Presence of a Foreign Substance; black particles observed in liquid
All Recalls
95,064 total recalls in our database
Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P
Becton, Dickinson and Company
Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.
Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 M15 (722064), Azurion 7 B12 (722067), Azurion 7 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079, 722224).
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system.
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary bypass vascular catheter
Medtronic Perfusion Systems
Certain lots of product have the potential for a sterile barrier breach.
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardiopulmonary bypass vascular catheter
Medtronic Perfusion Systems
Certain lots of product have the potential for a sterile barrier breach.
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonary bypass vascular catheter
Medtronic Perfusion Systems
Certain lots of product have the potential for a sterile barrier breach.
Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular catheter
Medtronic Perfusion Systems
Certain lots of product have the potential for a sterile barrier breach.
Swan-Ganz Pacing Catheter, Models: D200F7;
Becton, Dickinson and Company
Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; Cardiopulmonary bypass vascular catheter
Medtronic Perfusion Systems
Certain lots of product have the potential for a sterile barrier breach.
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopulmonary bypass vascular catheter
Medtronic Perfusion Systems
Certain lots of product have the potential for a sterile barrier breach.
Potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may be impacted due to mechanical wear of the Float Tabletop control on the control module.
Intervertebral body fusion system straight inserter failed to properly attach to affected cages, which may result in an inability to securely engage the implant with the inserter, which could lead to procedural delay and/or the need to select an alternative implant.
Due to stain present on the surface of affected foley catheters.
Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.
TANGENT ENDOSCOPY
Affected devices exhibited fractures at the distal shaft tip without complete detachment.
Foreign object (stainless steel dust/flakes or shreds of plastic)
Product may contain foreign objects, specifically glass.
Contains undeclared allergens (cashews, milk, and soy).
Foreign object (stainless steel dust/flakes or shreds of plastic)
Foreign object (stainless steel dust/flakes or shreds of plastic)
Swad Mango Flavored Masala Candy
Raja Foods and Vegetables
Contains undeclared Blue 1