Complete FDA and NHTSA recall records dated in March 2022.
These records include useful source details for the selected month.
Due to the inadequate adjusting criteria in installation, the system generator on two Digital Angiography Systems, the irradiated x-ray may exceed the x-ray radiation dose rate in…
There is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by the pipettor robot.
A limited number of ventilators were assembled with expired adhesive. If the adhesive fails, a bracket may become loose and potentially damage the capacitors, which could cause the…
Conductive Cannula Reducer metal tip may get dislodged from the plastic shaft. If unnoticed, additional surgery may be required to remove the metal tip. If the procedure proceeds without…
There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the…
Product was labelled with the incorrect manufacturing and distribution dates.
There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the…
The Lactobacillus acidophilus negative control (item 0243 single KWIK-STIK) contained in the 8164 Cepheid Xpert GBS QC Set and 8165 Cepheid Smart GBS QC Set was found to test positive for…
The design of the seats did not consistently have the adequate strength required to support the customers weight with continued use.
A limited number of ventilators were assembled with expired adhesive. If the adhesive fails, a bracket may become loose and potentially damage the capacitors, which could cause the…
Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dilators from these lots and…
Real-time shelf life testing failed at 24 months
There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the…
This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. A specific lot was found susceptible to Gentamicin Synergy during in-house testing.
There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the…
Potential exposure to rodents and rodent activity in the distribution center.
Pecans although listed in the Ingredient Statement, was omitted from the CONTAINS statement.
Chips may contain a foreign material (metal).
Signature Select Black Walnut Ice Cream was inadvertently packed in Cookie Dough container that does not declare nuts as allergen. Top lid correctly identified Black Walnut flavor.
Product may potentially contain blue plastic pieces.
Potential exposure to rodents and rodent activity in the distribution center.
Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product.
CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center.
Labeling: Label Mix-Up-The primary label on the front of the bottles have 50% Isopropyl Alcohol affixed to the containers. However, the product inside the bottle is Hydrogen Peroxide,…
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.
