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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5501–5525 of 13512

  • HighFDA (Devices)·Z-2642-2024·2024-08-28

    Vial Decanter Medical Device Recalled for Compromised Sterile Packaging

    Microtek Medical Inc. recalls Vial Decanter units (REF 2006S) due to pin holes and tears in the sterile packaging film discovered during testing. Compromised sterile barriers could allow microbial contamination.

    Product
    Vial Decanter, REF 2006S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2681-2024·2024-08-28

    Alinity hq Analyzer May Generate Incorrect Blood Test Results

    Abbott's Alinity hq Analyzer has been recalled due to software issues that can produce incorrect blood cell counts and hemoglobin measurements in certain circumstances. No illnesses have been reported.

    Product
    Alinity hq Analyzer, REF: 09P68-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2582-2024·2024-08-28

    Spectrum Wireless Battery Modules fail to auto-document infusion status

    Spectrum Wireless Battery Modules may fail to send infusion status updates to hospital electronic medical records. The issue affects 17,377 units nationwide used with Spectrum V8 and IQ infusion pumps.

    Product
    Spectrum Wireless Battery Modules A/B/G/N, product code 36010, used with either of the following 35700BAX2 (Spectrum V8 infusion pump) and 3570009 (Spectrum IQ infusion pump)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2665-2024·2024-08-28

    Ophthalmic knives recalled for insufficient sharpness in surgical instruments

    Alcon is recalling specific ophthalmic knives due to an increase in complaints regarding insufficient sharpness. Affected units may not perform as intended during surgical procedures.

    Product
    Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE2.6MM ANG DUAL Model/Catalog Number: 8065992647 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2645-2024·2024-08-28

    ClearCut S Safety Sideport Knife Recalled for Decreased Sharpness

    Alcon Research LLC is recalling ClearCut S Safety Sideport Knife ophthalmic surgical instruments due to reports of decreased sharpness. Affected units may not perform as intended during eye surgery.

    Product
    Product Name: ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2668-2024·2024-08-28

    Ophthalmic Knives Recalled for Sharpness Defects

    Alcon recalls A-OK ophthalmic knives for sharpness defects. Approximately 30,268 units distributed nationwide and internationally are affected.

    Product
    Product Desc: Product Name: A-OK SATINSLIT FULL HANDLE2.75MM ANG SG Model/Catalog Number: 8065992761 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2647-2024·2024-08-28

    Alcon ophthalmic surgical knives recalled for sharpness and performance degradation

    Alcon is recalling surgical instrument packs that include ClearCut and A-OK brand ophthalmic knives due to increasing complaints about sharpness loss. The affected knives could impact surgical precision during eye procedures.

    Product
    Product Name: 25+ TTL PLUS VPAK 20000CPM BWV Model/Catalog Number: 8065830077 Software Version: N/A Product Description: Standardized assemblage of components, which includes the valved trocar entry system, that interface with the CONSTELLATION Vision System. Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2641-2024·2024-08-28

    Bottle Decanter REF 2004S Recalled for Sterile Barrier Packaging Defects

    Microtek Medical Inc. is recalling Bottle Decanter REF 2004S units due to pin holes and tears found in the sterile barrier packaging during testing. Compromised packaging could allow contamination of the medical device.

    Product
    Bottle Decanter, REF 2004S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2657-2024·2024-08-28

    ClearCut Sideport Ophthalmic Knives Recalled Due to Sharpness Issues

    Alcon has recalled ClearCut Sideport Knife ophthalmic surgical instruments due to an increase in complaint reports related to sharpness.

    Product
    Product Desc: Product Name: ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2644-2024·2024-08-28

    Medical Device Recall: Ventana Anti-CD10 Antibody May Produce False Positive Results

    Ventana Medical Systems recalls its anti-CD10 (SP67) rabbit monoclonal antibody due to potential high background and off-target staining that could produce false positive test results. Approximately 22,839 kits distributed worldwide are affected.

    Product
    Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2698-2024·2024-08-28

    Medline Med-Soft Liners Recalled for Potential Fitting Difficulty

    Medline Industries is recalling approximately 35,900 Med-Soft Liners due to a dimensional variation that could make them difficult to fit into the outer canister. No injuries have been reported.

    Product
    1,5L MED-SOFT LINER W/ 6MMX3M TUB. & ADULT VC, REF OR53929
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2648-2024·2024-08-28

    Alcon ophthalmic surgical knives recalled for blade sharpness defects

    Alcon is recalling specific ophthalmic surgical knives (ClearCut and A-OK models) from its Custom Pak system due to blade sharpness complaints affecting 384,851 units distributed nationwide and internationally.

    Product
    Product Name: Alcon Custom Pak Model/Catalog Number: Many Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2715-2024·2024-08-28

    NeuroLogica GM60A Mobile X-Ray System Anti-Fall Arm Safety Failure Risk

    NeuroLogica has recalled its GM60A Digital Diagnostic Mobile X-Ray System due to potential failure of the anti-fall safety system in the device arm. The recall affects 31 units distributed nationwide.

    Product
    GM60A. Digital Diagnostic Mobile X-Ray System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2685-2024·2024-08-28

    Regard Kit Decanters Recalled for Defective Sterile Packaging

    ROi CPS LLC is recalling 78 Regard Kits containing Microtek decanters due to pin holes and tears in sterile packaging that cannot be identified visually. Defective packaging could compromise the sterile barrier.

    Product
    Regard Kit containing the Microtek decanter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2677-2024·2024-08-28

    Ophthalmic Surgical Knives Recalled Due to Sharpness Complaint Reports

    Alcon is recalling ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance ophthalmic surgical knives (Model 8065752438) due to increased complaint reports about sharpness.

    Product
    Product Name: TOTAL PLUS,25+,10K VALVE WD Model/Catalog Number: 8065752438 Software Version: N/A Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2653-2024·2024-08-28

    Ophthalmic Surgical Knives Recalled for Potential Sharpness Issues

    Alcon is recalling specific ophthalmic knives following an increase in complaint reports related to sharpness. These surgical instruments are used in eye procedures.

    Product
    Product Desc: Product Name: CLEARCUT SAFETY INTREPID DB,2.4 Model/Catalog Number: 8065772465 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2675-2024·2024-08-28

    Ophthalmic surgical knives recalled due to reported sharpness defects

    Alcon is recalling specific ophthalmic surgical knives due to reported sharpness defects. The recall affects 3,791 units distributed nationwide and internationally.

    Product
    Product Name: 25+ CMB PAK 7.5CPM,V,STD 0.9 Model/Catalog Number: 8065751767 Software Version: N/A Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2669-2024·2024-08-28

    Alcon Ophthalmic Surgical Knives Recalled Over Reported Sharpness Issues

    Alcon is recalling 11,676 ophthalmic surgical knives due to increased reports of sharpness defects. Affected units were distributed nationwide and internationally.

    Product
    Product Desc: Product Name: CLEARCUT SATINSLIT FULL HANDLE3.0MM ANG Model/Catalog Number: 8065993045 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2682-2024·2024-08-28

    BIOFIRE FILMARRAY Pneumonia Panel Recalled for Manufacturing Defect

    BioFire Diagnostics is recalling 58 units of BIOFIRE FILMARRAY Pneumonia Panel due to a manufacturing defect that increases the risk of control failures and delayed test results.

    Product
    BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2678-2024·2024-08-28

    Alcon ophthalmic surgical knives recalled for sharpness defects

    Alcon is recalling ClearCut and A-OK ophthalmic surgical knives due to sharpness complaints. The defect affects 1,057 units distributed nationwide and internationally.

    Product
    Product Name: 25+ CMB PAK 10K CPM,V,STD 0.9 Model/Catalog Number: 8065752450 Software Version: N/A Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2711-2024·2024-08-28

    Medline neuro procedure kits recalled for dimensional fitting variation

    Medline is recalling 2,013 medical procedure kits due to a slight dimensional variation that may cause difficulty fitting into the outer canister. No injuries reported.

    Product
    Medline medical procedure kits labeled as follows: a) BASIC NEURO, REF DYNJ909171A; b) NEURO, REF DYNJ905510D; c) NEURO, REF DYNJ902388L; d) NEURO SAS, REF DYNJ908566
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2671-2024·2024-08-28

    Ophthalmic Surgical Knives Recalled Due to Sharpness Defect

    Alcon is recalling 7,713 units of ClearCut and A-OK ophthalmic surgical knives due to reports of decreased sharpness. The defect may compromise surgical performance during eye procedures.

    Product
    Product Name: 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU Model/Catalog Number: 8065000095 Software Version: N/A Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2662-2024·2024-08-28

    Alcon recalls ClearCut ophthalmic knives due to sharpness issues

    Alcon is recalling approximately 11,916 ClearCut SB Intrepid 2.2 ANG ophthalmic knives due to complaints about blade sharpness. The affected units were distributed nationwide and internationally.

    Product
    Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Number: 8065992245 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2651-2024·2024-08-28

    Ophthalmic knives recalled for sharpness defects in ClearCut Safety Intrepid DB

    Alcon is recalling 1,152 ClearCut Safety Intrepid DB 2.2 ophthalmic knives (Model 8065772265) due to complaint reports of sharpness defects.

    Product
    Product Desc: Product Name: CLEARCUT SAFETY INTREPID DB,2.2 Model/Catalog Number: 8065772265 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2693-2024·2024-08-28

    IBA Proton Therapy System PROTEUS 235 Collision Detection Malfunction

    FDA recalls 19 units of the IBA Proton Therapy System PROTEUS 235 due to occasional failures in collision detection for the Forte Robotic Patient Positioning System affecting facilities across multiple US states and internationally.

    Product
    IBA Proton Therapy System - PROTEUS 235- Designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation
    Category
    Medical Device
    Distribution
    9 states