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

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10926–10950 of 27470

  • 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-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-2530-2021·2021-09-29

    Foley Catheter Tray Recalled for Packaging Defects Affecting Sterile Barrier

    C.R. Bard Inc is recalling SureStep Foley Catheter Trays due to potential packaging defects that may compromise the sterile barrier. The affected lot includes 1140 units distributed nationwide.

    Product
    Catalog A800360, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
    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-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-2524-2021·2021-09-29

    C.R. Bard Foley Catheter Kit Recall: Packaging Sterility Defect

    C.R. Bard is recalling Foley catheter kits due to packaging defects that may compromise the sterile barrier. No illnesses have been reported.

    Product
    Catalog A300318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2515-2021·2021-09-29

    Univation X System Knee Implant Devices Recalled for Loosening Risk

    Aesculap Implant Systems is recalling Univation X System knee implant devices because they may loosen, potentially requiring revision surgery. All lots distributed in the US are affected.

    Product
    Univation X System knee implant devices as follows: Catalog/Product: NO180Z AS UNIVATION XF FEMUR CEMENTED F1 RM; NO181Z AS UNIVATION XF FEMUR CEMENTED F2 RM; NO182Z AS UNIVATION XF FEMUR CEMENTED F3 RM; NO183Z AS UNIVATION XF FEMUR CEMENTED F4 RM; NO184Z AS UNIVATION
    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-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-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-2507-2021·2021-09-29

    Greiner VACUETTE 2 ml Coagulation Blood Collection Tubes Anticoagulant and Vacuum Recall

    Greiner Bio-One is recalling 956,400 VACUETTE coagulation blood collection tubes that may clot due to anticoagulant variation or low vacuum.

    Product
    Greiner Bio-One VACUETTE¿ TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2525-2021·2021-09-29

    C.R. Bard Foley Catheter Tray Recalled for Potential Packaging Defect

    C.R. Bard is recalling 11,600 units of its Foley catheter tray assembly nationwide due to potential packaging defects that may compromise the sterile barrier.

    Product
    Catalog A303316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2490-2021·2021-09-29

    Biopsy Needle Recall Due to Compromised Sterility Assurance

    M.D.L. S.r.l. is recalling 2,750 Aspirated Cyto-Histological Biopsy needles nationwide due to compromised sterility assurance. Affected healthcare providers and patients should consult their healthcare provider for guidance.

    Product
    Aspirated Cyto-Histological Biopsy needle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2516-2021·2021-09-29

    Univation X System Tray knee implants recalled for loosening defect

    Aesculap is recalling Univation X System Tray knee implants due to a loosening defect that may require revision surgery. All lots nationwide are affected.

    Product
    Univation X System Tray Sysem knee implant devices as follows: Tray Number/Set Name/Set Number NM1090R Navigation Set ST0560; NM1092R + NM1095R + NM1096R (Tray insert to NM1095R) univation XF ST0540; NM1093R univation XF OPT ST0544
    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-2506-2021·2021-09-29

    CoLink Bone Graft Harvester Recalled for Breaking at Weld Site

    In2bones USA is recalling CoLink Bone Graft Harvesters after reports of the instruments breaking at the outer tube weld site. The recall affects 835 units distributed nationwide across 29 states.

    Product
    CoLink Bone Graft Harvester, 8mm, Sterile, Disposable, REF G05 S1008 - Product Usage: is a general instrument intended for assisting surgeons in the manipulation of bone during surgical procedures.
    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-2488-2021·2021-09-29

    Phantom Nail System surgical drill recalled for fracture risk

    Paragon 28 is recalling Phantom Nail System surgical drills due to a thin wall condition between the cannulation and flutes. This defect could potentially cause the drill to fracture during use.

    Product
    Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 P99-110-4630
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2512-2021·2021-09-29

    Univation X Knee Implant Devices Recalled Due to Loosening Risk

    Aesculap Implant Systems is recalling Univation X System knee implant devices (all lots, nationwide) because the implants may loosen, potentially requiring revision surgery. No injuries have been reported.

    Product
    Univation X System knee implant devices as follows: Catalog/Product: NL488 UNIVATION F MENISCAL COMP.T1 RM/LM 10MM; NL489 UNIVATION F MENISCAL COMP.T2 RM/LM 10MM; NL490 UNIVATION F MENISCAL COMP.T3 RM/LM 10MM; NL491 UNIVATION F MENISCAL COMP.T4 RM/LM 10MM; NL492 UNIVATION
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2529-2021·2021-09-29

    Foley Catheter Tray Recalled Due to Potential Packaging Defects

    C.R. Bard is recalling 2,660 units of SureStep Foley Catheter Trays nationwide due to potential packaging defects that may impact the sterile barrier.

    Product
    Catalog A800061, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
    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-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-2537-2021·2021-09-29

    C.R. Bard Foley Catheter Tray Recall Due to Packaging Defects

    C.R. Bard Inc is recalling the SureStep Foley Tray (Lot NGEVX108) due to potential packaging defects that may affect the sterile barrier. The product was distributed nationwide.

    Product
    Catalog A943216, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2502-2021·2021-09-29

    Centricity PACS Medical Imaging System Image Acquisition and Synchronization Failures

    GE Healthcare's Centricity PACS-IW system experiences image acquisition and synchronization failures that could impair the display of medical images. The software malfunction affects 392 devices globally.

    Product
    Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that displays medical images (including mammograms) and data from various imaging sources.
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2498-2021·2021-09-29

    cobas SARS-CoV-2 and Influenza A/B Test Recalled Due to False Positive Results

    Roche Molecular Systems is recalling cobas SARS-CoV-2 & Influenza A/B test kits following reports of increased false positive SARS-CoV-2 results.

    Product
    cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190
    Category
    Medical Device
    Distribution
    Distributed nationwide