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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13001–13025 of 13816

  • 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-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-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-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-2484-2021·2021-09-29

    Philips Affiniti Ultrasound Systems Recalled for Software Lock-Up During Exams

    Philips Ultrasound is recalling Affiniti diagnostic ultrasound systems due to a software defect that intermittently causes device lock-ups when exiting Review Mode during patient exams. No illnesses or injuries have been reported.

    Product
    Affiniti Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: Affiniti 30 795121 Affiniti 30 795218 Affiniti 50 795208 Affiniti 50 795118 Affiniti 70 795210 Affiniti 70 795119
    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-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-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-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-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-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-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
  • ModerateFDA (Devices)·Z-2520-2021·2021-09-29

    Decompression Needle Recall Due to Incorrect Instructions for Use

    North American Rescue is recalling 51,424 units of 10 ga ARS Decompression Needles due to incorrect Instructions for Use. Affected parties should stop using and contact manufacturer.

    Product
    10 ga ARS Decompression Needle, Part Number ZZ-0298
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2486-2021·2021-09-29

    Microbiologics SARS-CoV-2 Process Control Pellets Recalled for Product Specification Issue

    Microbiologics Inc is recalling 218 units of SARS-CoV-2 process control pellets (catalog HE0062S) used to validate diagnostic tests. The FDA Class II recall involves product composition regarding RNA transcript content.

    Product
    SARS-CoV-2 Process Control (Pellet) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance of nucleic acid tests that detect SARS-CoV-2 virus.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2487-2021·2021-09-29

    SARS-CoV-2 Process Control Swab Recalled Due to Plasmid DNA Contamination

    Microbiologics Inc is recalling its SARS-CoV-2 Process Control (Swab) because certain lot numbers were contaminated with plasmid DNA containing SARS-CoV-2 sequences. The affected product was distributed in the United States and internationally.

    Product
    SARS-CoV-2 Process Control (Swab) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance of nucleic acid tests that detect SARS-CoV-2 virus.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2495-2021·2021-09-29

    Ad-Tech TECH ATTACH Cable Recalled for Incorrect Label Information

    Ad-Tech Medical recalled its Lightweight TECH ATTACH Cable due to incorrect labels on affected units. The cables are designed to connect electrodes to third-party monitors and stimulators.

    Product
    Ad-Tech Lightweight TECH ATTACH Cable - Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimulators.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2496-2021·2021-09-29

    Ad-Tech TECH ATTACH Cable Recalled Due to Incorrect Labeling

    Ad-Tech Medical Instrument Corporation is recalling TECH ATTACH Cables due to incorrect labeling. The cables connect electrodes to third-party monitors and stimulators.

    Product
    Ad-Tech TECH ATTACH Cable- Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimulators.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2433-2021·2021-09-22

    AMSORB PLUS Anesthesia Canisters Recalled for Gas Flow Obstruction Risk

    Armstrong Medical Services Limited is recalling AMSORB PLUS PREFILLED anesthesia canisters due to risk of high resistance to gas flow that could prevent adequate ventilation. Not all defective units will be detected by standard pre-use testing.

    Product
    AMSORB PLUS PREFILLED G-CAN 1.0L; Carbon dioxide absorbent canister; Product codes AMAB3801 and AMAB3801GE. Used in anesthesia.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2428-2021·2021-09-22

    Angiographic Catheter Recall: Cordis SUPER TORQUE Entrapment and Dislodgement Risk

    Cordis is recalling its SUPER TORQUE MB Angiographic Catheter worldwide because it may become entrapped between endovascular devices and the vessel wall. This entrapment can cause marker band movement or dislodgement.

    Product
    Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter, REF SRD6785MB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2432-2021·2021-09-22

    Cordis SUPER TORQUE MB Angiographic Catheter Recalled for Device Entrapment Risk

    Cordis Corporation recalls SUPER TORQUE MB angiographic catheters worldwide due to risk of entrapment between endovascular devices and vessel wall, potentially causing marker band dislodgement.

    Product
    Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2430-2021·2021-09-22

    Cordis SUPER TORQUE Angiographic Catheter Recalled for Entrapment Risk

    Cordis is recalling the SUPER TORQUE MB angiographic catheter (18,730 units) due to risk of entrapment between endovascular devices and vessel wall, which can cause marker band movement or dislodgement. Units were distributed worldwide.

    Product
    Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2429-2021·2021-09-22

    Cordis Angiographic Catheter Recall Due to Potential Marker Band Dislodgement

    Cordis is recalling approximately 1,610 SUPER TORQUE PIG PIGTAIL SPECIAL angiographic catheters worldwide because the device can become entrapped between endovascular devices and the vessel wall, potentially causing marker band movement or dislodgement.

    Product
    Cordis 5F SUPER TORQUE PIG PIGTAIL SPECIAL, Angiographic Catheter, REF SRD7040MB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2456-2021·2021-09-22

    FDA recalls BD burette sets for connector valve occlusion and flow defects

    BD Gravity Burette Sets and Add-On Burette Sets are being recalled due to needle-free connector valve defects that may cause flushing difficulties, flow problems, or complete occlusions, potentially delaying therapy. The recall affects approximately 77,802 units distributed worldwide.

    Product
    BD Gravity Burette Set 60 DROP 1.2 MF 2 SmartSite VALVES BALL VALVE DRIP CHAMBER V/NV, REF: 10037031; BD Gravity Burette Set 20 DROP 1.2 Micron Filter 2 SmartSite VALVES BALL VALVE DRIP CHAMBER V/NV , REF: 10037032; BD GRAVITY BURETTE SET 60 DROP 2 Smartsite VALVES BALL DRIP CHAM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2444-2021·2021-09-22

    Roche cobas infinity software may release incorrect test results to laboratories

    Roche Diagnostics is recalling cobas infinity central lab software versions 3.01.03–3.02.08 because under certain circumstances, the software may automatically send false test results to laboratory information systems. Correct results remain available on the instrument.

    Product
    cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001
    Category
    Medical Device
    Distribution
    Distributed nationwide