DrugJun 7, 2023
Akorn Tropicamide Ophthalmic Solution, USP 0.1%, 15 mL bottles recall — FDA D-0864-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
Latest records
Latest recalls — page 561
The newest recall records with useful source details are listed here.
DrugJun 7, 2023
Akorn Clobetasol Propionate Cream, USP, 0.05% recall — FDA D-0794-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Levofloxacin Injection 500mg/20 mL (25 mg/mL), For Intravenous Infusion recall — FDA D-0818-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
VehicleJun 7, 2023
Sportage power assist recall — NHTSA campaign 23V410000
Kia America, Inc. (Kia) is recalling certain 2023 Sportage vehicles. The brake booster diaphragm may become misaligned and cause an internal vacuum leak, which can result in a loss of power…
power assistKia America, Inc.
VehicleJun 1, 2023
Ascent lower arm recall — NHTSA campaign 23V392000
Subaru of America, Inc. (Subaru) is recalling certain 2023 Ascent vehicles. The left or right front lower control arm may have an improperly tightened ball joint castle nut which can result…
lower armSubaru of America, Inc.
Medical DeviceMay 31, 2023
binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia recall — FDA Z-1626-2023
May not meet the declared performance characteristics for the detection of Chlamydia trachomatis (CT) within the labeled expiry period, potential to produce either false negative CT or…
Class IIFDA: OngoingBinx Health, Inc.
Medical DeviceMay 31, 2023
Siemens Medical Solutions USA LUMINOS Lotus Max (VF11) recall — FDA Z-1481-2023
Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air kerma/air kerma rate related to the…
Class IIFDA: OngoingSiemens Medical Solutions USA, Inc.
Medical DeviceMay 31, 2023
Windstone Medical Packaging Aligned Medical Solutions Spine Pack, REF: AMS4599 recall — FDA Z-1619-2023
Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an…
Class IIFDA: OngoingWindstone Medical Packaging, Inc.
Medical DeviceMay 31, 2023
Windstone Medical Packaging Aligned Medical Solutions Minor Hand Pack, REF: AMS6539E recall — FDA Z-1620-2023
Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an…
Class IIFDA: OngoingWindstone Medical Packaging, Inc.
Medical DeviceMay 31, 2023
Integra LifeSciences Codman Cranial Hand Drill- Indicated when a craniotomy is required for recall — FDA Z-1614-2023
Released with discoloration (rust) on the Drill Chuck and inner chuck of Codman Cranial Hand Drill may result in inflammation, local toxicity, systemic toxicity, sensitivity, revision…
Class IIFDA: OngoingIntegra LifeSciences Corp.
Medical DeviceMay 31, 2023
Olympus Single Use Distal Cover Model Number MAJ-2315 used with EVIS EXERA III recall — FDA Z-1613-2023
The Single Use Distal Cover MAJ-2315 may cause mucosal injury and/or become detached from the endoscope during use. Consequences of a detached cover could include the risk of aspiration,…
Class IIFDA: OngoingOlympus Corporation of the Americas
Medical DeviceMay 31, 2023
PHILIPS HEADQUARTERS CAMBRIDGE Incisive CT Power- Whole-body computed tomography (CT) X-Ray recall — FDA Z-1624-2023
Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional radiation exposure if a…
Class IIFDA: OngoingPHILIPS HEADQUARTERS CAMBRIDGE
Medical DeviceMay 31, 2023
Siemens Healthcare Diagnostics ADVIA Chemistry ToxAmmonia Calibrator- In vitro diagnostic recall — FDA Z-1631-2023
Reassignment of the Atellica CH Toxicology Calibrators (TOX CAL) and ADVIA Chemistry ToxAmmonia Calibrators for the Atellica CH Salicylate (Sal) Assay due to a positive bias
Class IIFDA: OngoingSiemens Healthcare Diagnostics, Inc.
Medical DeviceMay 31, 2023
Omnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and recall — FDA Z-1617-2023
IVX Station does not account for inherent scale inaccuracy or variability, could result in a preparation being passed that is outside of the dose accuracy stated in the product labeling
Class IIFDA: OngoingOmniCell, Inc.
Medical DeviceMay 31, 2023
PHILIPS HEADQUARTERS CAMBRIDGE Incisive CT Plus -Whole-body computed tomography (CT) X-Ray recall — FDA Z-1625-2023
Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional radiation exposure if a…
Class IIFDA: OngoingPHILIPS HEADQUARTERS CAMBRIDGE
Medical DeviceMay 31, 2023
Siemens Medical Solutions USA Luminos dRF Max (VE10, VF10, VF11) recall — FDA Z-1480-2023
Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air kerma/air kerma rate related to the…
Class IIFDA: OngoingSiemens Medical Solutions USA, Inc.
Medical DeviceMay 31, 2023
PHILIPS HEADQUARTERS CAMBRIDGE Incisive CT- Whole-body computed tomography (CT) X-Ray System recall — FDA Z-1623-2023
Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional radiation exposure if a…
Class IIFDA: OngoingPHILIPS HEADQUARTERS CAMBRIDGE
Medical DeviceMay 31, 2023
Siemens Healthcare Diagnostics Atellica CH Toxicology Calibrator (TOX CAL)-The Atellica CH recall — FDA Z-1632-2023
Reassignment of the Atellica CH Toxicology Calibrators (TOX CAL) and ADVIA Chemistry ToxAmmonia Calibrators for the Atellica CH Salicylate (Sal) Assay due to a positive bias
Class IIFDA: OngoingSiemens Healthcare Diagnostics, Inc.
Medical DeviceMay 31, 2023
Windstone Medical Packaging Aligned Medical Solutions Hand Pack, REF: AmS4601E, containing P recall — FDA Z-1621-2023
Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an…
Class IIFDA: OngoingWindstone Medical Packaging, Inc.
Medical DeviceMay 31, 2023
Olympus Corporation of the Americas To be used with ultrasound endoscopes for ultrasound recall — FDA Z-1616-2023
Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance experienced during needle…
Class IIIFDA: OngoingOlympus Corporation of the Americas
Medical DeviceMay 31, 2023
Ortho-Clinical Diagnostics VITROS Chemistry Products HbA1c Reagent Kit- IVD for the recall — FDA Z-1628-2023
Potential for both unexpected positive and negative HbA1c results, may result in misdiagnosis
Class IIFDA: OngoingOrtho-Clinical Diagnostics, Inc.
Medical DeviceMay 31, 2023
Olympus Corporation of the Americas ViziShot 2 Single Use Aspiration Needle, 21G- To be used recall — FDA Z-1615-2023
Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance experienced during needle…
Class IIIFDA: OngoingOlympus Corporation of the Americas
Medical DeviceMay 31, 2023
PHILIPS HEADQUARTERS CAMBRIDGE Incisive CT- whole-body computed tomography (CT) X-Ray System recall — FDA Z-1622-2023
Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional radiation exposure if a…
Class IIFDA: OngoingPHILIPS HEADQUARTERS CAMBRIDGE
Medical DeviceMay 31, 2023
SD Biosensor Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number recall — FDA Z-1594-2023
The liquid buffer component in the affected test kit lots was determined to have bacterial contamination. User may notice a slight odor when the buffer is brought close to the nose.
Class IFDA: OngoingSD Biosensor, Inc.
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Recent recall archives
Browse recent months with enough recall history for useful comparison.
October 2026110 records · 3 categoriesSeptember 2026364 records · 4 categoriesAugust 2026302 records · 4 categoriesJuly 2026370 records · 4 categoriesJune 2026376 records · 4 categoriesMay 2026340 records · 4 categoriesApril 2026415 records · 4 categoriesMarch 2026190 records · 4 categoriesFebruary 2026331 records · 4 categoriesJanuary 2026212 records · 4 categoriesDecember 2025389 records · 4 categoriesNovember 2025326 records · 4 categories