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 the agency’s own highest classification or reported deaths or serious injuries, 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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25851–25875 of 90145

  • 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-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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·22V279000·2022-04-27

    Blue Bird Recalls 2023 Vision School Buses for Stop Arm Defect

    Blue Bird is recalling 2023 Vision school buses because incorrect pins on the air stop arm may cause it to fail, increasing injury risk during boarding.

    Product
    BLUE BIRD — BLUE BIRD VISION SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0952-2022·2022-04-27

    Qiagen therascreen KRAS RGQ PCR Kit Recall: False Positive/Negative Results

    Qiagen Sciences LLC is recalling the therascreen KRAS RGQ PCR Kit due to potential false positive or false negative results in KRAS G12C mutation detection. These inaccurate results could invalidate clinical test outcomes.

    Product
    therascreen KRAS RGQ PCR Kit (24) REF 874052 (Japan IVD, not released in the USA)
    Category
    Medical Device
    Distribution
    17 states
  • 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
  • HighNHTSA·22V281000·2022-04-27

    Daimler Recalls 2019-2021 Sprinter Vehicles for Rearview Camera Software Error

    Daimler Vans USA is recalling 2019-2021 Freightliner and Mercedes-Benz Sprinter vans because a software error may prevent the rearview camera from displaying an image.

    Product
    FREIGHTLINER — FREIGHTLINER, MERCEDES-BENZ SPRINTER 4500, SPRINTER 1500, SPRINTER 2500, SPRINTER 3500
    Category
    Vehicle
    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
  • HighFDA (Drugs)·D-0778-2022·2022-04-27

    Injectable Drug Recalled Due to Sterility Assurance Concerns

    North American Custom Laboratories is recalling LL-37 2 mg/mL injectable vials due to manufacturing process deviations that raise questions about product sterility. The company distributed 25 vials nationwide.

    Product
    LL-37 2 mg/mL (5 mL) Injection, 5 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA
    Category
    Drug
    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-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-0987-2022·2022-04-27

    Siemens Artis pheno diagnostic imaging system software malfunction recall

    Siemens Medical Solutions is recalling 20 Artis pheno diagnostic imaging systems nationwide due to software errors in block movement and detector rotation functions. The malfunction may limit device functionality and delay clinical treatment until the system restarts.

    Product
    Artis pheno- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use-single and biplane diagnostic imaging and interventional procedures. Model: 10849000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0957-2022·2022-04-27

    Abbott TactiCath Ablation Catheters Recalled for Software-Disabled Devices

    Abbott has recalled 588 TactiCath ablation catheters that were preprogrammed with a 'First Use Date' disabling device functionality. The catheters were distributed worldwide and throughout the U.S.

    Product
    Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve DD, Model A-TCSE-DD, Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0779-2022·2022-04-27

    Melanotan II Injectable Recalled for Manufacturing Sterility Defect

    Melanotan II injection (35 vials) is being recalled nationwide due to manufacturing deviations that could compromise product sterility. Patients should not use affected lots and should contact their healthcare provider.

    Product
    Melanotan II 1 mg/mL (10 mL) Injection, 10mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0977-2022·2022-04-27

    Artis Q zeego X-ray system recalled for inadequate cooling risk

    Siemens is recalling 38 Artis Q zeego X-ray systems nationwide due to a cooling circuit malfunction that may prevent adequate cooling of the X-ray tube, triggering automatic system shutdown.

    Product
    Artis Q zeego, Model Number 10848283
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0959-2022·2022-04-27

    Acumed Cannulated Screws Recalled for Insufficient Axial Pullout Strength

    Acumed LLC is recalling Cannulated Screws (4.0mm x 12mm) that may not have sufficient strength to hold bone fragments together, risking fracture or joint damage.

    Product
    4.0mm x 12mm Cannulated Screw, Short Thread; Part number 3005-40012
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-0967-2022·2022-04-27

    Artis zee floor X-ray systems recalled for cooling system failure

    Siemens is recalling 305 Artis zee floor X-ray imaging systems because the cooling circuit may fail to maintain adequate coolant levels, potentially causing the X-ray tube to overheat. The system includes automatic safeguards that shut down X-ray operation if overheating is detected.

    Product
    Artis zee floor, Model Number 10094135
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0775-2022·2022-04-27

    Injectable Drug Recall: ARA-290 Due to Sterility Manufacturing Defects

    ARA-290 (Cibinetide Acetate) injection is recalled due to manufacturing deviations that call sterility into question. Patients should contact their healthcare provider, as 28 vials have been distributed nationwide.

    Product
    ARA-290 (Cibinetide Acetate) 6 mg/mL (4 mL) Injection, 4 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0780-2022·2022-04-27

    PT-141 Injection Recalled for Sterility Assurance Defect

    PT-141 (Bremelanotide) injection vials are recalled due to manufacturing deviations that compromise sterility assurance. The FDA Class II recall involves 43 vials distributed nationwide.

    Product
    PT-141 (Bremelanotide Acetate) 10 mg/mL (2 mL) Injection, 2mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081
    Category
    Drug
    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-0960-2022·2022-04-27

    HUNTLEIGH Disposable Intraoperative Probe recalled for detachable faceplate

    Huntleigh Healthcare Ltd. is recalling 150 HUNTLEIGH Disposable Intraoperative Probes (8MHz) because the faceplate may become detached from the probe body during use.

    Product
    HUNTLEIGH Disposable intraoperative Probe, 8Mhz (box), REF DIPP10, containing 10 individual Disposable Intraoperative Probes, REF DIOP8
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0777-2022·2022-04-27

    Ipamorelin and Sermorelin Injectable Medications Recalled Due to Sterility Deviations

    North American Custom Laboratories is recalling 189 vials of Ipamorelin/Sermorelin injectable due to manufacturing deviations that call into question the sterility of this prescription medication.

    Product
    Ipamorelin Acetate/Sermorelin Acetate (1 mg/1 mg)/mL (10 mL) Injection, 10 mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0961-2022·2022-04-27

    Medical device software defect causes incorrect rotation count in surgical handpiece

    Medtronic Xomed integrated power console software version 2.7.3.0 has a defect that causes the set number of rotations to mismatch the actual rotations in specific modes when used with M5 handpieces. No injuries have been reported.

    Product
    Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOLE IPC REFURB, Product Number EC300RF; c) MASTER CONSOLE EC300 LEGEND EHS, Product Number EC300
    Category
    Medical Device
    Distribution
    0 states