Myolyn Power electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2 recall — FDA Z-1523-2022
Screws mounting an internal power supply may come loose during shipping resulting in increased risk of high voltage electrical shock.
Complete FDA and NHTSA recall records dated in 2022, 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.
Screws mounting an internal power supply may come loose during shipping resulting in increased risk of high voltage electrical shock.
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
The Sensis Signal Input Box provides hooks as a milled item on the bottom of the box support the possibility of mounting the Signal Input Box on an accessory rail (e.g., at the patient…
Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. Potential risk to to those with latex allergy
Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. Potential risk to to those with latex allergy
Undeclared allergens; wheat and soy.
Detectable levels of Per- and polyfluoroalkyl substances (PFAS).
The firm was notified by their rice supplier that the product may contain small pieces of glass.
Undeclared allergens; fish and shellfish
The firm was notified by their rice supplier that the product may contain small pieces of glass.
Undeclared wheat
Firm's internal sampling identified a positive Salmonella result on Item 00113 that was on hand at the firm on 7/15/2022. Firm elected to hold all inventory between the sanitation break…
Undeclared allergens; fish, shellfish, egg, and wheat
Undeclared allergens; fish, shellfish, egg, wheat, and soy
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Chemical Contamination and Subpotent Drug: FDA analysis found product to contain methanol and below label claim for ethanol.
Temperature Abuse: Product distributed in refrigerated trucks with labels attached to pallets indicating "Refrigerate Upon Arrival", however product is labeled to be stored in a controlled…
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.
Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of Zynrelef 400 mg/12 mg kit
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.
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.