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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13026–13050 of 13837

  • 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-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-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-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-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-2533-2021·2021-09-29

    Foley Catheter Tray Packaging Defect Poses Sterile Barrier Risk

    C.R. Bard Inc is recalling a Foley catheter tray due to potential packaging defects that may compromise the sterile barrier. Approximately 1,710 units were distributed nationwide.

    Product
    Catalog A897514, SureStep" Foley Tray, Silicone, Drainage Bag, StatLock" Stabilization Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2531-2021·2021-09-29

    C.R. Bard SureStep Foley Catheter Tray Recalled for Sterile Barrier Defect

    C.R. Bard Inc is recalling SureStep Foley Catheter Trays due to potential packaging defects that may compromise the sterile barrier. The recall affects 33,380 units distributed nationwide.

    Product
    Catalog A800361, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
    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
  • 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-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-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-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-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-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-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-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-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-2473-2021·2021-09-22

    McKesson Lap Sponges Recalled for Failed Sterilization Indicator

    Cypress Medical Products is recalling one case of McKesson Lap Sponges due to a failed sterilization indicator that did not change from red to blue, compromising verification of proper sterilization.

    Product
    McKesson Lap Sponge, X-Ray Detectable 12"x 12", 5/pack, Sterile McKesson Part # 16-2112121
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2447-2021·2021-09-22

    MR MAGNETOM Imaging Systems Risk Data Loss in Treatment Planning

    Siemens MR MAGNETOM imaging systems may lose treatment planning data when editing structure sets after reopening a saved study, resulting in incomplete treatment plans being transmitted to planning systems.

    Product
    MR MAGNETOM Systems with RT Image Suite with syngo MR VA20A, VA30A and VA31A with license SW-Key CT_RT_IMA_SUITE_SYNTHETIC_CT Material Numbers: 11060815
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2459-2021·2021-09-22

    BD Alaris Infusion Pump Buerette Sets Needle-Free Connector Valve Issues

    BD Alaris Pump Infusion Buerette Sets with needle-free connector valves may experience flushing difficulties, flow issues, or occlusions that could delay therapy delivery. No illnesses or injuries have been reported.

    Product
    BD Alaris Pump Infusion Buerette Set 0.2 Micron Filter Smallbore Tubing SmartSite Port (Burette) SmartSite Y-Site, REF: 10015012; BD Alaris Pump Infusion Buerette Set Ball Valve Smallbore Tubing Smartsite Port (Burette) SmartSite Y-Site, REF: 10817920; BD Alaris Pump Infusion Bue
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2448-2021·2021-09-22

    Pentax Medical Colonoscopes and Upper GI Scopes Updated Reprocessing Instructions

    Pentax is updating reprocessing instructions for over 28,000 colonoscopes and Upper GI scopes distributed nationwide between 2014 and 2021. Healthcare facilities should implement the updated procedures provided by the manufacturer.

    Product
    Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water Jet Channel Models: EC-2990Li, EC-3490Li, EC-3890Li, EC-3490TLi, EC-3490LK, EC-3890LK, EC3890LZi, EC34-i10L, EC38-i10L; Colonoscope Family # 2-Pentax Video Colonoscopes with Tw
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2477-2021·2021-09-22

    Lyra Direct SARS-CoV-2 Assay Instructions Revised for False Negative Risk

    The Lyra Direct SARS-CoV-2 assay can produce false negatives on certain PCR machines when specimens have high viral loads. Revised instructions address this diagnostic failure risk affecting approximately 81,910 kits distributed worldwide.

    Product
    Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization- Ref: M124. The Lyra Direct SARS-CoV-2 Assay is a real-time RT-PCR assay intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasal (NS), nasopharyngeal (NP), or oropharyngeal (OP) direct swab speci
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2461-2021·2021-09-22

    BD SmartSite Bag Access Device Recalled for Valve Occlusion Issues

    CAREFUSION is recalling BD SmartSite Bag Access Device needle-free connector valves due to potential occlusions and flow issues that could delay therapy delivery.

    Product
    BD SmartSite Bag Access Device, REF: 2300E-0500; BD BAG ACCESS DEVICE CHECK VALVE SmartSite VALVE, REF: 2309E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2475-2021·2021-09-22

    Philips Allura Xper Imaging System Overheating and Malfunction Recall

    Philips Allura Xper imaging systems may fail early when supplied with 480V, causing coil overheating and burning smell. When the system fails, X-ray imaging capability is reduced to emergency mode only.

    Product
    The Allura Xper series is intended for use on human patients to perform: "Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal
    Category
    Medical Device
    Distribution
    Distributed nationwide