Complete FDA and NHTSA recall records dated in 2019, organized for browsing by month, category and recalling company.
Select a month to review the recall records reported during that period.
Records are ordered by the best available source date.
The firm identified customer sites where modules which the safety pacemaker label is missing. Information regarding the label included in the Operations Manual has been updated to specify:…
It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation.
The recall is being conducted due to a potential defective component on the circuit board causing the charger base to overheat which could result in a charger base malfunction.
Instrument stopped working due to a software lockup, and no patient results are produced.
Atellica IM anti-CCP IgG (aCCP) Test Definition (TDef) Mitigation Failure-reagent carryover mitigation for the Testosterone II (TSTII) assay is unable to be completed as defined in the aCCP…
Customers who utilize PharmGuard Server Software (PGS) with Medfusion 4000 pumps manufactured prior to November 10, 2017, may experience wireless network connectivity issues on certain…
Added an additional SmartWash parameter for the Lithium and Alinity c Lithium Reagent Kit, catalogue number 8L25-30 and 08P5320 to prevent the potential for carryover from the ARCHITECT…
It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation.
Analyte range for Leukocytes for use with the Siemens Multistix method is incorrect. The range was corrected to NEGATIVE to 3+.
Products may contain the incorrect banner card within the kit
Mislabeled outer box of Silk Soymilk Vanilla Bag-In-Box. Outer box incorrectly indicates the product is almond milk instead of soymilk. The internal product in box is labeled correctly as…
Product may contain undeclared allergens, specifically egg and milk
potential presence of foreign material
Product may contain undeclared allergens, specifically egg and milk
Firm was notified on September 11, 2019 that salmon may be contaminated with Listeria monocytogenes
Alfa International Seafood Inc. was notified by Kroger retail stores of complaints from consumers who experienced symptoms of scombroid poisoning after eating yellowfin tuna steaks supplied…
Product was held room temperature and the label stated to keep the product refrigerated.
Temperature Abuse; Product stored and shipped outside of labeled storage requirements.
Label Mix-Up: Product labeled as Quinacrine Dihydrochloride; however, after testing, identified as Artemisinin.
Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020.
cGMP Deviations: firm reported finding metal particulate matter in the filling room near the tube feeder during the filling operation of the product. No particulates were identified in the…
Failed Dissolution Specifications:
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.
