titan, Model: MRT-1504

Canon Medical System, USA

Class I - Dangerous

For some MRI systems, it has been found that some of the maximum Spatial Field Gradient (SFG) values displayed in "System Information" of the operation window and some of the maximum SFG values described in the safety manual are lower than the correct values, which may cause a patient with an MR conditional device to feel some discomfort during the MR scan.

Jan 29, 2024 Other Medical Devices Nationwide View Details →

Synapse PACS - Version 7.3.000

FUJIFILM Healthcare Americas

Class I - Dangerous

Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.

Jan 10, 2024 Other Medical Devices Nationwide View Details →

VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)

Ortho-Clinical Diagnostics

Class I - Dangerous

A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met. This may result in acceptance of QC results that do not meet acceptance criteria, which may cause erroneous patient results to be reported.

Jan 26, 2024 Other Medical Devices Nationwide View Details →

The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter designed for the infusion of the Onyx liquid embolic system (LES). The catheter has a semi-rigid proximal shaft and a highly flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The proximal end of the catheter incorporates a standard Luer adapter to facilitate the attachment of accessories. The outer diameter surface of the catheter is hydrophilically coated to increase lubricity. The AOMC is designed to facilitate catheter retrieval in the event the catheter becomes entrapped within the vasculature. The distal section of the catheter incorporates a detachment zone that allows detachment of the distal tip when the force required to extract the catheter exceeds the force to detach the tip. The catheter has two radiopaque marker bands to visualize the position of the catheter and the detach zone area, one proximal to the detach zone and one at the distal end of the catheter.

Micro Therapeutics

Class I - Dangerous

European version of microcatheter were distributed within US which contain a different "Indications for Use".

Jan 11, 2024 Diagnostic Equipment Nationwide View Details →

RIA Tube Assembly, minimum 520 mm length, sterile- intended for use in adults and adolescents (12-21 years) to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis, to harvest finely morselized autogenous bone and bone marrow for any surgical procedure requiring bone graft to facilitate fusion and/or fill bone defects, and to remove infected and necrotic bone and tissue from the medullary canal in the treatment of osteomyelitis. Part Number: 314.746S

Synthes (USA) Products

Class I - Dangerous

Products not sterilized, sterility cannot be confirmed

Jan 24, 2024 Implants & Prosthetics Nationwide View Details →

Synapse PACS - Version 7.2.200

FUJIFILM Healthcare Americas

Class I - Dangerous

Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.

Jan 10, 2024 Other Medical Devices Nationwide View Details →

VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)

Ortho-Clinical Diagnostics

Class I - Dangerous

A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met. This may result in acceptance of QC results that do not meet acceptance criteria, which may cause erroneous patient results to be reported.

Jan 26, 2024 Other Medical Devices Nationwide View Details →