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 deaths or serious injuries are reported, 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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4251–4275 of 13526

  • HighFDA (Devices)·Z-0762-2025·2025-01-01

    MISHA Knee System Implants recalled due to fracture risk

    Moximed is recalling 115 MISHA Knee System Implants in multiple US states due to a supplier component defect that may cause the implant to fracture, potentially leading to pain, swelling, and stiffness.

    Product
    MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Implant Small, Right, REF: 2-1002.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0748-2025·2025-01-01

    BD FACSLyric Flow Cytometer Power Supply Module Failure Risk

    BD is recalling power supply modules on FACSLyric flow cytometers that may fail to power on or stay on. Failure could cause lab staff to inhale fumes and patients to need repeat blood draws.

    Product
    FACSLyric 3L10C Instrument US-IVD, Catalog Number 662878, UDI 00382906628787 The K170974 clearance document describes the device as follows: The BD FACSLyric" flow cytometer (3-1, 4-2, 4-2-2, and 4-3-3 optical configurations) systems consist of a flow cytometer, sheath ta
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0749-2025·2025-01-01

    BD FACSLyric Flow Cytometer Power Supply Failure Risk

    BD is recalling FACSLyric flow cytometer power supplies that may fail to power on or stay on, creating risks of fume inhalation and requiring patients to return for repeat biospecimen collection procedures.

    Product
    FACSLyric 3L12C Instrument RUO, Catalog Number 663518, UDI 00382906635181
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0719-2025·2025-01-01

    Surgical Patties and Strips Recalled for Endotoxin Contamination

    Medline Industries recalls DIEP FLAP Convenience kits containing surgical patties and strips due to higher-than-expected endotoxin contamination that may not meet sterile product specifications.

    Product
    DIEP FLAP Convenience kit, SKU DYNJ910120. Convenience kits used for various procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0752-2025·2025-01-01

    FDA Recalls Medical Spine Component Due to Manufacturing Defects

    SEASPINE Orthopedics is recalling 191 Daytona Small Stature Ti Locking Caps due to manufacturing defects that prevent proper component mating.

    Product
    Brand Name: Daytona Small Stature Product Name: Ti Locking Cap 4.5mm, Small Stature, T25 Model/Catalog Number: 79-0001 Software Version: N/A Product Description: Locking Cap Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0736-2025·2025-01-01

    Siemens epoc Blood Analysis System Recalled for Patient Identification Software Error

    Siemens is recalling epoc NXS Host blood analysis systems due to a software malfunction that can assign incorrect patient names to test results, potentially leading to misdiagnosis and mistreatment if not verified by the user.

    Product
    epoc NXS Host; Siemens Material Number (SMN): 11413498(JP) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0756-2025·2025-01-01

    Medline Surgical Needle Holders Recalled for Sterility Compromise

    Medline is recalling 21,440 surgical needleholders due to weak seals that may compromise sterility and increase risk of contamination and infection during surgical use.

    Product
    ST OR MAYO HEGAR NEEDLEHOLDER 6"(OR2500), Medline Item No. 67870
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0727-2025·2025-01-01

    Cardiac troponin test reagent recalled for potential false results

    Beckman Coulter recalls 2.1 million units of Access hsTnI reagent worldwide due to contamination causing falsely elevated troponin results in patient samples.

    Product
    Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0734-2025·2025-01-01

    Blood Analysis System Recalled Due to Patient Name Assignment Software Error

    Siemens is recalling the epoc NXS Host blood analysis system due to a software defect that can incorrectly assign patient names to test results, potentially causing misdiagnosis and mistreatment.

    Product
    epoc NXS Host; Siemens Material Number (SMN): 11413475 (US); Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capill
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0758-2025·2025-01-01

    Medline Reprocessed Bruns Curette Surgical Instruments Recalled for Weak Sterile Seals

    Medline is recalling 21,440 reprocessed Bruns curettes due to weak sterile seals that may fail without user detection. This increases the risk of contamination and infection.

    Product
    ST REPROCESSED BRUNS CURETTE #00 (BC00), Medline Item No. 67600K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0722-2025·2025-01-01

    Surgical Patties and Strips Recalled for Elevated Endotoxin Levels in Kits

    Medline Industries is recalling SEPTOPLASTY PACK convenience kits nationwide due to higher-than-expected endotoxin levels in surgical patties and strips. The contamination may pose infection risks during surgical procedures.

    Product
    SEPTOPLASTY PACK Convenient kit, SKU DYNJ44759F. Convenience kits used for various procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0694-2025·2025-01-01

    Panther Fusion Assay Kit Recalled for Possible SARS-CoV-2 False Positives

    Hologic is recalling specific lots of the Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay due to potential false positive SARS-CoV-2 results. Users should verify positive results with an alternative testing method.

    Product
    Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0738-2025·2025-01-01

    Siemens Blood Analysis System Software Malfunction May Cause Patient Identification Error

    Siemens epoc NXS Host blood analysis systems are recalled due to a software malfunction that can assign incorrect patient names to blood tests, potentially leading to misdiagnosis or mistreatment.

    Product
    epoc NXS Host; Siemens Material Number (SMN): 11413517(MX) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0767-2025·2025-01-01

    Siemens magnesium reagent cartridges recalled for false measurement results

    Siemens is recalling two lots of Magnesium Flex reagent cartridges due to potential falsely low magnesium measurements. The intermittent error may not be detected by standard quality control procedures.

    Product
    Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0732-2025·2025-01-01

    Abbott Vascular Inflation Device May Leak During Cardiovascular Procedures

    Abbott Vascular is recalling the 20/30 Priority Pack Accessory Kit w/Copilot inflation device used in cardiovascular procedures because it may leak at connection points, potentially causing air embolism.

    Product
    20/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, used for cardiovascular procedures.
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-0731-2025·2025-01-01

    Abbott Vascular inflation device may leak during cardiovascular procedures

    Abbott Vascular is recalling 20/30 Priority Pack Accessory Kit inflation devices due to potential leaks that could cause air embolism during cardiovascular procedures.

    Product
    20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascular procedures in conjunction with interventional and / or diagnostic devices (e.g., balloon dilatation catheters, atherectomy devices, stent delivery systems, intravascular ultrasound devices).
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-0741-2025·2025-01-01

    Siemens epoc blood analyzer software assigns incorrect patient names

    Siemens epoc NXS blood analysis system has a software defect that can incorrectly assign patient names to blood test results, potentially causing misdiagnosis or mistreatment.

    Product
    epoc NXS Host; Siemens Material Number (SMN): 11413879(IN) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0742-2025·2025-01-01

    Galaxy System bronchoscope power supply defect may injure lung tissue

    Noah Medical's Galaxy System bronchoscope has defective power supply semiconductors that may fail during procedures, potentially causing pneumothorax or lung tissue injury when the scope is manually removed.

    Product
    Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-0757-2025·2025-01-01

    Sterile Magill Forceps Recalled Due to Weak Seals and Contamination Risk

    Medline has recalled Sterile Magill Forceps (Item No. 66790) due to weak seals that may compromise sterility. The defect affects approximately 21,440 units distributed nationwide.

    Product
    STERILE MAGILL FORCEP (MAGF9), Medline Item No. 66790
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0725-2025·2025-01-01

    Surgical Patties and Strips with Endotoxin Contamination in Medline Convenience Kits

    Medline Industries is recalling surgical patties and strips in specific lots of KIT,SPINE LH Convenience Kits due to higher-than-expected endotoxin levels in raw materials. The contamination may result in out-of-specification endotoxin in finished sterile products.

    Product
    KIT,SPINE LH Convenience kit, SKU DYNJ906448A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0761-2025·2025-01-01

    EMPOWR 3D Knee Tibial Insert Recalled for Wrong Product in Package

    Encore Medical is recalling 9 units of EMPOWR 3D Knee Tibial Insert (Lot 076T1273A) because packages may contain an acetabular system instead of the intended knee insert, potentially causing surgical delays.

    Product
    EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0729-2025·2025-01-01

    O&M Halyard Surgical Masks Recalled for Failing Bioburden Testing

    O&M Halyard SOFT TOUCH II Surgical Masks (lot AM4119961) are being recalled for not meeting EN 14683 bioburden testing standards printed on the packaging. No illnesses or injuries have been reported.

    Product
    O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask Product Code: 47500
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0769-2025·2025-01-01

    Hip Reconstruction System Component Mislabeled for Size

    Waldemar Link is recalling 3 units of the LINK MP Reconstruction System Neck Segment due to a labeling error indicating the wrong size (XXL instead of standard), though all other specifications on the labels are correct.

    Product
    LINK MP Reconstruction System Neck Segment (with suture holes, standard, uncemented, L= 35 mm, CCD 126¿, Offset= 31 mm, Ti6Al4V, PoroLink, Taper 12/14. Item Number: 99-0984/32 Intended for revision hip arthroplasty in patients whose bone stock is of poor quality or inadeq
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0750-2025·2025-01-01

    BYTE Aligner System Recalled for Virtual-Only Approval Workflow Gaps

    Straight Smile LLC is recalling BYTE Aligner systems due to a virtual-only clinical workflow that may not adequately screen patients with contraindications for aligner use. Approximately 5.3 million devices are affected.

    Product
    BYTE Aligner System REF PRS-0063 BYTE All-Day Aligner System BYTE AT-Night Aligner System A custom-made orthodontic appliance, typically supplied in series intended to be worn in succession and self-changed every few weeks, designed to influence the shape and/or function o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0658-2025·2024-12-25

    Walcott Bipolar Pencil Surgical Instrument Recalled for Potential Tube Detachment

    Kirwan Surgical Products is recalling Walcott Bipolar Pencil 25 Gauge surgical instruments due to potential breakage or detachment of the stainless-steel tube. The affected pencils are used in eye and soft tissue surgery.

    Product
    Walcott Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: RX14-5011. Product Description: The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization of the re
    Category
    Medical Device
    Distribution
    Distributed nationwide