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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11926–11950 of 13837

  • 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-0970-2022·2022-04-27

    Siemens Artis zee biplane X-ray system cooling defect recall

    Siemens is recalling 373 Artis zee biplane X-ray diagnostic systems due to a cooling circuit defect that could prevent adequate tube cooling. When the coolant level drops, the system may overheat and shut down imaging capabilities.

    Product
    Artis zee biplane, Model Number 10094141
    Category
    Medical Device
    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
  • 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 (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-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-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-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-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-0983-2022·2022-04-27

    GE Healthcare MRI Systems May Fall During De-Installation Without Proper Rigging

    GE Healthcare MRI systems may fall during magnet de-installation if rigging and hardware are not properly installed and secured, creating a potential injury hazard.

    Product
    GE Healthcare MR Systems, Magnetic Resonance imaging (MRI). SIGNA Premier, SIGNA Architect, SIGNA Pioneer, Discovery MR750w 3.0T, Discovery MR750 3.0T, SIGNA PET/MR, 1.5T SIGNA Creator, 1.5T SIGNA Explorer, 1.5T SIGNA MR355, 1.5T SIGNA MR360, 1.49T SIGNA MR380, SIGNA Voyager,
    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-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-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-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-0946-2022·2022-04-27

    Virus Counter Platform VC3100 Class II Medical Device Recall

    Sartorius Corporation is recalling the Virus Counter Platform Model VC3100 (model numbers VIR-92166, VIR-92341) distributed nationwide to 82 units, classified as a Class II FDA medical device recall.

    Product
    Virus Counter Platform with Model Name VC3100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0951-2022·2022-04-27

    Genetic Testing Kit Recalled for Inaccurate Mutation Test Results

    Qiagen Sciences' KRAS mutation testing kit can produce false positive or false negative results due to testing flags or warnings. 435 kits distributed across 16 U.S. states are affected.

    Product
    therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)
    Category
    Medical Device
    Distribution
    17 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-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-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
  • 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