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 the agency’s own highest classification or reported deaths or serious injuries, 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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14726–14750 of 40112

  • HighFDA (Devices)·Z-1523-2021·2021-05-12

    Medtronic Recalls CRT-P Quad Models Due to Software Longevity Error

    Medtronic is recalling 45,411 CRT-P Quad implantable devices worldwide because a software issue overestimates battery longevity for six months before replacement is due.

    Product
    CRT-P Quad Models (CRT-Ps): a. Percepta CRT-P MRI: W1TR01, W1TR04, W4TR01, W4TR04 b. Serena CRT-P MRI: W1TR02, W1TR05, W4TR02, W4TR05 c. Solara CRT-P MRI: W1TR03, W1TR06, W4TR03, W4TR06. implantable medical devices used to treat arrhythmias related to bradycardia, and…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1535-2021·2021-05-12

    Medtronic Intellis Recharger Recalled for Potential Unintended Heating

    Medtronic is recalling 79,616 Intellis Model 97755 Rechargers worldwide due to a potential for unintended heating.

    Product
    Intellis Model 97755 Recharger - Product Usage: designed to charge the following Medtronic rechargeable neurostimulators:  Intellis with AdaptiveStim Technology Model 97715 Implanted Neurostimulator  Intellis Model 97716 Implanted Neurostimulator.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1526-2021·2021-05-12

    Medtronic Recalls CRT-P Pacemakers Due to Longevity Estimation Error

    Medtronic is recalling specific implantable cardiac resynchronization therapy pacemakers because a longevity estimation error may occur in the early years of device life.

    Product
    Implantable cardiac resynchronization therapy pacemakers (CRT-P) - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure. 1. Percepta family: Percepta…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1532-2021·2021-05-12

    Medtronic Abre Venous Self-expanding Sent System Recall for Incorrect Size Labeling

    Medtronic is recalling 23 Abre Venous Self-expanding Sent Systems because the device size is incorrectly printed on the device itself, though the packaging is labeled correctly.

    Product
    Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U16080090 - Product Usage: intended for use in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1525-2021·2021-05-12

    Medtronic Recalls Implantable Pulse Generators Due to Longevity Estimation Error

    Medtronic is recalling implantable pulse generators because a longevity estimation error may occur in early device life when specific pacing vectors are programmed.

    Product
    Implantable Pulse Generators - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure. 1. Azure family: Azure XT DR MRI SureScan", Azure S DR MRI…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1527-2021·2021-05-12

    Medtronic Programmers Recalled for Longevity Estimation Error

    Medtronic is recalling 2090 Carelink and 29901 Encore programmers due to a potential longevity estimation error in specific pacing configurations.

    Product
    Programmers - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure. 1. 2090 Carelink 2. 29901 Encore
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1529-2021·2021-05-12

    LeMaitre Vascular Recalls LeverEdge Contrast Injectors Due to Packaging Particulates

    LeMaitre Vascular is recalling 616 LeverEdge Contrast Injectors because particulates in the packaging foam could contaminate the sterile field.

    Product
    LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Product Usage: intended to be used to perfuse contrast medias into the vessels for angiographic procedures, Catalog #: 4100-00.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1521-2021·2021-05-12

    Oto Med Recalls SpineX Bone Dust Collectors Due to Sterile Pouch Defects

    Oto Med Inc is recalling 415 SpineX Bone Dust Collectors because holes were found in the sterile Tyvek pouches during internal testing.

    Product
    Grace Medical REF S-4500 *** spineX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1520-2021·2021-05-12

    Oto Med Recalls Bone Dust Collectors Due to Sterile Pouch Defects

    Oto Med Inc is recalling 5,092 Grace Medical Cox Bone Dust Collectors because holes were found in the sterile Tyvek pouches during internal testing.

    Product
    Grace Medical REF S-3500 *** COX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1519-2021·2021-05-12

    Oto Med Recalls Sheehy Bone Dust Collectors Due to Packaging Defects

    Oto Med Inc is recalling 13,335 Sheehy Bone Dust Collectors because holes were found in the sterile Tyvek pouches during internal testing.

    Product
    Grace Medical REF S-2500 *** SHEEHY BONE DUST COLLECTOR *** Stainless steel filter - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1524-2021·2021-05-12

    DJO EMPOWR KNEE Femoral Sizer Recalled Due to Incorrect Assembly

    Encore Medical is recalling 16 DJO EMPOWR KNEE Femoral Sizers because incorrect assembly caused the size-indicating windows to face the wrong direction.

    Product
    DJO EMPOWR KNEE Femoral Sizer
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1528-2021·2021-05-12

    Medtronic Recalls CareLink SmartSync Device Manager for Longevity Error

    Medtronic is recalling 16,311 CareLink SmartSync Device Manager units worldwide due to a potential longevity estimation error when specific pacing vectors are programmed.

    Product
    CareLink SmartSync Device Manager - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure, Model Number 24970A
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1496-2021·2021-05-05

    Siemens Recalls Artis Angiography Systems Due to Belt Corrosion

    Siemens is recalling 3,320 Artis angiography systems in the US because belt corrosion may cause system failure or unintended C-Arm movement.

    Product
    Artis systems - Product Usage: an angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Model Numbers: System Material # AXIOM Artis FC 05904433…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1498-2021·2021-05-05

    ConMed Infinity Tray Custom Procedural Kit Recalled for Misaligned Guides

    ConMed Corporation is recalling two Infinity Tray Custom Procedural Kits in Canada and Italy because the tip guides may be misaligned, potentially affecting surgical accuracy.

    Product
    INFINITY_TRAY Custom Procedural Kit - Canada. containing Infinity ACL Tibial Elbow and Tip Guides product line, KTE100 and KTT100. For use in open and arthroscopic procedures for knee ligament reconstruction. The procedural kits have no kit specific labeling. Each product…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1509-2021·2021-05-05

    B. Braun Recalls Filtered Triple-Leg Extension Sets Due to Occlusion Risk

    B. Braun Medical is recalling 1,900 Filtered Triple-Leg Extension Sets because they may become occluded or unable to prime.

    Product
    Filtered Triple-Leg Extension Set - Intravascular administration set. Product Catalog number: 477034 - Product Usage: The extension set is a sterile, single-use intravascular direct injection, intermittent infusion, continuous infusion or aspiration of fluids and medications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1488-2021·2021-05-05

    Luminex VERIGENE Processor SP Recalled for Potential False-Negative Pathogen Results

    Luminex is recalling VERIGENE Processor SP units because they may produce false-negative results for specific enteric pathogens when used with the VERIGENE Enteric Pathogens Nucleic Acid Test Kit.

    Product
    VERIGENE Processor SP - Product Usage: intended for processing and identifying nucleic acids utilizing gold nanoparticle probe technology.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1487-2021·2021-05-05

    Baxter Spectrum IQ Infusion Pump Recalled for Defective AC Power Adapter

    Baxter Healthcare is recalling 408 Spectrum IQ infusion pumps because a potentially defective AC power adapter may fail over time.

    Product
    Spectrum IQ - Infusion Pump - Product Usage: intended to be used for the controlled administration of fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1512-2021·2021-05-05

    Donjoy Ultrasling Pro Arm Sling Recalled for Failed Rivet

    DJ Orthopedics is recalling Donjoy Ultrasling Pro arm slings because a rivet at the chafe tab failed, potentially compromising the device's ability to immobilize the arm.

    Product
    DONJOY REF:11-0471-9 ULTRASLING PRO ER/IR 15, UNIVERSAL, Rx ONLY, UDI: (01) 00190446683667 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1503-2021·2021-05-05

    Trinity Biotech Captia Measles IgM Kit Recalled for Invalid Run Risk

    Clark Laboratories is recalling 80 kits of the Trinity Biotech Captia Measles IgM Kit because the positive control may run high, resulting in invalid runs and necessitating retesting.

    Product
    Trinity Biotech Captia Measles IgM Kit, Catalog No. 2326060 - Product Usage: intended for the qualitative detection of Measles igM antibodies in human serum of patients suspected of measles (rubeola) infection.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1499-2021·2021-05-05

    ConMed Infinity ACL Tibial Guides Recalled for Potential Misalignment

    ConMed Corporation is recalling three Infinity ACL Tibial Elbow and Tip Guides due to potential lateral misalignment that could affect surgical accuracy.

    Product
    KIT_INFINITY_BASE Custom Procedural Kit - Italy, containing Infinity ACL Tibial Elbow and Tip Guides product line, KTE100 and KTT100. For use in open and arthroscopic procedures for knee ligament reconstruction The procedural kits have no kit specific labeling. Each…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1506-2021·2021-05-05

    Datascope Cardiosave Hybrid IABP Recalled for Cybersecurity Vulnerabilities

    Datascope Corp. is recalling Cardiosave Hybrid IABP devices due to cybersecurity vulnerabilities in a TCP/IP software library that may cause loss of communication to hospital systems.

    Product
    Cardiosave Hybrid IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation, Model Numbers 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1513-2021·2021-05-05

    DJ Orthopedics Recalls Ultrasling Pro Arm Sling Due to Failed Rivet

    DJ Orthopedics is recalling Ultrasling Pro arm slings because a rivet at the chafe tab failed. The defect could compromise the device's ability to immobilize the arm.

    Product
    DONJOY REF:11-0472-9 ULTRASLING PRO ER/IR 30, UNIVERSAL, Rx ONLY, UDI: (01)00190446683674 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1490-2021·2021-05-05

    Boston Scientific Recalls Colpassist Vaginal Positioning Device Due to Sterility Risk

    Boston Scientific is recalling Colpassist Vaginal Positioning Devices due to potential pinholes that may compromise sterility and cause post-operative infection.

    Product
    Colpassist Vaginal Positioning Device - Product Usage: intended for use in general gynecological surgery to assist in the positioning and manipulation of the vagina during the procedure. Material No. M0068318210
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1491-2021·2021-05-05

    Boston Scientific Recalls Upsylon Y Mesh Kit Due to Sterility Concerns

    Boston Scientific is recalling Upsylon Y Mesh Kits because pinholes may breach the sterile barrier, potentially rendering the device non-sterile and causing post-operative infection.

    Product
    UpsylonTM Y Mesh Kit with Colpassist Vaginal Positioning Device - Product Usage: intended for use as a bridging material for sacrocolposuspension/sacrocolpopexy (laparotomy, laparoscopic or robotic approach Material No.M0068318220 Individually packaged Upsylon Y Mesh (UPN…
    Category
    Medical Device
    Distribution
    Distributed nationwide