95,018 total recalls in our database
Olympia Compounding Pharmacy
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
cGMP Deviations
Intuitive Surgical
As a result of complaint data review, it identified tissue pushout events occurring during firing of the SureForm stapler when tissue is pushed distally within the jaws, rather than being held in place and transected. Overall rate of harm associated with bleeding of critical severity exceeds the predicted likelihood of harm as documented within Intuitives existing risk documentation.
Point of Care (PoC) rapid test products were distributed to customers who did not have a valid CLIA ID.
Freudenberg Medical
Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia
Users need to be aware that embolism is a possible adverse event associated with hydrogel misplacements. Updated IFU provides new procedural instructions, warnings and precautions that describe steps to verify correct placement of the hydrogel following implantation, as well as technique recommendations for the proper placement of SpaceOAR and SpaceOAR Vue.
Siemens Medical Solutions USA
Transducers (component of ultrasound system) may exceed recommended thermal index limits
Users need to be aware that embolism is a possible adverse event associated with hydrogel misplacements. Updated IFU provides new procedural instructions, warnings and precautions that describe steps to verify correct placement of the hydrogel following implantation, as well as technique recommendations for the proper placement of SpaceOAR and SpaceOAR Vue.
Stryker GmbH
The nickel-sensitivity statement on the outer carton may be partially covered by a label resulting in the statement showing "Indicated for patients with Nickel sensitivity" instead of "Not Indicated for patients with Nickel sensitivity".
A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation of test methods used in its manufacture.
Draegar Medical Systems
Software issue resulting in temporary loss of central monitoring functionality.
Siemens Healthcare Diagnostics
Potential for falsely elevated hCG results due to sample carryover in serum and urine patient samples, as well as quality control samples and adjustors.
Siemens Medical Solutions USA
Upgraded software version makes an automatic change in laser configuration settings for "markerless workflow" which may lead to the wrong laser offset coordinates being displayed in the Patient Marking step.
Carl Zeiss Meditec AG
High friction of the slider can cause the device to stick, or not move as intended.
Siemens Medical Solutions USA
Upgraded software version makes an automatic change in laser configuration settings for "markerless workflow" which may lead to the wrong laser offset coordinates being displayed in the Patient Marking step.
A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation of test methods used in its manufacture.
Medtronic formerly Covidien
The audible alarm may not sound and/or the omni-directional LED visual alarm may not display during alarm states. Delayed awareness of alarm states may lead to delayed response or a delay of treatment, potentially resulting in hypoxia, dyspnea, cardiac arrest, or death.
Updated and revised user instructions issued 7/14/22. Potential carryover issue may cause elevated quality control and sample results for heparin, apixaban or rivaroxaban when HemosIL Liquid Anti-Xa reagent is used in the same run with both HemosIL Liquid Antithrombin and HemosIL Q.F.A. Thrombin (Bovine), specific to instrument models that utilize a single reagent probe
Baxter Healthcare
This correction is due to software anomalies occurring during use. If the operator initiates therapy by entering a value other than the default value for the patient Gain/Loss Limit or the Return Pressure Drop Limit (RDL) and uses the Same Patient function, the PrisMax System will return the patient Gain/Loss Limit or the RDL to the default value, rather than the non-default value entered at the initiation of treatment. The PrisMax System interface will display the original values once treatment is restarted but does not have an alert to inform the user of the change. The RDL value will be returned to the original value immediately upon selecting the Same Patient function. The Gain/Loss Limit value will be returned to the original value when the patient weight and/or hematocrit is changed during treatment.
Freudenberg Medical
Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia