All recalls8,501 total
Ophthalmic Tissue Forceps (DEX") are sterile, hand-held ophthalmic surgical instruments designed for grasping, manipulating, compressing, pulling, or joining eye and/or surrounding tissues during surgical procedures. These devices fall under the GMDN code 62478 entitled Ophthalmic soft-tissue surgical forceps, probe-like, single use . Double pouched in tyvek pouches, sold in boxes of 5 with an inner and outer box.
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Affected lots are not performing to IFU criteria showing cross reactions with 2-0 within 60 seconds. Cross-reactivity may result in the misidentification of a Salmonella 9-O serotype as a 2-O serotype.
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Potential contamination with pesticides, haloxyfop and thiamethoxam
The potential contamination with Clostridium botulinum, due to risk of temperature abuse during chilled storage at the firm
Potential contamination with pesticides, haloxyfop and thiamethoxam
Potential contamination with pesticides, haloxyfop and thiamethoxam
Product may be contaminated with Salmonella.
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Potential Salmonella Contamination
The potential contamination with Clostridium botulinum, due to risk of temperature abuse during chilled storage at the firm
Presence of particulate matter
Failed Dissolution Specifications
Presence of particulate matter
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Products may report incorrect AST results during quality control. Health consequences may include delayed response or the need to change to another antifungal agent if laboratory ignores Quality Control test result.
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR.
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Through customer complaints, the ankle replacement system was found to contain incorrect devices: Left implant packaging and labeling bears a right implant device.
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak occurs during therapy this may result in therapy interruption with the potential for the patient to receive less infusion solution than intended. Exposure of hazardous substances to the patient, caregiver, or pharmacy technician is possible.
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Ingredients statement declares Anchovy and Sasame, but Contains statement does not declare Fish (Anchovy) and Sesame.
Undeclared allergen (soy lecithin).
Potential for detachment of a distal tip component of the device during use.
Potential for detachment of a distal tip component of the device during use.
Potential for detachment of a distal tip component of the device during use.
It was identified that certain devices were being operated outside the validated and FDA-cleared display configuration due to user modification of the manufacturer-installed settings. Modifications included disabling Barco Application Appearance Manager (AAM), altering calibration and compliance parameters, and adjusting additional display-related settings. This field correction is being conducted to restore affected system to the validated configuration and reinforce proper use in accordance with the Operator's Manual.
The potential for repeated frames during HF-OCT pullback when using the Gentuity HF-OCT Console (software version 21.11 to 23.3.13) with the Vis-Rx and Vis-Rx Prime catheters. This correction is intended to ensure that users are fully informed of how to recognize, avoid, and mitigate this condition to maintain accurate longitudinal (length) measurements during OCT imaging.
The non-tamperproof battery door supplied with the sound processor fails to conform to IEC 60601-1-11:2015 by not requiring the use of a tool to replace the button/coin cell battery.
Potential for detachment of a distal tip component of the device during use.
Affected devices exhibited fractures at the distal shaft tip without complete detachment.
Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.
Marketed Without an Approved NDA/ANDA: Product contains undeclared drug ingredients dexamethasone and cyproheptadine.