💊 Drugs Class I - Dangerous
Failed Dissolution Specifications
All Recalls
95,018 total recalls in our database
💊 Drugs Class I - Dangerous
CGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid instead of foam.
💊 Drugs Class I - Dangerous
Microbial Contamination of Non-Sterile Product
💊 Drugs Class I - Dangerous
Failed Dissolution Specifications
💊 Drugs Class I - Dangerous
Failed Stability Specifications
CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Philips North America
🏥 Medical Devices Class I - Dangerous
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.
Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization.
🏥 Medical Devices Class I - Dangerous
Prior to use on a patient, the device alarm speaker failed to annunciate on power up and the device falsely detected a sensor cable disconnect and reconnect during setup. The monitor detection of a false sensor cable disconnect and reconnect may cause the monitor to discontinue monitoring and transition into the calibration screen without an audible alarm.
greiner bio-one VACUETTE TUBE, 5 ml LH Lithium Heparin Sep, 13x100 green cap-yellow ring, non-ridged, 24 racks of 50 pcs., 1200 pcs. in total, REF 456087P
Greiner Bio-One North America
🏥 Medical Devices Class I - Dangerous
Some of the blood collection tubes show clotting due to variation of Lithium Heparin.
Senior Living Arial Emergency and Nurse Call Systems
Stanley Security Solutions
🏥 Medical Devices Class I - Dangerous
Systems are not alarming due to increased memory consumption.
Medichoice Infant Heel Warmer, Reference # 989805643721 1079906
Philips North America
🏥 Medical Devices Class I - Dangerous
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.
Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300
Draeger Medical
🏥 Medical Devices Class I - Dangerous
26 Fabius MRI Anesthesia machines were distributed with internal hoses routing Oxygen to the Oxygen Flush and Oxygen Flow Control interchanged. If the hospital O2 Central supply pressure is not stable, the O2 fresh gas flow could deviate from the adjusted value. If the deviation is not noticed, insufficient oxygenation of the patient may occur.
VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack
Ortho-Clinical Diagnostics
🏥 Medical Devices Class I - Dangerous
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.
🏥 Medical Devices Class I - Dangerous
Contamination with S. epidermidis
🏥 Medical Devices Class I - Dangerous
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.
Heel Snuggler, Reference # 989805603411 99047
Philips North America
🏥 Medical Devices Class I - Dangerous
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.
🏥 Medical Devices Class I - Dangerous
Medium showed visual turbidity and discoloration, potentially contaminating samples transported for testing.
🏥 Medical Devices Class I - Dangerous
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
🏥 Medical Devices Class I - Dangerous
Impacted lot may leak inside the ARIES instrument.