Complete FDA and NHTSA recall records dated in January 2020.
These records include useful source details for the selected month.
An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. After testing, it was found that…
Potential power issues with the Accu-Chek Guide Blood Glucose Monitoring System.
The products are labeled as Class II lasers. However, the level of laser radiation emitted by the distributed products may exceed the limit (1 mW) established for Class II lasers. These…
Invia Foam Dressing Kit with FitPad could have holes in the sterile packaging.
The electromagnetic noise exceeded the upper limit of the Electromagnetic Compatibility Standard (EMC: IEC 60601-1-2)
Potential power issues with the Accu-Chek Guide Blood Glucose Monitoring System.
Potential power issues with the Accu-Chek Guide Blood Glucose Monitoring System.
An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. After testing, it was found that…
An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. After testing, it was found that…
Under certain fault conditions, the existing design may expose the operator to a hazardous voltage when contacting the metal enclosure (including mounting screws) around the up/down switch.
An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. After testing, it was found that…
i-STAT cTnI blue cartridges may generate a higher than expected number of quality check codes. The observed rate of quality check codes could be in the 3 to 5% range.
Excessive static electricity can potentially cause unrecoverable power loss and damage to the mobile power unit that can be used to power the left ventricular assist system, which could…
It has been determined that some Pedicle system screw identified as 45mm long have an actual length of 50mm. Pedicle screws with a diameter of 7.5 mm or more are reserved for the sacrum…
Water from a roof leak may have dripped on chips prior to packaging
One case (out of 4332 cases) of pine nuts was found to have been packed into macadamia nut pouches instead of pine nut pouches.
It was discovered that one batch of sardines were incorrectly labeled - Sardines in Water instead of Sardines in Tomato sauce.
undeclared FD & C Red 40
Superpotent Drug: Salicylic acid content is above the firm's specification.
CGMP Deviations: Presence of NDMA impurity detected in product.
Marketed Without an Approved NDA/ANDA; Product contains undeclared active ingredient - Sildenafil.
Unit Dose Mispackaging: Customer complaint that a carton labeled as Myorisan 20 mg Capsules, USP erroneously contained one 10-count blister card of the 40 mg product in addition to two…
Potential for the instability of the diluents VITROS 7% BSA (Product Code 8262487) and VITROS Urine Electrolyte Diluent (UED) (Product Code 1110352) when stored in a 2mL cup for 7 days
Potential for the instability of the diluents VITROS 7% BSA (Product Code 8262487) and VITROS Urine Electrolyte Diluent (UED) (Product Code 1110352) when stored in a 2mL cup for 7 days.
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.
