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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10226–10250 of 27470

  • HighFDA (Devices)·Z-0738-2022·2022-03-16

    FDA Recalls Diagnostic Test Strips for False Positive Results

    NeuMoDx COVID-19 test strips (Lot 116305 S/L-02) are recalled due to product contamination that increases risk of false positive results. The recall affects 102 boxes distributed in FL, MD, MI, and NY.

    Product
    NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed under EUA202947). Distributed in boxes of 6 assay strips in individual pouches. Box, pouch and strips all labeled with product name, ref #, lot #, and expiration date.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0733-2022·2022-03-16

    ExacTrac Dynamic Software Yaw Angle Error May Affect Radiotherapy Positioning

    ExacTrac Dynamic radiotherapy positioning software (versions 1.0.0–1.0.3) may calculate incorrect yaw angle for patient positioning with Varian linear accelerators, potentially affecting cone-beam CT imaging setup accuracy during radiotherapy.

    Product
    ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-01A, ETD Positioning and Moni. 1.0.1 INST; 20910-01B, ETD Positioning and Moni. 1.0.2 INST; and 20910-01C ETD Positioning and Moni. 1.0.3 INST.
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Devices)·Z-0735-2022·2022-03-16

    Laboratory diagnostic tips recalled for potential dispensing errors

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry VersaTips due to shape deformity that may reduce sample volume by 16%. Undetected errors could result in inaccurate test results for bloodborne infectious disease assays.

    Product
    VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0747-2022·2022-03-16

    Proton Therapy Systems May Fail to Verify Beam Range After Pause

    Proton therapy systems from Ion Beam Applications may not verify that beam range settings remain unchanged after treatment pause, risking incorrect treatment delivery if the range was manually modified.

    Product
    ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation Proteus 235
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-0729-2022·2022-03-16

    Vascular Graft Mislabeled; Packaging Labels Do Not Match Product Specifications

    A vascular graft has been recalled due to labeling mismatch: the outer package label differs from the inner sterile packaging in graft type and dimensions. Implanting the wrong size could disrupt blood vessel connections and create a pseudo-aneurysm.

    Product
    HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT- D: 7 mm; L: 60 cm Indicated for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease. Product Code/REF Number: M002020952070
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0741-2022·2022-03-16

    FISH Diagnostic Probe Kit Color Labeling Error Affects Test Results

    Cytocell Ltd. is recalling a Del(5q) Deletion FISH Probe Kit due to incorrect color labeling on probe components. The mislabeling may cause misinterpretation of test results for patients with AML or MDS.

    Product
    Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients with AML or MDS Catalog Number: USA-LPH024
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0725-2022·2022-03-16

    Philips X-ray System Cooling Leak Poses Fire Risk

    Philips Allura CV20 X-ray systems with certain Laird chillers may leak cooling liquid onto electrical components, potentially causing fire or smoke. Affected systems should not be operated until the issue is addressed.

    Product
    Philips Allura CV20 Interventional Fluoroscopic X-ray System products with a Laird chiller without an extended drip tray: Model Number: 722031
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0746-2022·2022-03-16

    PCA 4000 Dental Curing Units May Not Fully Cure Resins

    Envisiontec is recalling 172 PCA 4000 curing units that may not properly cure dental resins to specification (SKU ACC-06-1000).

    Product
    PCA 4000 Curing Units, SKU number ACC-06-1000 The PCA 4000 is used for curing industrial resins as well and this recall will not impact units sold to industrial customers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0743-2022·2022-03-16

    Medtronic endotracheal tubes recalled due to manufacturing nonconformity

    Medtronic Xomed is recalling over 301,000 NIM TRIVANTAGE EMG Endotracheal Tubes due to a manufacturing nonconformity. These devices were distributed worldwide.

    Product
    NIM TRIVANTAGE EMG Endotracheal Tube
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0732-2022·2022-03-16

    Radiation therapy planning software displays wrong images during animation playback

    RayStation/RayPlan versions 6.0.0.24 through 9.2.0.483 incorrectly display selected images as both primary and secondary when animation playback is running, affecting treatment planning visualization.

    Product
    RayStation/RayPlan- designed for treatment planning and analysis of radiation therapy. Software Version: 6.0.0.24 , 6.1.0.26 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6 , 7.0.0.19 , 8.0.0.61 , 8.0.1.10 , 8.1.0.47 , 8.1.1.8 , 8.1.2.5 , 9.0.0.113 , 9.1.0.933 , 9.2.0.483 . Includi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0722-2022·2022-03-16

    Diagnostic Testing Plates Recalled for Inaccurate Antibiotic Susceptibility Results

    Remel Inc is recalling 1210 Thermo Sensititre Gram Negative Testing Plates due to inaccurate susceptibility results that could affect antibiotic resistance testing.

    Product
    Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0728-2022·2022-03-16

    Stryker Camera Control Unit Recalled Due to Inverted Image Display Defect

    Stryker is recalling the 1688 Camera Control Unit due to a software defect that causes the surgical monitor image to flip upside-down. This could lead to surgeon error or the need for additional surgical intervention.

    Product
    1688 Camera Control Unit (CCU), Catalog number:1688010000. Used in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope/endoscope/arthroscope/sinuscope is used.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0724-2022·2022-03-16

    Philips Allura Xper X-ray systems cooling system leak poses fire risk

    Philips Allura Xper interventional X-ray systems may experience cooling liquid leaks that could drip on electrical components, creating risk of fire, smoke, or burning odors. No injuries have been reported.

    Product
    Philips Allura Xper, UNIQ(Allura Xper system-China) Interventional Fluoroscopic X-ray System products with a Laird chiller WITHOUT an extended drip tray: Model Number: 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0740-2022·2022-03-16

    Surgical hammertoe instruments recalled for potential locking mechanism deformation

    The Nextra Cannulated Hammertoe Standard Instrument Kit's driver may deform the implant locking mechanism during insertion, potentially requiring revision surgery.

    Product
    Nextra Cannulated Hammertoe Standard Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toe SKU: CH-STD-KT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0727-2022·2022-03-16

    B. Braun dispensing pins recalled for air filter leakage risk

    B. Braun Medical is recalling dispensing pins with an elevated leakage risk in the air inlet filter. The leakage may reduce medication doses, delay treatment, or contaminate the fluid path, potentially causing bloodstream infection.

    Product
    Dispensing Pins for Air Inlet Filter, Product Catalog No. 412005, DP2500 Dispensing Pin W/Valve. A valve for aspiration or injection of medication or enteral feeding solution from inverted multi-dose vials.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0659-2022·2022-03-09

    COVID-19 Rapid Test Kits Recalled for Risk of False Positive Results

    Celltrion DiaTrust COVID-19 Ag Rapid Test kits from lot COVGCCM0008 are being recalled due to reports of false positive results. The affected 243 kits were distributed to six states before the recall.

    Product
    Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-0663-2022·2022-03-09

    Philips Respironics V60 Plus Ventilators with Defective Adhesive Recalled

    Respironics California is recalling 294 V60 Plus ventilators assembled with expired adhesive. The adhesive may fail, causing the bracket to loosen and damage capacitors, potentially stopping ventilation delivery.

    Product
    Philips Respironics V60 Plus Ventilator Part Number 1138747
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-0662-2022·2022-03-09

    Philips V60 Ventilator Recall: Expired Adhesive May Cause Device Failure

    A limited number of Philips Respironics V60 ventilators were assembled with expired adhesive. If the adhesive fails, the ventilator could stop providing ventilation.

    Product
    Philips Respironics V60 Ventilator Part Number 1053617
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-0680-2022·2022-03-09

    Celltrion DiaTrust COVID-19 Rapid Test Kits Recalled for Unauthorized Clinical Use

    Celltrion USA recalled COVID-19 rapid test kits (DiaTrust) in a Class I action. The kits are labeled for research use only, but the firm assured distributors they could be used for clinical diagnosis, which is not authorized.

    Product
    Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0682-2022·2022-03-09

    Titanium Toe Implant Recalled for Incorrect MR Compatibility Claims

    BioPro Titanium MPJ toe implants are being recalled due to incorrect statements in device labeling claiming MR Conditional status when MR testing was not performed on the titanium version.

    Product
    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0655-2022·2022-03-09

    Digital Angiography System generator may exceed safe radiation dose rates

    Shimadzu recalled 28 Digital Angiography Systems with Generator Model D150GC-40 due to inadequate installation adjustment criteria that may cause x-ray radiation dose rates to exceed safe fluoroscopic imaging limits.

    Product
    Digital Angiography System Shimadzu Trinias Generator Model: D150GC-40
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-0712-2022·2022-03-09

    KWIK-STIK Quality Control Kit Recalled for Incorrect Antibiotic Susceptibility

    Microbiologics Inc is recalling KWIK-STIK quality control kits containing Enterococcus faecalis because certain lots are susceptible to Gentamicin Synergy when they should be resistant. The defect could affect laboratory testing accuracy.

    Product
    KWIK-STIK, Quality control kit for culture media, sold as: a. KWIK-STIK 2-pack Enterococcus faecalis derived from ATCC 51299 b. KWIK-STIK 6-pack Enterococcus faecalis derived from ATCC 51299
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0708-2022·2022-03-09

    OPAQUE Lacrimal Plugs recalled due to sterile pouch seal defect

    Lacrimedics is recalling approximately 5,767 units of OPAQUE Lacrimal Plugs due to potential defects in the sterile pouch seal that could compromise product sterility. The affected devices were distributed nationwide and internationally.

    Product
    OPAQUE Herrick Lacrimal Plugs, HP3, 0.3 mm, HP5, 0.5mm, HP7, 0.7.mm, STERILE, EO, Rx only, CE Dry eye treatment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0705-2022·2022-03-09

    K2M Everest MI XT Inner Dilator Recalled for Manufacturing Fit Defect

    K2M recalled 686 units of the Everest MI XT Inner Dilator due to a manufacturing nonconformance preventing proper fit with outer dilators during surgery. Two complaints prompted the recall.

    Product
    Everest MI XT Inner Dilator, Catalog Number 5101-90167
    Category
    Medical Device
    Distribution
    Distributed nationwide