All recalls8,501 total
Potentially under pasteurized. The firm was notified by the California Department of Agriculture that due to the broken seal on the pasteurizer, the products may be under pasteurized, and they should recall the products.
Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate patients, which may distract clinicians away from management of true positive alarms, which could delay treatment; 2) Small and medium size blood pressure cuffs may contain rough edges, may result in skin irritation/redness.
Due to a quality issue regarding the presence of burr on the finished cervical plate product.
Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate patients, which may distract clinicians away from management of true positive alarms, which could delay treatment; 2) Small and medium size blood pressure cuffs may contain rough edges, may result in skin irritation/redness.
Products may be contaminated with Listeria monocytogenes.
Potential contamination with listeria monocytogenes.
Products may be contaminated with Listeria monocytogenes.
Products may be contaminated with Listeria monocytogenes.
Products may be contaminated with Listeria monocytogenes.
Potential contamination with listeria monocytogenes.
Products may be contaminated with Listeria monocytogenes.
Products may be contaminated with Listeria monocytogenes.
Products may be contaminated with Listeria monocytogenes.
Products may be contaminated with Listeria monocytogenes.
Products may be contaminated with Listeria monocytogenes.
Products may be contaminated with Listeria monocytogenes.
Products may be contaminated with Listeria monocytogenes.
Products contain cyclamates (banned sweetener)
Products contain cyclamates (banned sweetener)
Products may be contaminated with Listeria monocytogenes.
Products may be contaminated with Listeria monocytogenes.
Products may be contaminated with Listeria monocytogenes.
Products contain cyclamates (banned sweetener)
Failed Tablet/Capsule Specifications
Due to identifying a limited quantity of intraocular lenses that may have a haptic that sticks to the optic which prevents the lens from unfolding as consistently as expected.
Undeclared sesame seed ingredient in hamburger buns.
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Stability Data Does Not Support Expiry Date.
Stability Data Does Not Support Expiry Date.
Stability Data Does Not Support Expiry Date.
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Urgent Medical Device Correction for the Volara system single-patient use circuit due to the potential that patients or caregivers may be unaware of a possible decrease in oxygen levels (oxygen desaturation), or potential lung tissue injury from overexpansion (barotrauma) when the Volara device is used in the home care environment. This correction is providing the home caregiver specific instructions for use.
Display screen may unintentionally flicker due to a software issue. Exposure to flickering lights may induce photosensitive seizure activity in susceptible individuals.
There is a potential breach in the sterile pouch packaging for one lot of radiology kits, which may compromise product sterility.
Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Due to adapter not being properly aligned or locked in place.
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Increased risk of purge leaks with Generation 1 purge cassettes.
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Cribs sold in the USA are missing two access door warning labels.
Due to product exhibiting potential to generate either invalid or false negative results.
If heating pad is folded while in use, the power density increases in the folded area causing excessive temperatures, which can also be caused by placing pad under the body, then the high limit device is unable to sense the higher temperature so power is not terminated. May cause a burning smell prior to melting/burning potentially causing burns to persons and property.
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Foreign plastic material discovered on fill line.
Foreign plastic material discovered on fill line.
Foreign plastic material discovered on fill line.