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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All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

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

Clear filters

11901–11925 of 13816

  • SevereFDA (Devices)·Z-0907-2022·2022-04-27

    Philips Respironics V60 Ventilator Recalled Due to Electrical Circuit Defect

    Philips Respironics V60 ventilators are recalled due to an internal electrical circuit defect that may cause the device to stop operating. Approximately 87,138 units worldwide are affected.

    Product
    Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, 1053615, 1053616, 1053617, 1053618, 1076709, 1076716, 1076717, 1137292, DU1053617, U1053617, R1053618, R1076709)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0927-2022·2022-04-27

    Medtronic Harmony Delivery Catheter System Recalled Over Equipment Failure Risk

    Medtronic is recalling 1,483 Harmony Delivery Catheter Systems due to potential capsule bond failure during pulmonary valve replacement procedures. The FDA has classified this as a Class I recall affecting devices distributed in the US and Canada.

    Product
    Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0909-2022·2022-04-27

    Philips Respironics V680 Ventilator May Stop Operating Due to Electrical Fault

    Philips Respironics V680 Ventilators may stop operating due to an internal electrical circuit fault. Units were distributed worldwide and across the United States.

    Product
    Philips Respironics V680 Ventilator (All Models, including: P/N 1103044 (850011)), *Distributed outside the United States
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0908-2022·2022-04-27

    Philips Respironics V60 Plus Ventilator Recalled for Electrical Circuit Failure Risk

    Philips Respironics V60 Plus Ventilators are recalled for an internal electrical circuit defect that could cause the device to stop operating. Approximately 12,145 units were affected worldwide.

    Product
    Philips Respironics V60 Plus Ventilator (All Models, including: 1138747, 1137276)
    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-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 (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-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-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 (Devices)·Z-0979-2022·2022-04-27

    Siemens Artis Q.zen ceiling system recall: inadequate X-ray tube cooling risk

    Siemens recalls 81 Artis Q.zen ceiling imaging systems distributed nationwide due to risk of inadequate X-ray tube cooling if coolant levels fall below a critical threshold, potentially triggering system shutdown.

    Product
    Artis Q.zen ceiling, Model Number 10848354
    Category
    Medical Device
    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-0964-2022·2022-04-27

    Merlin PCS 3650 Programmer May Fail to Terminate Pacing Test Properly

    A software anomaly in the Merlin PCS 3650 programmer may cause an in-clinic pacing test to fail terminating and prevent restoration of the implanted device's normal settings. Approximately 30,069 affected devices have been distributed worldwide.

    Product
    Merlin PCS 3650 programmer Model 3330 software
    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-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-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-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-0947-2022·2022-04-27

    Matrix COVID-19 Test Kits Recalled for Unauthorized Home Sample Collection

    Matrix Medical Network is recalling 3,226 At-Home COVID-19 Test kits distributed across 24 U.S. states because the tests were not authorized by the FDA for home sample collection.

    Product
    Matrix Clinical Solution At-Home COVID-19 Test
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-0965-2022·2022-04-27

    Cardiac Device Programmer Software May Fail to Terminate Test

    St. Jude Medical's Merlin 2 programmer software can fail to stop a clinical Decrement Test and restore pacing parameters during in-clinic testing, affecting 401 devices worldwide.

    Product
    Merlin 2 PCS MER3700 programmer Model MER3400 software
    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-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-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-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-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 (Devices)·Z-0958-2022·2022-04-27

    Acumed Cannulated Screws May Lack Sufficient Strength for Bone Fixation

    Acumed 4.0mm x 10mm Cannulated Screws may not have sufficient strength to hold bone fragments in place. This could result in improper bone healing, fracture, or soft tissue damage.

    Product
    4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010
    Category
    Medical Device
    Distribution
    Distributed nationwide