Lack of sterility assurance for closed suction catheter systems
All Recalls
95,102 total recalls in our database
Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System.
Philips North America
Potential for collimator to fall as a result of incorrect installation.
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Lack of sterility assurance for closed suction catheter systems
Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, Model Number: DYNJ27333F
MEDLINE INDUSTRIES, LP - Northfield
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Lack of sterility assurance for closed suction catheter systems
Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-000 Software Version: N/A Product Description: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets Component: No
Abbott Diagnostics Scarborough
The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
Due to evaporator gasket not sealing which can cause liquid nitrous oxide to drip/leak from the bottom of the device handle during treatment or after treatment during venting of the device
Tandem Mobi Insulin Pump with Interoperable Technology
Tandem Diabetes Care
A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, will cause the pump to incorrectly interpolate glucose trends when the Estimated Glucose Value (EGV) is above 255 mg/dL at the start or end of a gap in data collection due to a lapse in connection from a paired continuous glucose monitor (CGM) sensor, which can lead to under-delivery or over-delivery of insulin based on inaccurate result leading to severe cases of hypoglycemia or hyperglycemia.
The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.
Refer to RES
MEDLINE INDUSTRIES, LP - Northfield
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures which may result in premature battery failure.
Lack of sterility assurance for closed suction catheter systems
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Medline Convenience kits used for various procedures: 1) PAIN PACK, Model Number: DYNJ67577A; 2) PAIN TRIAL PACK, Model Number: DYNJ67576A;
MEDLINE INDUSTRIES, LP - Northfield
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Medline Convenience kits used for various procedures: 1) INTUBATION TRAY, Model Number: MNS10395;
MEDLINE INDUSTRIES, LP - Northfield
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Medline Convenience kits used for various procedures: 1) PRECIP TRAY, Model Number: MNS12590
MEDLINE INDUSTRIES, LP - Northfield
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.