Complete FDA and NHTSA recall records dated in August 2018.
These records include useful source details for the selected month.
Two lots of femoral stems were labeled as Size 11. However, they are actually Size 12. Potential adverse effects include poor joint mechanics, improper fit, loosening, and additional…
It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. This may cause media to leak out of the primary sterile packaging…
It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. This may cause media to leak out of the primary sterile packaging…
Possibility that the retaining ring in the 2M inlay 15degree for MUTARS RS Cup and LUMiC TiN is incorrectly mounted.
During manual LAO/RAO rotation at maximum speed or a combination of LAO/RAO and Cran/Caud rotation at maximum speed, the possibility exists for the safety monitoring within the system…
Abbott is advising customers that a small number of CardioMEMS(R) Hospital Electronics Systems (Model CM3000) and Patient Electronics Systems (Model CM1100) may deliver a system error,…
An improper wiring connection on the chiller assembly may result in overheating of the connection and potential failure of certain components in the system.
The product label has missing information, such as the lot number and expiration date, as well as other information.
The main vial label lists the incorrect part number, but the cap label is correct.
Potential to contain metal fragments
Whey powder may have the potential to be contaminated with Salmonella.
This recall has been identified due to the detection of cyclamates (artificial sweetener). Use of or consumption of cyclamates may include potential health hazard. Cyclamates and its salts…
This recall has been identified due to the detection of cyclamates (artificial sweetener). Use of or consumption of cyclamates may include potential health hazard. Cyclamates and its salts…
an ingredient in this product was manufactured during the time-frame and on the same piece of equipment that was associated with a salmonella outbreak.
It was discovered that a bulk salad kit was produced using the wrong components. Instead of cashews, peanuts were packed for the kit
Product labeling does not list milk in the contains statement; however milk is listed as in ingredient.
This recall has been identified due to the detection of cyclamates (artificial sweetener). Use of or consumption of cyclamates may include potential health hazard. Cyclamates and its salts…
Potential to contain metal fragments
Product is decomposed.
This recall has been identified due to the detection of cyclamates (artificial sweetener). Use of or consumption of cyclamates may include potential health hazard. Cyclamates and its salts…
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Presence of Particulate Matter: organic and inorganic compounds detected in vials of product.
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.
