95,025 total recalls in our database
Ortho-Clinical Diagnostics
Lower than expected results for VITROS¿ Immunodiagnostic Products TSH Reagent Pack when diluted with VITROS¿ Immunodiagnostic Products High Sample Diluent A Reagent Pack Lot 2190.
Contamination with S. epidermidis
Software error which affects Sensis Vibe Hemo, Sensis and Sensis Vibe Combo systems with software version VD12A, which could cause possible hazard to patients, operators, or other persons and equipment. Under certain sporadic circumstances, the CO (Cardiac Output) measurement using the Thermodilution method will temporarily no longer be possible.
Philips North America
After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold without new 510(k) clearance.
Medium showed visual turbidity and discoloration, potentially contaminating samples transported for testing.
Mislabeled: Carton box item 138.089- Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 has an implant with measure of 3.5x13mm; and Carton Box (138.107- Easypack Helix GM Acqua has a 3.5x8mm implant instead of a 3.5x 13mm implant
Impacted lot may leak inside the ARIES instrument.
Straumann USA
Mislabeled: Carton box item 138.089- Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 has an implant with measure of 3.5x13mm; and Carton Box (138.107- Easypack Helix GM Acqua has a 3.5x8mm implant instead of a 3.5x 13mm implant
Philips North America
After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold without new 510(k) clearance.
Philips North America
After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold without new 510(k) clearance.
Konica Minolta Healthcare Americas
lmagePilot versions 1.92 and 1.93 paired with an AeroDR or Momentum Panel potential risk of incorrect length measurement/area calculation if incorrect power sequence is followed
Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization.
Compass Health Brands (Corporate Office)
Wheel spoke may crack causing the wheel to separate from the axle may result in patient injuries, including bruising and lacerations requiring stitches.
Unknown Manufacturer
The recalled nightgowns fail to meet flammability standards for children's sleepwear, posing a risk of burn injuries to children.
Unknown Manufacturer
The chain saw can remain running when the switch is on the off position or turn on when plugged in, posing an injury hazard to the user.
Unknown Manufacturer
The lithium-ion battery modules within the Evolve Home Energy Storage Systems can overheat, posing a fire hazard.
Unknown Manufacturer
The recalled loungers can collapse unexpectedly, posing an injury hazard if fingers get caught in the metal folding joints.
Geri-Care Pharmaceuticals, of Brooklyn, New York
The over-the-counter drug products contain regulated substances which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the products is not child resistant, posing a risk of poisoning if the contents are swallowed by young children.
NutraCap Labs
During an FDA investigation the firm was notified that the product contains undeclared milk.
During an FDA investigation the firm was notified that the product contains undeclared milk.