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.

Filters

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

Category

All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

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

Clear filters

12951–12975 of 13802

  • HighFDA (Devices)·Z-2500-2021·2021-09-29

    Siemens CT Scanners: Software Errors May Interrupt Scanning Workflows

    Siemens SOMATOM CT systems with certain software versions may experience sporadic errors causing workflow interruptions and diagnostic delays. Affected systems should be updated to prevent scan aborts and patient rescans.

    Product
    Computed tomography x-ray systems with software syngo.CT VA20A_SP4a, VA20A_SP5, VA30A_SP2, VA30A_SP2a, VA30A_SP3,VA30A_FP2 in Somatom systems: SOMATOM go.Up - Model 11061620 SOMATOM go.Up - Model 11061628 SOMATOM go.All - Model 11061630 SOMATOM go.Top - Model 11061640 SOMATO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2483-2021·2021-09-29

    Philips EPIQ Ultrasound Systems Recalled for Software Lock-up Defect

    Philips Ultrasound Inc is recalling EPIQ Diagnostic Ultrasound Systems due to a software defect that can cause the device to lock-up while exiting Review Mode during patient exams. Approximately 10,583 systems worldwide are affected.

    Product
    EPIQ Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: EPIQ 5 - 795120 EPIQ 5C - 795205 EPIQ 5G - 795204 EPIQ 7 - 795117 EPIQ 7C - 795201 EPIQ 7G - 795200 EPIQ CVxi -795232 EPIQ CVx - 795231
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2539-2021·2021-09-29

    SureStep Foley Catheter Tray Recalled for Sterile Barrier Packaging Defect

    C.R. Bard Inc is recalling approximately 4830 SureStep Foley catheter trays due to potential packaging defects that could compromise the sterile barrier.

    Product
    Catalog A902416, SureStep" Foley Tray, Silicone, Urine Meter, StatLock" Stabilization Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2526-2021·2021-09-29

    C.R. Bard Foley Catheter Trays Recalled for Packaging Defects

    C.R. Bard is recalling 420 units of Foley catheter care trays nationwide due to potential packaging defects that may impact the sterile barrier.

    Product
    Catalog A303318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2517-2021·2021-09-29

    Sight OLO-E1/U1 Reference Range Labeling Discrepancy in Software

    The Sight OLO-E1/U1 diagnostic device software contains a labeling discrepancy: the operator's manual and software present different adult CBC reference ranges, potentially affecting the interpretation of diagnostic results.

    Product
    Sight OLO-E1/U1 Software and Operators Manual Software v2.56.1 Catalog #: 1 OLO-U1 Catalog #: 2 OLO-E1 revision 1.9, revision 1.10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2535-2021·2021-09-29

    SureStep Foley Tray Recall: Packaging Defects May Compromise Sterile Barrier

    C.R. Bard Inc is recalling SureStep Foley Trays (Catalog A902616) due to packaging defects that may compromise the sterile barrier. Affected units were distributed nationwide.

    Product
    Catalog A902616, SureStep" Foley Tray, Bardex" I.C., Lubricath", Urine Meter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2510-2021·2021-09-29

    Aesculap Univation X System knee implant devices recalled for potential loosening

    Aesculap is recalling Univation X System knee implants nationwide because they may loosen, potentially requiring revision surgery.

    Product
    Univation X System knee implant devices as follows: Catalog/Product: NL476 UNIVATION F MENISCAL COMP.T1 RM/LM 8MM; NL477 UNIVATION F MENISCAL COMP.T2 RM/LM 8MM; NL478 UNIVATION F MENISCAL COMP.T3 RM/LM 8MM; NL479 UNIVATION F MENISCAL COMP.T4 RM/LM 8MM; NL480 UNIVATION F ME
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2501-2021·2021-09-29

    Scorpion Portal Vein Access Set Recalled for Cracking Sheaths

    Argon Medical Devices is recalling the Scorpion Portal Vein Access Set due to design changes that have caused the sheaths to crack or break at the tips. The affected product was distributed in the United States.

    Product
    Scorpion Portal Vein Access Set - Product Usage: used to gain access to the hepatic vein and guide a sharp puncture tool (0.040 Stylet or 17ga Needle) through the parenchyma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2528-2021·2021-09-29

    C.R. Bard Foley Catheter Trays Recalled for Sterile Packaging Defects

    C.R. Bard is recalling 3,980 units of Foley catheter supply kits due to potential packaging defects that may compromise the sterile barrier. No illnesses have been reported.

    Product
    Catalog A399400A, SureStep" Foley Tray, Add-a-Foley, Complete Care", Drainage Bag, StatLock" Stabilization Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2534-2021·2021-09-29

    C.R. Bard Foley Catheter Kits Recalled for Potential Sterile Barrier Defects

    C.R. Bard is recalling 960 units of Foley Tray catheter kits (lot NGFR0101) due to potential packaging defects that may compromise the sterile barrier.

    Product
    Catalog A899916, SureStep" Foley Tray, Lubricath", Drainage Bag, StatLock" Stabilization Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2521-2021·2021-09-29

    C.R. Bard SureStep Foley Tray Recalled for Packaging Defect Risk

    C.R. Bard is recalling SureStep Foley Tray units due to potential packaging defects that may compromise the sterile barrier. The recalled product was distributed nationwide in the United States.

    Product
    Catalog A119216M, SureStep" Foley Tray, Lubri-Sil", Urine Meter, Temperature Sensing Dual, StatLock" Stabilization Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2532-2021·2021-09-29

    SureStep Foley Catheter Tray Recalled for Packaging Defects

    C.R. Bard is recalling 18,060 units of SureStep Foley Catheter Trays due to potential packaging defects that may compromise the sterile barrier. No illnesses or injuries have been reported.

    Product
    Catalog A800365, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2522-2021·2021-09-29

    Foley Catheter Drainage Tray System Packaging Defect Recall

    C.R. Bard Inc is recalling a Foley catheter tray system due to potential packaging defects that may compromise the sterile barrier, affecting 1,760 units distributed nationwide.

    Product
    Catalog A300314A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2504-2021·2021-09-29

    DLP Left Heart Vent Catheters recalled due to potential wire protrusion

    Medtronic is recalling 51,494 DLP Left Heart Vent Catheters due to potential wire protrusion through the catheter tip. This defect could compromise proper device function during use.

    Product
    DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2493-2021·2021-09-29

    General Manual Surgical Instruments Recalled Due to Compromised Sterility Assurance

    M.D.L. S.r.l. is recalling approximately 4,120 units of general manual surgical instruments nationwide due to compromised sterility assurance. Healthcare facilities should verify lot numbers and quarantine affected instruments immediately.

    Product
    General Manual surgical instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2538-2021·2021-09-29

    C.R. Bard Foley Catheter Tray Recalled for Packaging Defects

    C.R. Bard is recalling a Foley catheter tray system due to packaging defects that may compromise the sterile barrier. The recall affects 8,170 units distributed nationwide.

    Product
    Catalog A319516AM, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing Complete Care", Drainage Bag, StatLock" Stabilization Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2494-2021·2021-09-29

    Ad-Tech Medical Cable Recalled Due to Incorrect Product Labels

    Ad-Tech Lightweight CABRIO Cables with incorrect labels are being recalled. Mislabeling could cause product misidentification affecting proper use in clinical monitoring applications.

    Product
    Ad-Tech Lightweight CABRIO Cable - Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimulators.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2489-2021·2021-09-29

    Bone Marrow Biopsy Needles Recalled for Sterility Assurance Concerns

    M.D.L. S.r.l. is recalling approximately 21,518 bone marrow biopsy needles distributed nationwide because sterility assurance may be compromised.

    Product
    Bone Marrow Transplantation biopsy needle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2505-2021·2021-09-29

    DLP Left Heart Vent Catheters Recalled for Potential Wire Protrusion

    Medtronic recalls DLP Left Heart Vent Catheters due to risk of wire protrusion through the catheter tip. The defect could cause internal injury during cardiac procedures.

    Product
    DLP Left Heart Vent Catheters, 18 FR. Sterile, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2527-2021·2021-09-29

    C.R. Bard SureStep Foley Catheter Tray Sterile Barrier Defect Recall

    C.R. Bard is recalling 5,950 SureStep Foley Tray kits nationwide due to potential packaging defects that may impact the sterile barrier.

    Product
    Catalog A319416AM, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, Temperature Sensing, StatLock" Stabilization Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2497-2021·2021-09-29

    Bronchofibervideoscope recalled for potential leak in insertion tube

    Olympus is recalling the EVIS EXERA BF-XT160 bronchofibervideoscope due to a missing gluing step in manufacturing. The affected devices may develop leaks in the insertion tube, posing an infection control risk.

    Product
    EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2503-2021·2021-09-29

    GE Healthcare Medical Imaging Software Recall: Image Acquisition and Archive Synchronization Failures

    GE Healthcare is recalling Centricity Universal Viewer and Viewer 6.0 software due to image acquisition and synchronization failures with the Centricity Enterprise Archive that could impact diagnostic data integrity.

    Product
    Centricity Universal Viewer and Viewer 6.0 - Product Usage: Is a device that displays medical images (including mammograms) and data from various imaging sources. Includes the following Model Numbers: 1. Model Number: 2090255-001; 2. Model Number: 2088026-723; 3. Model Nu
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2523-2021·2021-09-29

    C.R. Bard Foley Tray and Drainage Bag Recalled for Packaging Defects

    C.R. Bard is recalling 11,780 Foley Tray units nationwide due to potential packaging defects that may compromise the sterile barrier.

    Product
    Catalog A300316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2541-2021·2021-09-29

    C.R. Bard Foley Tray Recalled for Potential Sterile Barrier Packaging Defects

    C.R. Bard Inc is recalling Foley Tray kits nationwide due to potential packaging defects that may compromise the sterile barrier. The product was distributed throughout the United States.

    Product
    Catalog A942216, SureStep" Foley Tray, Bard LubricathTM, Urine Meter, StatLock" Stabilization Device
    Category
    Medical Device
    Distribution
    Distributed nationwide