DrugOct 23, 2024
Cisplatin Injection, 100mg/100mL (1mg/mL), For Intravenous Use, 100 mL Multiple Dose Vial recall — FDA D-0010-2025
Failed Impurities/Degradation Specifications.
Class IIFDA: TerminatedACCORD HEALTHCARE, INC.
October 2024 recalls — page 9
These records include useful source details for the selected month.
DrugOct 23, 2024
Atovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle recall — FDA D-0012-2025
Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.
Class IFDA: TerminatedBionpharma Inc.
DrugOct 23, 2024
First Aid Antiseptic Ointment, Povidone Iodine USP 10%, Inactive Ingredients: mineral oil recall — FDA D-0013-2025
Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as "mineral oil , petrolatum ". The inactive ingredients in the actual product…
Class IIFDA: OngoingZhejiang Jingwei Pharmaceutical Co., Ltd.
VehicleOct 18, 2024
Maverick vehicle tether anchor recall — NHTSA campaign 24V778000
Ford Motor Company (Ford) is recalling certain 2024 Maverick vehicles. The second-row child seat tether anchors may not properly secure a child seat, due to incomplete thread engagement. As…
vehicle tether anchorFord Motor Company
VehicleOct 17, 2024
BMW cushion recall — NHTSA campaign 24V772000
BMW of North America, LLC (BMW) is recalling certain 2025 X3 xDrive30i and X3 M50i vehicles. The front passenger air bag fabric may have been damaged during transport between suppliers.
cushionBMW of North America, LLC
Medical DeviceOct 16, 2024
Becton Dickinson & Co BD Synapsys Informatics Solution with software versions: 4.20, 4.30 recall — FDA Z-0026-2025
Synapsys software versions 4.20, 4.30, 5.10, 5.20, or 5.30 and utilizing the in-line breakpoint feature, an error is occurring where BD Synapsys will incorrectly display breakpoints for…
Class IIFDA: OngoingBecton Dickinson & Co.
Medical DeviceOct 16, 2024
Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137 recall — FDA Z-0025-2025
When the DxI 9000 Access Immunoassay Analyzer with system software version 1.16.2 and prior is configured to automatically request a calibration order, the instrument can process the order…
Class IIFDA: OngoingBeckman Coulter, Inc.
Medical DeviceOct 16, 2024
Stryker Neurovascular The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft recall — FDA Z-0021-2025
Stryker Neurovascular has observed that devices with Out of United States (OUS) approved Instructions for Use (IFU) and Packaging Labels (pouch and carton), different configurations, have…
Class IIFDA: OngoingStryker Neurovascular
Medical DeviceOct 16, 2024
Luminex Molecular Diagnostics NxTAG Respiratory Pathogen Panel, REF: I051C0447 recall — FDA Z-0042-2025
Respiratory pathogen panel may report an elevated rate (7.6% predicted probability of occurrence) of non-specific hMPV target (human Metapneumovirus) results, risk identified predominantly…
Class IIFDA: OngoingLuminex Molecular Diagnostics Inc.
Medical DeviceOct 16, 2024
Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation (UAS) recall — FDA Z-0041-2025
Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.
Class IIFDA: OngoingInspire Medical Systems Inc.
Medical DeviceOct 16, 2024
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001 recall — FDA Z-0032-2025
It has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the initial few uses, as well as…
Class IIFDA: OngoingMEDLINE INDUSTRIES, LP - Northfield
Medical DeviceOct 16, 2024
AURIS HEALTH Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB recall — FDA Z-0052-2025
Endoscopy/bronchoscopy/urology devices may have a strain relief defect with some cart and tower power cords that may cause an electrical short, which may lead to system shutdown, which can…
Class IIFDA: OngoingAURIS HEALTH Inc.
Medical DeviceOct 16, 2024
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U recall — FDA Z-0033-2025
It has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the initial few uses, as well as…
Class IIFDA: OngoingMEDLINE INDUSTRIES, LP - Northfield
Medical DeviceOct 16, 2024
Windstone Medical Packaging Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the recall — FDA Z-0028-2025
Due to convenience kits containing a kit component that is under a recall action for improper use.
Class IIFDA: OngoingWindstone Medical Packaging, Inc.
Medical DeviceOct 16, 2024
Howmedica Osteonics Triathlon Universal TS Baseplate Size 2 - A single use sterile recall — FDA Z-0023-2025
Anterior locking tabs on the Triathlon Universal Baseplate are out of specification which may prevent engagement of either of the two locking tabs with the locking wire of the tibial insert.
Class IIFDA: OngoingHowmedica Osteonics Corp.
Medical DeviceOct 16, 2024
Windstone Medical Packaging Aligned Medical Tonsil Pack REF AMS14809 that contains the recall — FDA Z-0031-2025
Due to convenience kits containing a kit component that is under a recall action for improper use.
Class IIFDA: OngoingWindstone Medical Packaging, Inc.
Medical DeviceOct 16, 2024
Integra LifeSciences MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn recall — FDA Z-0054-2025
There is a potential for pinholes in the applicator pouch film which creates a sterility concern.
Class IIFDA: OngoingIntegra LifeSciences Corp.
Medical DeviceOct 16, 2024
Luminex Molecular Diagnostics NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468 recall — FDA Z-0043-2025
Respiratory pathogen panel may report an elevated rate (7.6% predicted probability of occurrence) of non-specific hMPV target (human Metapneumovirus) results, risk identified predominantly…
Class IIFDA: OngoingLuminex Molecular Diagnostics Inc.
Medical DeviceOct 16, 2024
MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT recall — FDA Z-0034-2025
It has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the initial few uses, as well as…
Class IIFDA: OngoingMEDLINE INDUSTRIES, LP - Northfield
Medical DeviceOct 16, 2024
Qualigen FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the recall — FDA Z-0022-2025
Thyroid Stimulating Hormone (TSH) calibrator card has an incorrect barcode linked to incorrect information, that may allow successful system calibration, but the TSH results obtained could…
Class IIFDA: OngoingQualigen Inc.
Medical DeviceOct 16, 2024
AURIS HEALTH Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R recall — FDA Z-0051-2025
Endoscopy/bronchoscopy/urology devices may have a strain relief defect with some cart and tower power cords that may cause an electrical short, which may lead to system shutdown, which can…
Class IIFDA: OngoingAURIS HEALTH Inc.
Medical DeviceOct 16, 2024
Windstone Medical Packaging Aligned Medical Tonsil Tray REF AMS9300A that contains the recall — FDA Z-0027-2025
Due to convenience kits containing a kit component that is under a recall action for improper use.
Class IIFDA: OngoingWindstone Medical Packaging, Inc.
Medical DeviceOct 16, 2024
Windstone Medical Packaging Aligned Medical T and A Pack REF AMS11482 that contains the recall — FDA Z-0030-2025
Due to convenience kits containing a kit component that is under a recall action for improper use.
Class IIFDA: OngoingWindstone Medical Packaging, Inc.
Medical DeviceOct 16, 2024
Medline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component ConMed/Unimax recall — FDA Z-0053-2025
CONMED Corporation (vendor) initiated a recall for select lot numbers of the Unimax Detachable Endo Pocket. The Detachable Endo Pocket is indicated for use as a receptacle for the…
Class IIFDA: OngoingMEDLINE INDUSTRIES, LP - Northfield
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.