DrugSep 27, 2023
Humanrace Suncare, Ozone Body Protection Cream, Broad Spectrum Sunscreen SPF 30, packaged as recall — FDA D-1176-2023
Subpotent Drug: Product does not contain SPF that is declared on the label.
Class IIFDA: OngoingHUMANRACE
September 2023 recalls — page 4
These records include useful source details for the selected month.
DrugSep 27, 2023
Humanrace Suncare, Ozone Face Protection Daily Moisturizer, Broad Spectrum Sunscreen SPF 30 recall — FDA D-1175-2023
Subpotent Drug: Product does not contain SPF that is declared on the label.
Class IIFDA: OngoingHUMANRACE
DrugSep 27, 2023
CHLORAPREP ONE-STEP BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v recall — FDA D-1168-2023
Stability data does not support expiry: Shelf-life of the impacted lots of BD ChloraPrep" Clear 1 mL Applicator cannot be substantiated beyond 12-months although labeled with 36-month…
Class IIFDA: CompletedCareFusion 213, LLC
VehicleSep 22, 2023
Forte lower arm recall — NHTSA campaign 23V649000
Kia America, Inc. (Kia) is recalling certain 2023 Forte vehicles. The right front lower control arm may have been improperly welded, which can cause it to fail.
lower armKia America, Inc.
VehicleSep 21, 2023
Subaru of driveshaft recall — NHTSA campaign 23V647000
Subaru of America, Inc. (Subaru) is recalling certain 2023 Outback, Legacy, Ascent, and Impreza vehicles. The center support bolts for the driveshaft may loosen, resulting in the…
driveshaftSubaru of America, Inc.
Medical DeviceSep 20, 2023
Landauer NanoDots, Model Numbers: a) BC30023, description: QC Set For Microstar Dots recall — FDA Z-2573-2023
LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a…
Class IIFDA: CompletedLandauer
Medical DeviceSep 20, 2023
Landauer nanoDot D2DNN, Model Numbers: a) 03051-1MO recall — FDA Z-2540-2023
LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a…
Class IIFDA: CompletedLandauer
Medical DeviceSep 20, 2023
Abbott Medical Proclaim Plus 7 Implantable Pulse Generator REF 3672 Product Description: The recall — FDA Z-2508-2023
Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).
Class IFDA: OngoingAbbott Medical
Medical DeviceSep 20, 2023
Landauer Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 04217-000 recall — FDA Z-2557-2023
LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a…
Class IIFDA: CompletedLandauer
Medical DeviceSep 20, 2023
Landauer Calibrate (unexposed) nanoDot D2DNS, Model Numbers: a) 18140-000 recall — FDA Z-2570-2023
LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a…
Class IIFDA: CompletedLandauer
Medical DeviceSep 20, 2023
Advance Medical Designs procedural kits containing ultrasonic transmission gel, Item recall — FDA Z-2537-2023
Ultrasound gel mislabeled with inappropriate use.
Class IIFDA: OngoingAdvance Medical Designs, Inc.
Medical DeviceSep 20, 2023
Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 recall — FDA Z-2450-2023
The One-Way Valve, 22F x 22M may stick and prevent or reduce the flow of ventilated air or oxygen.
Class IFDA: OngoingMallinckrodt Manufacturing LLC
Medical DeviceSep 20, 2023
Landauer nanoDot D2DNN , Model Numbers: a) 04293-000 recall — FDA Z-2561-2023
LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a…
Class IIFDA: CompletedLandauer
Medical DeviceSep 20, 2023
remel TODD HEWITT W recall — FDA Z-2531-2023
On lot of Todd Hewitt Broth w/CNA (LIM) may exhibit no recovery of target organism during customer QC testing or use with patient samples
Class IIFDA: OngoingRemel, Inc.
Medical DeviceSep 20, 2023
Abbott Medical Proclaim DRG Implantable Pulse Generator REF 3664 Product Description: The recall — FDA Z-2509-2023
Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).
Class IFDA: OngoingAbbott Medical
Medical DeviceSep 20, 2023
Abbott Medical Proclaim" XR 7 Implantable Pulse Generator REF 3662 recall — FDA Z-2506-2023
Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).
Class IFDA: OngoingAbbott Medical
Medical DeviceSep 20, 2023
Landauer nanoDot D2DXN, Model Numbers: a) 03060-1MO recall — FDA Z-2545-2023
LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a…
Class IIFDA: CompletedLandauer
Medical DeviceSep 20, 2023
Landauer Calibrate (Cs-137) nanoDot D2DNS, Model Numbers: a) 18125-000 recall — FDA Z-2566-2023
LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a…
Class IIFDA: CompletedLandauer
Medical DeviceSep 20, 2023
Landauer nanoDot D2DNS, Model Numbers: a) 03055-1MO recall — FDA Z-2542-2023
LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a…
Class IIFDA: CompletedLandauer
Medical DeviceSep 20, 2023
Landauer QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 04218-000 (EMEA number VINLNAN004) recall — FDA Z-2558-2023
LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a…
Class IIFDA: CompletedLandauer
Medical DeviceSep 20, 2023
Landauer Calibrate (Cs-137) nanoDot D2DNS, Model Numbers: a) 04224-000 recall — FDA Z-2559-2023
LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a…
Class IIFDA: CompletedLandauer
Medical DeviceSep 20, 2023
Landauer nanoDot C - item 3 of 3 for 03500-000, Model Number 03503-000 recall — FDA Z-2556-2023
LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a…
Class IIFDA: CompletedLandauer
Medical DeviceSep 20, 2023
Landauer QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 18131-000 recall — FDA Z-2568-2023
LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a…
Class IIFDA: CompletedLandauer
Medical DeviceSep 20, 2023
Keystone Industries Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture recall — FDA Z-2580-2023
The Hard Line Chairside Reline Kit (570-0718) (0921940HS) was labeled as Soft Line Chairside Reline Kit (570-0717) (0921250HS) on the outer box. The contents of the Kit and the IFU enclosed…
Class IIFDA: OngoingKeystone Industries
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.