Complete FDA and NHTSA recall records dated in 2021, 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.
A deformity affecting a specific lot of VITROS Chemistry Products VersaTips. Deformed VersaTips results may be biased by up to +/-16% for both immunometric and competitive assays.
incorrect device is contained in the package. The packaging label indicates that the device is for left side use, the product inside the package is for right side use. Use of an opposite…
Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non-sterile sticker.
Misleading error messages and a gap in the Operator Manual which affects ARTIS Icono biplane or ARTIS Icono floor systems with software version VE20B. Potential issues include System error…
Slits were identified in a low quantity of ORS-320 Slush + Warmer Disc Drapes from a single lot. A source for potential manufacturing error was identified and investigation is underway to…
An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device.
Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non-sterile sticker.
On January 7, 2021, STERIS identified that the glued bond between the beam and the leg spar assembly may begin to separate over time. This could result in unexpected movement of the…
Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non-sterile sticker.
An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device.
The external drainage system failed to meet Pyrogen test requirements for devices contacting cerebrospinal fluid of 2.15 endotoxins.
Due to unqualified "design verification" batteries being shipped to customers.
Potential for Clostridium botulinum. Products were produced and sold without licensure and regulatory oversight.
Small round fragments of plastic, the size of a dime, were found in the plastic bag during packaging. They had been left in the bag by the package manufacturer.
Undeclared anchovies
The firm received a consumer complaints that the product was spoiled.
undeclared cashews and almonds.
QA Allergen check by manufacturer noticed that Soy lecithin was not declared on the label.
Potential undeclared allergens (wheat and tree nuts)
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile…
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile…
Microbial Contamination of Non-Sterile Product: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for…
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile…
Labeling: Label mix-up: Carton of Cisatracurium Besylate Injection, USP was observed to contain ten vials mislabeled as Phenylephrine Hydrochloride Injection, USP, but confirmed to contain…
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.
