FoodJun 30, 2021
Banner Smoked Fish Inc recall — FDA F-0714-2021
Product may be contaminated with Listeria monocytogenes.
Class IFDA: TerminatedBanner Smoked Fish Inc.
June 2021 recalls — page 5
These records include useful source details for the selected month.
DrugJun 30, 2021
Miracle 8989 PremierZEN Gold 7000 capsule, 1-count blister card recall — FDA D-0633-2021
Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
Class IFDA: TerminatedMiracle 8989
DrugJun 30, 2021
Miracle 8989 PremierZEN Platinum 8000 capsule, 1-count blister card (UPC 7 28175 42185 6) recall — FDA D-0634-2021
Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
Class IFDA: TerminatedMiracle 8989
DrugJun 30, 2021
Teligent Pharma Diflorasone Diacetate Ointment USP, 0.05% recall — FDA D-0636-2021
Presence of Foreign Substance: Foreign particles observed during routine stability testing.
Class IIFDA: TerminatedTeligent Pharma, Inc.
DrugJun 30, 2021
DermOtic Oil recall — FDA D-0637-2021
Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.
Class IIFDA: TerminatedHill Dermaceuticals, Inc.
DrugJun 30, 2021
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 Tablets recall — FDA D-0640-2021
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Class IIFDA: TerminatedVIONA PHARMACEUTICALS Inc.
VehicleJun 30, 2021
Volkswagen Group of air bag control module recall — NHTSA campaign 21V492000
Volkswagen Group of America, Inc. (Volkswagen) is recalling certain 2020-2021 Jetta and Jetta GLI vehicles. The air bag control module was welded in the incorrect position.
air bag control moduleVolkswagen Group of America, Inc.
VehicleJun 24, 2021
General Motors frontal impact recall — NHTSA campaign 21V472000
General Motors, LLC (GM) is recalling certain 2021 Chevrolet Traverse and Buick Enclave vehicles. During service by dealers, certain vehicles may have received incorrect air bag calibration…
frontal impactGeneral Motors, LLC
VehicleJun 24, 2021
Rogue mid/rear recall — NHTSA campaign 21V474000
Nissan North America, Inc. (Nissan) is recalling certain 2021 Rogue vehicles. The second-row upper tether wires may have been improperly welded to the seatback frame, preventing a child…
mid/rearNissan North America, Inc.
Medical DeviceJun 23, 2021
Medtronic HY8R62R13,Custom Pack HY8R62R13 E Pack, Custom Perfusion System, Sterile, Rx recall — FDA Z-1880-2021
Specific lots may have been manufactured with insufficient or incomplete welds.
Class IIFDA: TerminatedMedtronic Perfusion Systems
Medical DeviceJun 23, 2021
Medtronic HY8M63R4, Custom Pack HY8M63R4 Adult ECC, Custom Perfusion System, Sterile, Rx recall — FDA Z-1872-2021
Specific lots may have been manufactured with insufficient or incomplete welds.
Class IIFDA: TerminatedMedtronic Perfusion Systems
Medical DeviceJun 23, 2021
Medtronic Vascular Angiographic Guidewire Component recall — FDA Z-1860-2021
The component part numbers intended for shipment to a third-party, where they are further processed into kits and sterilized were instead shipped directly to customers.
Class IFDA: TerminatedMedtronic Vascular
Medical DeviceJun 23, 2021
Medtronic CB1H18R20, Custom Pack CB1H18R20 Accesory, Custom Perfusion System, Sterile, Rx recall — FDA Z-1878-2021
Specific lots may have been manufactured with insufficient or incomplete welds.
Class IIFDA: TerminatedMedtronic Perfusion Systems
Medical DeviceJun 23, 2021
Johnson & Johnson Vision Care ACUVUE VITA soft (hydrophilic) contact lens (spherical) for recall — FDA Z-1865-2021
Potential that a limited number of individual contact lens packages have an incomplete packaging seal.
Class IIFDA: TerminatedJohnson & Johnson Vision Care, Inc.
Medical DeviceJun 23, 2021
Windstone Medical Packaging Angio Pack REF: AMS8050A, Sterile EO, Contents:2 Glove recall — FDA Z-1849-2021
Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld
Class IIFDA: TerminatedWindstone Medical Packaging, Inc.
Medical DeviceJun 23, 2021
Medtronic HY7M07R6, Custom Pack HY7M07R6 E 1/4, Custom Perfusion System, Sterile, Rx recall — FDA Z-1875-2021
Specific lots may have been manufactured with insufficient or incomplete welds.
Class IIFDA: TerminatedMedtronic Perfusion Systems
Medical DeviceJun 23, 2021
Corin TriFit CF SIZE 7, LATERALISED 127o, COMBINED FIXATION STEM, CEMENTLESS, REF 6961007 recall — FDA Z-1851-2021
Units from one batch of TriFit TS size 2 stem were found to be labeled as a TriFit CF size 7 stem. And vice versa.
Class IIFDA: TerminatedCorin Ltd
Medical DeviceJun 23, 2021
Medtronic 1A46R11, Custom Pack 1A46R11 Neonatal, Custom Perfusion System, Sterile, Rx recall — FDA Z-1895-2021
Specific lots may have been manufactured with insufficient or incomplete welds.
Class IIFDA: TerminatedMedtronic Perfusion Systems
Medical DeviceJun 23, 2021
Bard Peripheral Vascular VENOVO Venous Stent System 10F Product Description(REF)/dimension recall — FDA Z-1897-2021
Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.
Class IIFDA: OngoingBard Peripheral Vascular Inc.
Medical DeviceJun 23, 2021
Abbott Laboratories v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System recall — FDA Z-1853-2021
Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.
Class IIFDA: TerminatedAbbott Laboratories Inc. (St Jude Medical)
Medical DeviceJun 23, 2021
Medtronic CB10R55R5, Custom Pack CB10R55R5 3/8X3/8 Loop, Custom Perfusion System, Sterile recall — FDA Z-1888-2021
Specific lots may have been manufactured with insufficient or incomplete welds.
Class IIFDA: TerminatedMedtronic Perfusion Systems
Medical DeviceJun 23, 2021
Covidien HME for Tracheostomized Patients, Item Code 353S13046 - Product Usage: indicated recall — FDA Z-1869-2021
The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization.
Class IIFDA: OngoingCovidien, LP
Medical DeviceJun 23, 2021
Radiometer ABL90 FLEX PLUS Analyzer with E3800 PC units recall — FDA Z-1857-2021
Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.
Class IIFDA: OngoingRadiometer Medical ApS
Medical DeviceJun 23, 2021
Windstone Medical Packaging Angio Pack REF: AMS6908C, Sterile EO, Contents:1 Blade Scalpel # recall — FDA Z-1848-2021
Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld
Class IIFDA: TerminatedWindstone Medical Packaging, Inc.
How to use this monthly recall archive
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.