Complete FDA and NHTSA recall records dated in January 2019.
These records include useful source details for the selected month.
Labeling; Label Error on Declared Strength; label incorrectly states the concentration as 50 mg/50 mL (1 mg/mL) rather than the fully accurate concentration as 50 Units/50 mL (1 Unit/mL)
Failed Impurities/Degradation Specifications: Expansion of October 2018 recall due to elevated out of specification results for total impurities that have been chemically identified as…
Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil
Labeling Not Elsewhere Classified: The front panel indicates 24 caplets whereas the side panel indicates 12 caplets. The drug product carton contains 24 caplets.
Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the Epi-Safe Kits for the Epi-Safe Syringe (and/or the Safety Lok Syringe in…
Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the Epi-Safe Kits for the Epi-Safe Syringe (and/or the Safety Lok Syringe in…
Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the Epi-Safe Kits for the Epi-Safe Syringe (and/or the Safety Lok Syringe in…
Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the Epi-Safe Kits for the Epi-Safe Syringe (and/or the Safety Lok Syringe in…
BMW of North America, LLC (BMW) is recalling certain 2018-2019 BMW X1 sDrive28i and X1 xDrive28i vehicles. Contaminated hardware may cause the attachment brackets of the taillight housings…
Honda (American Honda Motor Co.) is recalling certain 2016-2018 Acura MDX, 2015-2019 Acura TLX and 2015-2017 Honda Accord vehicles, equipped with a 3.5L V6 engine. Particulates in fuel may…
Chrysler (FCA US LLC) is recalling certain 2019 Ram 1500 vehicles. The battery ground fastener on the driver-side front fender may have been improperly secured, possibly resulting in a loss…
Chrysler (FCA US LLC) is recalling certain 2019 RAM 1500 vehicles equipped with a 12" touchscreen display and a base-level heating, ventilation and air conditioning ("HVAC") system.…
The product may be packaged with a 5FR X 24 length Feeding tube instead of a 6.5 FR X 24 Feeding tube as labeled.
Enteral Safe Feeding Tubes labeled as 6.5 FR X 24" contained 5 FR X 24" Enteral Safe Feeding Tubes.
The internal labeling included with these implants may include incorrect part numbers and could result in these incorrect labels being added to patient records.
If the head mount knob is not properly tightened and the operator directly uses the injector head to move the unit, it may become disengaged, causing the injector head to become loose or…
The lidstock states the incorrect priming volume and flow rates.
Visions PV .035 Intravascular Ultrasound (IVUS) Catheters (catalog number 88901 adnd81234) due to the potential inability to pass the guidewire through the y-port of the catheter.
Visions PV .035 Intravascular Ultrasound (IVUS) Catheters (catalog number 88901 adnd81234) due to the potential inability to pass the guidewire through the y-port of the catheter.
There is a potential for silicone shedding during cleaning and sterilization.
The internal labeling included with these implants may include incorrect part numbers and could result in these incorrect labels being added to patient records.
Potentially lead to anchor breakage during insertion,
The stage 1 and 2 reamer instruments used to prepare fixation for the cup in the acetabulum had a -1mm interference fit with acetabulum bone. The expected interference fit is -2mm.
The pin that holds the spring mechanism is not properly mounted. The pin could potentially disassemble.
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.
