Complete FDA and NHTSA recall records dated in June 2020.
These records include useful source details for the selected month.
HeartStart XL MonitorlDefibrillators may not have been included in prior field actions and received required corrections
The analyzers fail on S7950 (Range +) QC measurements due to the hemolyzer cuvettes, a subcomponent of the optical system which measures ctHb and derivates. In a cuvette with light shunt,…
The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to "use by date" displayed on…
Tungsten coils of the guidewire included in the introducer kit were detaching.
The spike rail was manufactured with an oversized thru-hole which could potentially cause the dowel pin to fall out and the device to disassemble.
Potential presence of elevated endotoxin levels that exceed the specification limit
Potential presence of elevated endotoxin levels that exceed the specification limit
The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to the "use by date" displayed…
Potential presence of elevated endotoxin levels that exceed the specification limit
The identified problem is an erroneous association between the carrier and the sample tube caused by a communication error between the firmware of the Interface Modules and the Automation…
During Giraffe Shuttle charging, the batteries emit low concentrations of gases (outgassing) producing a strong sulfur odor.
Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection)
Internal Paddles may wear over time and may not be safe or ready for use, unless the directions in the Instructions for Use (IFU) to perform routine operational checks are followed. The…
Reagent component included in flu test kit may cause both high background signal in a true negative sample leading to false positive and/or false negative results. This could result in…
The seal of the sterile pouch may be compromised on one lot of the Milex Cervical Dilators.
An incorrect component used during manufacturing. The uterine manipulator tip support does not have the "notch" required to attach the spacer and or colpotomy cup. This may result in a…
There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to tissue damage.
HeartStart XL MonitorlDefibrillators may not have been included in prior field actions and received required corrections
Potential presence of elevated endotoxin levels that exceed the specification limit
Potential presence of elevated endotoxin levels that exceed the specification limit
Some cameras were found to have residual soil adhered to the tip of the camera after reprocessing which may affect image quality resulting in needing to switch to a second camera or…
The spike rail was manufactured with an oversized thru-hole which could potentially cause the dowel pin to fall out and the device to disassemble.
The unplugging of the main cable on the monitor trolley from the X10 connector can cause an unsafe electrical voltage (up to 67,6 V DC) at the X10 connector. This can result in an…
Potential presence of elevated endotoxin levels that exceed the specification limit
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.
