Complete FDA and NHTSA recall records dated in August 2019.
These records include useful source details for the selected month.
In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance…
The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully comply with the FDA's Manual Reset Mechanism requirement for laser projectors and could…
Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.
Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability
Additional Instructions: step-by step handling and inserting the cassette into the Liberty Cycler set. A damaged cassette can cause peritoneal dialysis (PD) solution to leak into the cycler…
The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully comply with the FDA's Manual Reset Mechanism requirement for laser projectors and could…
There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.
There is a potential for the single use suction valve to come apart and/or remain stuck inside the endoscope.
Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.
In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance…
Salivary assay may observe a higher percentage of samples with 0 pg/ml testosterone or results which are too low. Saliva samples in the low measuring range of the kit(< 50 pg/ml) were…
Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated.…
There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.
When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen.
Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.
Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated.…
There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.
The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully comply with the FDA's Manual Reset Mechanism requirement for laser projectors and could…
Apple has determined that, in a limited number of older generation 15-inch MacBook Pro Units, the battery may overheat and pose a fire safety risk. To date, Intellijoint has distributed,…
Potential for sterile packaging to be compromised
Lasers/Catheters did not calibrate during set-up prior to use.
Negative Bias with Lot EA9227.
There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure.
Potential for sterile packaging to be compromised
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.
