The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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10301–10325 of 39932

  • HighFDA (Devices)·Z-1399-2023·2023-04-26

    Tobii Dynavox TD I-110 Speech Device Recalled Over Loose Battery Risk

    The FDA is recalling the Tobii Dynavox TD I-110, a speech-generating device, because the battery may become loose from its housing and potentially be damaged. This affects users worldwide who depend on this device for communication.

    Product
    Tobii Dynavox TD I-110 Speech Device-tablet style speech generating device used for ambulatory people with disabilities. Catalog #: 750567
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1394-2023·2023-04-26

    Radiometer AQURE Software Recall Due to Patient Mix-up Risk

    Radiometer is recalling AQURE laboratory software versions 2.5.2 through 2.6.1 due to a potential issue that could cause patient data mix-ups.

    Product
    AQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The AQURE system is intended to let you manage analytical devices and operator profiles. The user can associate patient data with test data. The system shows test results. The system receives data from…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1420-2023·2023-04-26

    Baxter ExactaMed Oral Dispenser Recalled for Particulate Matter Contamination

    Baxter Healthcare Corporation is recalling the ExactaMed 20 mL Oral Dispenser (Lot B301S356P) because it may contain particulate matter. The recall affects approximately 91,100 units distributed in the US.

    Product
    ExactaMed Oral Dispenser - 20 mL Clear Pharmacy Pack, REF H9387120; Oral medication syringe
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1414-2023·2023-04-26

    Samsung GM85 Digital X-ray Imaging System Arm Latch Failure

    NeuroLogica Corporation recalls 935 Samsung GM85 digital X-ray systems due to a faulty arm latch in the column support that could allow the arm to fall, creating a risk of bodily injury.

    Product
    Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1407-2023·2023-04-26

    Surgical Centurion CirClamp Recalled for Incorrect Subassembly Size

    Medline Industries is recalling 162 units of Centurion CirClamp surgical devices due to incorrect subassembly size. The defect could affect proper device function during surgical use.

    Product
    Centurion CirClamp with 1.3cm Bell & Insert Reprocessed, Reorder #CR230K, Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1402-2023·2023-04-26

    Medacta MectaLIF ANTERIOR spine implant recalled due to screw breakage risk

    Medacta USA is recalling MectaLIF ANTERIOR interbody fusion devices due to a potential for breakage of a small screw that secures the anti-backout plate. The defect affects 44 units distributed across five US states.

    Product
    MectaLIF ANTERIOR - Lag Plate Flush H14, REF 03.30.302, interbody fusion device
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1418-2023·2023-04-26

    Olympus Single-Use Endoscopic Clip Fixing Device Recalled for Deployment Failure

    Olympus is recalling single-use rotatable clip fixing devices used in endoscopy procedures. The clips may fail to deploy from the tube sheath during use.

    Product
    Single Use Rotatable Clip Fixing Device Model HX 201LR 135 - Rotatable, 165cm long, 2.8 scope channel, standard clip Model HX 201UR 135 - Rotatable, 230 cm long, 2.8 scope channel, standard clip Model HX 201UR 135L - Rotatable, 230 cm long, 2.8 mm scope channel, Long clip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1405-2023·2023-04-26

    Spinal fusion device antibackout screw may break, FDA recalls

    Medacta Usa Inc is recalling MectaLIF ANTERIOR antibackout lag covers due to potential breakage of the small screw that affixes the anti-backout plate. The defect affects spinal fusion procedures in select US states.

    Product
    MectaLIF ANTERIOR - Antibackout Lag Cover, REF 03.30.305, interbody fusion device
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1393-2023·2023-04-26

    Smith & Nephew Knee Implant Component Mispack: Wrong Size Distributed

    Smith & Nephew is recalling 12 JOURNEY II UNI Tibia Insert components due to a manufacturing mispack. Some boxes incorrectly contain a different size component.

    Product
    JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1404-2023·2023-04-26

    Interbody Fusion Device Recalled for Potential Screw Breakage

    Medacta's MectaLIF ANTERIOR fusion device is being recalled due to potential breakage of a small screw used to affix the anti-backout plate. The recall affects 17 units distributed across the US.

    Product
    MectaLIF ANTERIOR - Lag Plate Flush H18, REF 03.30.304, interbody fusion device
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1411-2023·2023-04-26

    Spinal Implant Screws Recalled for Defective Titanium Material

    Medtronic is recalling INFINITY spinal implant screws manufactured with incorrect titanium material. The defect reduces the screw's gripping strength, risking implant performance in critical spinal fusion surgery.

    Product
    INFINITY Occipitocervical Upper Thoracic System, PARTIALLY THREADED MULTI AXIAL SCREW, Size: 4.0mm x 22mm, REF 360PT4022; for immobilization and stabilization of spinal segment as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1415-2023·2023-04-26

    Laboratory diagnostic device software issue may delay clinical diagnosis

    BD Kiestra InoqulA+ (software versions 5.1/5.1.1) fails to display plate information after processing in clinical laboratories, risking diagnostic delays or specimen recollection.

    Product
    BD Kiestra InoqulA+ with BD Kiestra" InoqulA+" and BeA Software version 5.1 and 5.1.1 as part of the Icefall A platform. An in vitro diagnostic medical device intended to automate specimen processing according to user-defined procedures and protocols. Catalog (Ref) No.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1410-2023·2023-04-26

    Medtronic INFINITY Spinal Fusion Screws Recalled for Material Defect

    Medtronic is recalling 10 units of INFINITY Multi-Axial Screws distributed in the US and Canada because incorrect titanium material reduces gripping strength in affected lots.

    Product
    INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 32mm, REF 3604532; for immobilization and stabilization of spinal segment as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical unction, the cervical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1403-2023·2023-04-26

    FDA Recalls MectaLIF ANTERIOR Interbody Fusion Device Due to Screw Breakage Risk

    Medacta Usa Inc is recalling the MectaLIF ANTERIOR interbody fusion device due to potential breakage of the small screw that affixes the anti-backout plate. The recall affects 34 units distributed in the United States.

    Product
    MectaLIF ANTERIOR - Lag Plate Flush H16, REF 03.30.303, interbody fusion device
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1419-2023·2023-04-26

    Beckman Coulter Free T3 Reagent Test Kit Recalled for Falsely Elevated Results

    Beckman Coulter is recalling Access Free T3 reagent test kits (Catalog #A13422, Lot #233968) because approximately 15-20% of samples produce falsely elevated results that could lead to misdiagnosis and inappropriate thyroid treatment.

    Product
    Beckman Coulter Access Free T3, Triiodothyronine, Free, Catalog #A13422, each box contains 2 reagent packs.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1391-2023·2023-04-26

    KLS E-Coupling Adapter Recalled for Incorrect Product Identifier Code

    Pro-Dex Inc is recalling 199 KLS E-Coupling Adapter devices due to incorrect Unique Device Identifier (UDI) and GTIN codes. The devices were distributed nationwide.

    Product
    KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter Assembly used to connect the KLS driver (e.g. drill) to a driver bit that fits into the adapter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1406-2023·2023-04-26

    Avanos Ballard Oral Care Swabs recalled for incorrect expiration date labeling

    Avanos Medical is recalling Ballard Oral Care Swabs (codes 12241, 12243, 12251) due to incorrect expiration date labeling. The recall affects 5,475 cases distributed worldwide.

    Product
    Avanos Ballard Oral Care Swab, Bulk Packed, Product Codes: a) 12241, b) 12243, c) 12251
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1396-2023·2023-04-26

    VITROS COVID-19 Antibody Test Calibrators Recalled for Incorrect Calibrator Levels

    Ortho-Clinical Diagnostics is recalling VITROS Anti-SARS-CoV-2 Total N Antibody Calibrators used in COVID-19 testing due to incorrect calibrator levels in Assay Data Disks, which can delay patient test results.

    Product
    VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody Calibrators programmed onto the Assay Data Disks (ADD) Data Release Versions (DRV): DRVs 6213 through 6218 supporting VITROS Calibrators. Product Code: 6199976
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1408-2023·2023-04-26

    Medtronic SenSight Extension Tunneler Kit: manufacturing defect prevents dual-extension passage

    Medtronic recalled approximately 1414 SenSight Extension Tunneler Kits due to a manufacturing defect where dual carriers were machined on only one side, preventing use for passing two extensions simultaneously.

    Product
    Medtronic SenSight Extension Tunneler Kit, REF B31030; The Extension Tunneler Kit is used to assist in the tunneling and passage of extensions for deep brain stimulation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1398-2023·2023-04-26

    Pressure Therapy System Recalled for Unauthorized Deep Vein Thrombosis Prevention Claim

    Compass Health Brands is recalling the REX Pressure Therapy System because the user manual incorrectly claims the device can prevent deep vein thrombosis, an indication for which the device was not FDA-cleared.

    Product
    REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual. Intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. Models: DVTREX-U and DVTREX -L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1313-2023·2023-04-19

    Ivenix Large Volume Infusion Pump Recalled Due to Fluid Ingress Risk

    Fresenius Kabi is recalling the Ivenix Infusion System Large Volume Pump (Model LVP-0004) because fluid ingress can damage the device, causing loss of electrical function and preventing or halting infusion.

    Product
    Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1350-2023·2023-04-19

    First Response Easy Read App unable to reliably read pregnancy test results

    Church & Dwight's Easy Read App for pregnancy test sticks may fail to display test results or misread them, leading to false positive or false negative results. The app was marketed without required FDA clearance.

    Product
    Easy Read App associated with First Response Pregnancy Test Sticks - Intended use of converting analog pregnancy test results into text pregnant or not pregnant for display on consumer devices (e.g., smart phone, iPad)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1363-2023·2023-04-19

    Inflatable Penile Prosthesis Risk of Premature Pump Failure

    Coloplast's Titan Touch NB Scrot Zero 16cm prosthesis has been recalled due to decreased wall thickness that could cause premature pump failure. The defect was identified in specific lot units distributed worldwide.

    Product
    Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1386-2023·2023-04-19

    Stryker MAKO RESTORIS tibial baseplate trial recalled for incorrect size marking

    Stryker is recalling 102 units of MAKO RESTORIS MultiCompartmental Knee tibial baseplate trials with incorrect size laser markings. Wrong markings could lead to selection of incorrect implant sizes during partial knee replacement surgery.

    Product
    stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty surgical procedure
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1385-2023·2023-04-19

    Knee implant trial components recalled for incorrect size laser markings

    Stryker MAKO RESTORIS MCK tibial baseplate trial components used in knee surgery contain incorrect laser markings indicating component size. This affects 52 units distributed internationally and could lead to implantation of wrong-sized components during surgery.

    Product
    stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee Arthroplasty surgical procedure
    Category
    Medical Device
    Distribution
    0 states