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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11951–11975 of 13802

  • HighFDA (Devices)·Z-0931-2022·2022-04-20

    Siemens Atellica CH Lithium reagent recalled for potential reagent carryover

    Siemens Healthcare Diagnostics recalls approximately 2,158 units of Atellica CH Lithium_2 reagent (Lot Numbers 110108, 110185, 110238, 110302) due to potential for reagent carryover affecting quality control results, patient samples, and calibrator results.

    Product
    Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11097637
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0939-2022·2022-04-20

    Cardiac electrode fails electrical safety test; defibrillation may not work

    The CLARAVUE Pre-wired Electrode does not meet electrical safety standards for defibrillators. It may not deliver effective electrical charge during emergency defibrillation.

    Product
    CLARAVUE Pre-wired Electrode - IP SET 6V RT ADULT-US Model: 32028780 50603-US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0923-2022·2022-04-20

    Abbott Vascular Cardiovascular Device Recalled for Leaks and Loose Connections

    Abbott Vascular is recalling the 20/30 Priority Pack w/COPILOT device due to an increase in complaints of leaks and loose connections. The recall affects 131 lots distributed nationwide and internationally.

    Product
    20/30 Priority Pack w/COPILOT - REF 1003327 WPL2122272-01 (2019-03-01)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0920-2022·2022-04-20

    Verigene Processor SP Recalled for No Call Results

    Luminex Corporation is recalling 4 Verigene Processor SP diagnostic devices that repeatedly failed to produce results, returning No Call outputs instead. Two of three customer complaints involved this malfunction.

    Product
    Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0903-2022·2022-04-20

    Access-9 Hemostasis Valves Recalled for Guidewire Entrapment Risk

    Merit Medical Systems is recalling 36,445 Access-9 Large Bore Hemostasis Valves due to an internal gap that can trap the guidewire, potentially delaying medical procedures.

    Product
    Access-9 Large Bore Hemostasis Valves, Catalog Code: 580775001, IN8112/C, K05-00053H, K05-00109G, K05-00137K, K05-00410G, K05-00438G, K05-00502F, K05-00587D, K05-01052, K05-01706C, K05-01880K, K05-02130, K05-02595, K09-12599A, K10-05487P, K12-00264, MAP111/F, MAP112/B, MAP112/F,
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-0915-2022·2022-04-20

    Boston Scientific ROTAWIRE Drive guide wire devices recalled for open pouch seals

    Boston Scientific is recalling ROTAWIRE Drive and ROTAWIRE Drive Floppy guide wire devices because pouch seals may be open, compromising sterility. The recall affects 433 5-packs distributed in the US, territories, Japan, and Canada.

    Product
    ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0914-2022·2022-04-20

    Orthopedic surgical driver oversized, affecting hammertoe correction

    Nextremity Solutions is recalling the Nextra Hammertoe Correction System Driver (SKU: NX-DR) due to oversizing at the proximal end, which impairs connection and removal from the implant, causing surgical delays. The defect affects 239 units distributed in the US, Japan, and the Netherlands.

    Product
    Nextra Hammertoe Correction System Driver SKU: NX-DR Orthopedic surgical instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0873-2022·2022-04-20

    Hemodialysis Conductivity Sensors recalled for potential cracks and dialysate leaks

    B Braun Medical Inc is recalling conductivity sensors used in Dialog hemodialysis systems due to potential cracking during use, which could cause leaks in the dialysate circuit and improper ultrafiltration. Affected patients should contact their healthcare provider.

    Product
    Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (END) - VERSION 2, Article Code Number 3456103A. These conductivity sensors may be used as spare parts for the following dialysis machines: 710200L (UDI 04046963686345), 710200S (UDI 0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0872-2022·2022-04-20

    Conductivity Sensors in Dialog Hemodialysis Systems May Crack and Leak

    B Braun Medical Inc is recalling conductivity sensors used in Dialog and Dialog+ hemodialysis systems due to potential cracks that could cause dialysate circuit leaks, affecting ultrafiltration during treatment.

    Product
    Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (BIC) - VERSION 2, Article Code Number 3456102A. These conductivity sensors may be used as spare parts for the following dialysis machines: 710200L (UDI 04046963686345), 710200S (UDI 0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0904-2022·2022-04-20

    AccessPLUS hemostasis valves recalled for internal guidewire entrapment risk

    Merit Medical is recalling AccessPLUS Large Bore Hemostasis Valves due to an internal design gap that can trap guidewires, potentially delaying medical procedures.

    Product
    AccessPLUS Large Bore Hemostasis Valves, Catalog Code: 580758001, 580774001, IN8152/C, K04-01197, K05T-01863, K09-09102B, K09-10388A, K09-12917, K09-13501AP, K10-05457AP, K10-05635, K10-05868P, K10-05872P, K12-08303, K12-10346, K12-10375, K12-10724AP, K12-10962, K12-11413, MAP150
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-0922-2022·2022-04-20

    FDA Recalls Abbott Vascular Priority Pack Accessory Kits for Leak and Connection Issues

    Abbott Vascular is recalling 23 lots of Priority Pack accessory kits and packs due to reports of leaks and loose connections in the devices.

    Product
    20/30 Priority Pack Accessory Kit/.096 RHV - REF 1000186 WPL2122270-01 (2019-03-01) 20/30 Priority Pack w/.115 RHV - REF 1000186-115 WPL2122270-02 (2019-03-01)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0928-2022·2022-04-20

    Siemens Atellica CH Calcium_2 Reagent Carryover Recall

    Siemens is recalling Atellica CH Calcium_2 diagnostic reagent due to potential reagent carryover that could impact quality control, patient samples, and calibrator results. The recall affects approximately 2,395 units distributed globally and in the US.

    Product
    Atellica CH Calcium_2 (CA_2), Siemens Material Number 11097644
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0943-2022·2022-04-20

    Ventilator trolley mounting brackets can detach and cause device to fall

    The mounting brackets on Breas Ventilator Trolleys can become detached, allowing ventilators to fall. This poses an injury risk to people near the equipment.

    Product
    Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models Article no 007384
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0938-2022·2022-04-20

    Pre-wired ECG Electrode Set Fails Defibrillation Voltage Safety Standard

    Graphic Controls' CLARAVUE Pre-wired Electrode set does not meet required electrical specifications for defibrillation use. The device fails to withstand 5,000 volts without breakdown, potentially resulting in ineffective defibrillation.

    Product
    CLARAVUE Pre-wired Electrode - IP SET 12 RT ADULT-US Model: 32028779 50602-US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0941-2022·2022-04-20

    Medline Laryngeal Masks recalled due to potential cuff disconnection

    Medline Industries is recalling approximately 8,990 cases of Standard PVC Laryngeal Masks distributed nationwide because the mask cuff may disconnect from the breathing tube.

    Product
    Medline Standard PVC Laryngeal Masks, 1 device per pouch, 5 each pouches per box
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0925-2022·2022-04-20

    Abbott Vascular Plus 30 Priority Pack Recalled for Connection Leaks

    Abbott Vascular is recalling seven lots of the Plus 30 Priority Pack due to increased reports of leaks and intermittent loose connections in the vascular devices.

    Product
    Plus 30 Priority Pack w/.096 RHV - REF 1000183 WPL2122277-01 (20-03-01) Plus 30 Priority Pack w/.115 RHV - REF 1000185-115 WPL2122279-01 (2019-03-01)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0921-2022·2022-04-20

    Abbott Vascular 20/30 Indeflator Recalled for Leaks and Connection Failures

    Abbott Vascular recalls 20/30 Indeflator medical devices due to increased complaints of leaks and loose connections. The recall affects 17 product lots distributed nationwide and internationally.

    Product
    20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0919-2022·2022-04-20

    MUSE Cardiology System edits and diagnosis data lost after test signed

    GE Healthcare's MUSE Cardiology Information System may lose test measurement edits and diagnosis statements after signing. The Class II recall affects 147 units in the US and internationally.

    Product
    MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c) 3101010-009, d) 3101010-008
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0913-2022·2022-04-20

    Hammertoe Correction Surgical System Recalled for Driver Connection Defect

    Nextremity Solutions recalls the Nextra Hammertoe Correction System because the driver's proximal end is oversized, making it difficult to connect and remove from the implant, potentially delaying surgery.

    Product
    Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut SKU: NX-3532K-SC Orthopedic surgical instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0937-2022·2022-04-20

    CLARAVUE Pre-wired Electrode fails to meet electrical safety specification

    Graphic Controls' CLARAVUE Pre-wired Electrode units fail to meet electrical safety specifications required for defibrillation. The device delivers an inefficient electrical charge and may result in ineffective defibrillation.

    Product
    CLARAVUE Pre-wired Electrode - IP SET M5 RT ADULT-US Model: 32028778 50601-US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0929-2022·2022-04-20

    Siemens Atellica CH Hemoglobin A1c Reagent Kits Recalled for Quality Control Issues

    Siemens Healthcare is recalling Atellica CH Hemoglobin A1c reagent kits due to potential reagent carryover affecting quality control and patient test results. The issue may cause inaccurate diabetes monitoring measurements.

    Product
    Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 11097536
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0911-2022·2022-04-20

    Nextra Hammertoe Correction System surgical instruments recalled for defective connector

    Nextremity Solutions recalls 459 units of the Nextra Hammertoe Correction System due to an oversized proximal driver end that prevents proper connection and removal during surgery.

    Product
    Nextra Hammertoe Correction System 4.5 Middle and 3.2 Proximal Saw Cut SKU: NX-4532K-SC Orthopedic surgical instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0917-2022·2022-04-20

    FDA Recalls Touch Screen Modules for IVUS Imaging Systems

    Volcano Corp is recalling MM-TSM touch screen modules used with IntraSight Integrated IVUS systems because they may crack or become damaged, potentially rendering the imaging equipment non-functional.

    Product
    MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102, used with IntraSight Integrated (Part Number: 797403) IVUS systems
    Category
    Medical Device
    Distribution
    50 states
  • ModerateFDA (Devices)·Z-0930-2022·2022-04-20

    Siemens Atellica CH Fructosamine Reagent Recalled for Potential Carryover

    Siemens Healthcare Diagnostics is recalling Atellica CH Fructosamine reagent (lots 211359, 211451) due to potential reagent carryover that could affect diagnostic test accuracy.

    Product
    Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0932-2022·2022-04-20

    Hydroxybutyrate Test Kits Recalled Due to Improper Storage

    Medline's Hydroxybutyrate LiquiColor Tests are recalled due to improper storage that may cause delayed test results. The recall affects 45 units distributed across 16 U.S. states.

    Product
    Hydroxybutyrate LiquiColor Tests - includes 3 bottles (1 of each size, 3mL, 8.5mL, and 50mL)
    Category
    Medical Device
    Distribution
    16 states