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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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

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Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

11826–11850 of 13717

  • HighFDA (Devices)·Z-0986-2022·2022-04-27

    Diagnostic imaging system software malfunction may interrupt clinical procedures

    Siemens is recalling 35 Artis icono floor diagnostic imaging systems due to five potential software errors affecting equipment movements and detector control. The defects may limit functionality during procedures and could delay clinical treatment until the system is restarted.

    Product
    Artis icono floor in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0976-2022·2022-04-27

    Artis Q biplane X-ray systems cooling failure may prevent adequate tube cooling

    Siemens is recalling 269 Artis Q biplane X-ray systems due to potential coolant level drops that may prevent the X-ray tube from cooling adequately, triggering automatic system shutdown.

    Product
    Artis Q biplane, Model Number 10848282
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0962-2022·2022-04-27

    CT Scanner Software Error May Cause Scanning Interruptions and Unexpected Radiation

    Siemens SOMATOM CT scanners with software syngo CT VA30A_SP4 may experience sporadic software errors causing scanning interruptions and potential unexpected radiation doses. 547 units affected nationwide.

    Product
    SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0963-2022·2022-04-27

    Sight OLO Blood Analysis Device: Incorrect Reference Ranges May Display

    The Sight OLO blood analysis device may display and print incorrect reference ranges in software versions 2.59.3 and earlier. This could occur when custom reference ranges were configured after device installation.

    Product
    The Sight OLO device is a computer vision based platform for blood analysis. The platform combines computer-vision algorithms for image processing to identify and quantify blood components (e.g., red blood cells) and their characteristics (e.g., cell volume) in an automated fa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0978-2022·2022-04-27

    Medical device X-ray imaging system recalled for cooling failure

    Siemens Medical Solutions is recalling its Artis Q.zen X-ray imaging system due to a coolant circulation defect that may cause insufficient tube cooling and system shutdown.

    Product
    Artis Q.zen floor, Model Number 10848353
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0950-2022·2022-04-27

    FDA recalls Regard IV Start Kit component over safety issue

    Resource Optimization & Innovation LLC is recalling 3,570 Regard IV Start Kits due to a recalled component, the PDI Prevantics Swab. The affected kits were distributed to two consignees in Missouri.

    Product
    Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0969-2022·2022-04-27

    Medical X-ray imaging system recalled for cooling circuit malfunction

    Siemens' Artis zee X-ray imaging systems may have inadequate cooling if the coolant level drops, potentially causing X-ray tube overheating. The system displays warnings and blocks X-ray operation to prevent equipment damage.

    Product
    Artis zee multi-purpose, Model Number 10094139
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0973-2022·2022-04-27

    Artis zeego X-ray imaging system recalled for insufficient cooling

    Siemens is recalling 183 Artis zeego X-ray imaging systems due to a cooling system defect that may prevent adequate X-ray tube cooling, triggering automatic system shutdown.

    Product
    Artis zeego, Model Number 10280959
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0975-2022·2022-04-27

    X-ray Imaging System Coolant Deficiency May Disable Equipment Operation

    The Artis Q X-ray system may fail to adequately cool the X-ray tube if coolant levels drop, causing the system to disable imaging and display error messages. 418 systems are affected nationwide.

    Product
    Artis Q ceiling, Model Number 10848281
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0945-2022·2022-04-27

    Acon Biotech Flowflex COVID-19 Rapid Test Recalled for Inaccurate Results

    Acon Biotech is recalling Flowflex SARS-CoV-2 Antigen Rapid Tests because the non-EUA authorized kits may produce inaccurate results, including false negatives or false positives.

    Product
    Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0988-2022·2022-04-27

    Gallant DR Implantable Cardioverter Defibrillator Bluetooth Malfunction Affects Remote Monitoring

    St. Jude Medical's Gallant DR implantable cardioverter defibrillator has a Bluetooth malfunction preventing remote monitoring and reducing battery life. The device enters inductive-only telemetry mode, requiring in-clinic monitoring instead.

    Product
    Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0974-2022·2022-04-27

    Artis Q floor X-ray system cooling failure poses overheating risk

    Siemens is recalling 80 Artis Q floor X-ray systems nationwide due to a cooling circuit failure that may cause insufficient cooling of the X-ray tube, resulting in automatic system shutdown.

    Product
    Artis Q floor, Model Number 10848280
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0985-2022·2022-04-27

    Medical imaging system software errors may delay treatment procedures

    Siemens Artis icono biplane diagnostic imaging systems may experience software errors affecting block movements and detector rotation, potentially delaying treatment until the system is restarted.

    Product
    Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327600
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0955-2022·2022-04-27

    Inactivated Mycoplasma genitalium reference material recalled due to inadequate QC

    Microbiologics Inc is recalling an inactivated Mycoplasma genitalium reference material (Catalog # HE0070N, Lot HE0070-01-1) because the quality control process did not meet specification requirements.

    Product
    Inactivated macrolide-resistant Mycoplasma genitalium
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0954-2022·2022-04-27

    Medical Device Reference Standard Recalled for Inadequate Quality Control Process

    Microbiologics Inc recalls an inactivated Mycoplasma genitalium reference standard (Lot HE0069-02-1) because its quality control process did not meet specification requirements. This reference material is used in diagnostic and laboratory testing.

    Product
    Inactivated macrolide and quinolone-resistant Mycoplasma genitalium
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0948-2022·2022-04-27

    Baxter Syringe Tip Caps Recalled Due to Incorrect Labeling

    Baxter is recalling DISCPAC syringe tip caps that are mislabeled as self-righting when they do not possess this capability, risking improper use in medical procedures.

    Product
    Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow, REF H93866100, 100 slip tip caps/package.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0956-2022·2022-04-27

    Abbott TactiCath Ablation Catheter Disabled by Preprogrammed First-Use Date

    Abbott is recalling 2,134 TactiCath ablation catheters manufactured with a preprogrammed 'First Use Date' that disables the device. Affected devices with 37 specific lot numbers were distributed in the U.S. and 21 other countries.

    Product
    Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F, Model A-TCSE-DF, Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0984-2022·2022-04-27

    Beckman Coulter IRISpec CA Control glucose measurement failures recalled

    Beckman Coulter is recalling IRISpec CA/CB/CC control kits due to failures in glucose measurement for the CA Control component. The recall affects laboratory quality control products distributed worldwide.

    Product
    Beckman Coulter IRISpec CA/CB/CC control, Catalog #800-7211, containing 3 x 100 mL bottles each of CA Control, CB Control, and CC Control.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0968-2022·2022-04-27

    X-ray Imaging System Cooling Failure May Cause Tube Overheating

    Siemens Artis zee ceiling X-ray systems may fail to cool the X-ray tube if the coolant level drops. The system will automatically block X-ray emissions and display warning messages to prevent equipment damage.

    Product
    Artis zee ceiling, Model Number 10094137
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0981-2022·2022-04-27

    Oral DNA Collection Device Recalled for Evaporating Stabilizing Liquid

    DNA Genotek Inc. is recalling ORAcollect Dx oral DNA collection devices because the stabilizing liquid can evaporate, reducing shelf life and potentially affecting sample preservation.

    Product
    ORAcollect Dx, Catalog Number/SKU: OCD-100, OCD-100A. Material numbers: OCD-100, OCD-100.008, OCD-100.012, OCD-100.014+ACP078, OCD-100.014+ACP078, OCD-100.032 and OCD-100A, OCD-100A.022, OCD-100A.023, OCD-100A.024, OCD-100A.025
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0971-2022·2022-04-27

    X-Ray Imaging System Cooling Circuit Failure Recall

    Siemens is recalling Artis zee floor MN X-ray systems due to a potential cooling circuit malfunction. If coolant drops below adequate levels, the X-ray tube may not cool properly and the system will automatically shut down.

    Product
    Artis zee floor MN, Model Number 10094142
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0982-2022·2022-04-27

    Oral RNA Collection Kit Recalled Due to Stabilizer Evaporation

    DNA Genotek Inc. is recalling ORAcollect RNA: ORE-100 kits due to evaporation of the stabilizing liquid, which reduces shelf life. Approximately 17,080 units are affected, including lot YJ530.

    Product
    ORAcollect RNA: ORE-100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0980-2022·2022-04-27

    Artis Q.zen Biplane X-ray Systems Coolant Level Failure Recall

    Siemens is recalling 69 Artis Q.zen biplane systems where coolant levels may drop sufficiently to prevent adequate X-ray tube cooling, triggering automatic shutdown safeguards.

    Product
    Artis Q.zen biplane, Model Number 10848355
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0949-2022·2022-04-27

    Terumo Cardiovascular Procedure Kit Recall for Shipping Damage

    Terumo Cardiovascular Systems Corp is recalling two lots of cardiovascular procedure kits due to packaging damage that occurred during shipping. The recall affects 64 units distributed in California and Indiana.

    Product
    Cardiovascular Procedure Kit catalog # 76645 & 73806
    Category
    Medical Device
    Distribution
    Distributed nationwide