DrugMar 9, 2022
Preferred Pharmaceuticals Alprazolam Tablets, USP 1mg, Generic for Xanax, Pkg Size: a) 30 recall — FDA D-0642-2022
CGMP deviations
Class IIFDA: TerminatedPreferred Pharmaceuticals, Inc.
March 2022 recalls — page 14
These records include useful source details for the selected month.
VehicleMar 3, 2022
Hyundai Motor front recall — NHTSA campaign 22V123000
Hyundai Motor America (Hyundai) is recalling certain 2022 Elantra and Elantra HEV vehicles. In the event of a crash, the front passenger-side seat belt pretensioner may explode upon…
frontHyundai Motor America
Medical DeviceMar 2, 2022
Biomet Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 14 recall — FDA Z-0672-2022
The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The…
Class IIFDA: TerminatedBiomet, Inc.
Medical DeviceMar 2, 2022
Biomet Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 11 MM, 83 MM Long recall — FDA Z-0674-2022
The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The…
Class IIFDA: TerminatedBiomet, Inc.
Medical DeviceMar 2, 2022
Collagen Matrix RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for recall — FDA Z-0669-2022
Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery
Class IIFDA: TerminatedCollagen Matrix, Inc.
Medical DeviceMar 2, 2022
MEDLINE INDUSTRIES, LP - Northfield meridian bioscience immunocard STAT! Rotavirus test, REF recall — FDA Z-0678-2022
The product was incorrectly shipped at room temperature rather than refrigerated.
Class IIFDA: TerminatedMEDLINE INDUSTRIES, LP - Northfield
Medical DeviceMar 2, 2022
Biomet Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 18 recall — FDA Z-0673-2022
The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The…
Class IIFDA: TerminatedBiomet, Inc.
Medical DeviceMar 2, 2022
Biomet Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 15 MM, 83 MM Long recall — FDA Z-0677-2022
The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The…
Class IIFDA: TerminatedBiomet, Inc.
Medical DeviceMar 2, 2022
Collagen Matrix DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches recall — FDA Z-0668-2022
Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery
Class IIFDA: TerminatedCollagen Matrix, Inc.
Medical DeviceMar 2, 2022
Nobel Biocare Usa NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R recall — FDA Z-0658-2022
Due to 16 complaints related to drivers not engaging in implants. According to the firm's investigations, the incorrect offset gauge was potentially used during production of the implants.…
Class IIFDA: TerminatedNobel Biocare Usa LLC
Medical DeviceMar 2, 2022
Biomet Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 13 MM, 83 MM Long recall — FDA Z-0676-2022
The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The…
Class IIFDA: TerminatedBiomet, Inc.
Medical DeviceMar 2, 2022
Biomet Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 12 MM, 83 MM Long recall — FDA Z-0675-2022
The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The…
Class IIFDA: TerminatedBiomet, Inc.
Medical DeviceMar 2, 2022
Biomet Arcos Modular Revision Hip System, Standard Cone Prox Body, Porous Plasma,Size A, 60 recall — FDA Z-0670-2022
The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The…
Class IIFDA: TerminatedBiomet, Inc.
Medical DeviceMar 2, 2022
Biomet Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 11 recall — FDA Z-0671-2022
The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The…
Class IIFDA: TerminatedBiomet, Inc.
Medical DeviceMar 2, 2022
Medtronic Vascular Endurant, Endurant II and Endurant IIs Stent Graft System: Medtronic recall — FDA Z-0657-2022
Stent Graft Systems built with specific batches of taper tip assemblies have the potential for the taper tip to detach from the delivery system. Detachment of the taper tip during the…
Class IIFDA: OngoingMedtronic Vascular, Inc.
Medical DeviceMar 2, 2022
BALT USA The Optima Coil System consists of an implantable embolization coil comprised of a recall — FDA Z-0660-2022
Due to Label/Pouch mix-up. Pouches incorrectly labeled. Incorrect shelf carton label or pouch label due to inadequate manufacturing line clearance. As a result of this labeling mix-up,…
Class IIFDA: OngoingBALT USA, LLC
Medical DeviceMar 2, 2022
XLTEK IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus recall — FDA Z-0661-2022
Tile kits that allow one to install and situate a video camera within a patient environment are not fitting properly in some domestic institution ceiling tile grids that have a thinner…
Class IIFDA: TerminatedNatus Neurology DBA Excel Tech., Ltd. (XLTEK)
Medical DeviceMar 2, 2022
Becton Dickinson & Company BD Vacutainer Luer Lok Access Device - intended as a sterile recall — FDA Z-0665-2022
May shed contaminant particles into the urine specimen that may be misidentified as Red Blood Cells when used in conjunction with the Sysmex UF-1000i or UX-2000 Analyzers and lead to false…
Class IIIFDA: OngoingBecton Dickinson & Company
Medical DeviceMar 2, 2022
C.R. Bard BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16C recall — FDA Z-0667-2022
There is a potential to leak from the catheter where it connects to the drain bag
Class IIFDA: TerminatedC.R. Bard Inc.
Medical DeviceMar 2, 2022
C.R. Bard BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS14C recall — FDA Z-0666-2022
There is a potential to leak from the catheter where it connects to the drain bag
Class IIFDA: TerminatedC.R. Bard Inc.
FoodMar 2, 2022
Malt Products Diastatic Malt Powder 50lb bag - up to 50 bags per pallet Malt recall — FDA F-0801-2022
Potential Contamination with Salmonella
Class IIFDA: TerminatedMalt Products Corporation
FoodMar 2, 2022
Dole Fresh Vegetables HEB 8oz Shredded Lettuce UPC: 0-41220-35521-1 SKU: 3308 recall — FDA F-0755-2022
Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes.
Class IFDA: TerminatedDole Fresh Vegetables Inc.
FoodMar 2, 2022
Dole 11oz Greener Selection UPC: 0-71430-01008-2 SKU: 34 recall — FDA F-0743-2022
Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes.
Class IFDA: TerminatedDole Fresh Vegetables Inc.
FoodMar 2, 2022
Dole Fresh Vegetables Marketside 12oz Crisp Greens UPC: 6-81131-35503-2 SKU: 3265 recall — FDA F-0758-2022
Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes.
Class IFDA: TerminatedDole Fresh Vegetables 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.