All Recalls

The ingredient Triticale is not identified as wheat.

Label declares Cream & Yogurt but does not declare milk.

Presence of foreign material in food (plastic)

contains undeclared peanuts

Product has the potential to be contaminated with Listeria monocytogenes. The condiment pack in the salad kit contains cheese recalled by the cheese supplier.

Hummus product label declares Tahini but does not declare sesame.

contains undeclared soy and egg

Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.

Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyond-use date.

an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could cause a medically reversible or transient adverse health consequences.

Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.

GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, 3000 and 4000 Incubator, Lullaby Incubator, Lullaby TR Incubator, and Lullaby XP Incubator can be upright and look closed but not be latched if the red indicator is visible. The portholes also can look closed when not latched when the portholes are obstructed e.g., hood covers. If a patient impacts the bedside panel or porthole that is not latched, the panel can disengage and fall open, no longer protecting the patient from falling.

The microcatheter IFU contains an intended use that has not been evaluated by the FDA.

Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) panel.

The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may result in inflammation, sepsis, or infection.

New warnings are being added to the Instructions for Use for all affected products to reduce the possibility of fibers being drawn into the Impella, which may result in low flow of the device.

While cleaning or disinfecting the system, if the process is not followed as described in the manual and excessive liquid is used or sprayed directly on the system, it could cause a short circuit of the fine positioning control button. This would result in the system moving on its own in a very slow speed forward circular motion.

The microcatheter IFU contains an intended use that has not been evaluated by the FDA.

Issue 1: Mixed Images: The Radio Fluoroscopy (RF) viewer may also display a previous patients radiography (RAD) images when starting the next patient scan while the previous patient image export is still processing. If the issue occurs, there is a potential for incorrect patient data to be displayed in the image. Issue 2: Detector Access point: Security vulnerability specific to the Wireless Portable Detector configuration items in Philips Support Connect (PSC). Due to this vulnerability it is possible, with physical access to the system and knowledge of specific settings, to modify and export data to removable media (example: USB)

Spring arm failure with Captus 4000e Thyroid Uptake Systems, can cause the collimator to fall downward to its lowest point of travel, causing potential injury with a patient or operator