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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2451–2475 of 5038

  • SevereFDA (Devices)·Z-1786-2020·2020-04-29

    Degania Recalls Temperature Sensing Foley Catheters Due to Inspection Failures

    Degania Medical Devices is recalling specific lots of temperature sensing Foley catheters because inadequate incoming inspection practices were used on the thermistor sensors.

    Product
    Temperature Sensing 100% Silicone Foley Catheter, Part Number 102202101863DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1746-2020·2020-04-29

    Wilson-Cook Recalls HEMO-10 Hemospray Endoscopic Hemostat Devices

    Wilson-Cook Medical is recalling HEMO-10 Hemospray Endoscopic Hemostat devices because the handle or activation knob may crack or break, potentially causing the carbon dioxide cartridge to exit the handle.

    Product
    HEMO-10 Hemospray Endoscopic Hemostat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1769-2020·2020-04-29

    Acutus Medical AcQGuide Introducer Recalled for Foreign Material Particulates

    Acutus Medical Inc is recalling 268 units of AcQGuide Mini Fixed-Curve Introducers because manufacturing defects may have left foreign material on the devices.

    Product
    Acutus Medical AcQGuide Mini Fixed-Curve Introducer with AcQCros QX Integrated Dilator/Transseptal Needle, Ref: 112852 Sterile EO, RxOnly
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1745-2020·2020-04-29

    Wilson-Cook Recalls HEMO-7 Hemospray Endoscopic Hemostat Devices

    Wilson-Cook Medical is recalling HEMO-7 Hemospray Endoscopic Hemostat devices because the handle or activation knob may crack or break during activation, potentially causing the carbon dioxide cartridge to exit the handle.

    Product
    HEMO-7 Hemospray Endoscopic Hemostat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1770-2020·2020-04-29

    Acutus Medical Recalls Rhythm Xience Flextra Steerable Introducers Due to Foreign Material

    Acutus Medical Inc is recalling 30 units of Rhythm Xience Flextra Steerable Introducers because manufacturing defects may have left foreign material particulates on the devices.

    Product
    Rhythm Xience Flextra Steerable Introducer with Lancer Integrated Dilator/Transseptal Needle, REF: 122852, Sterile EO, RxOnly
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1700-2020·2020-04-22

    Abbott Recalls Merlin PCS 3650 Software Upgrade Kit Due to Anomaly

    Abbott is recalling the Merlin PCS 3650 Software Upgrade Kit because a software anomaly may cause the device to use a previously programmed shock energy level without alerting the user.

    Product
    Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The MerlinTM Patient Care System (MerlinTM PCS) Model 3650 is a portable, dedicated programming system designed to interrogate, program, display data, and test St. Jude MedicalTM implantable devices and leads.
    Category
    Medical Device
    Distribution
    40 states
  • SevereFDA (Devices)·Z-1717-2020·2020-04-22

    Sysmex CV-11 Sample Unit Recalled for Combustion Hazard

    Sysmex America is recalling 40 CV-11 Sample Units because urine spills on the transport track can reach electrical components, creating a potential for smoke, sparks, and combustion.

    Product
    Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens to either the UF-5000 or UD-10 analyzers.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1629-2020·2020-04-15

    Zeiss Laser Scanning Microscope Component Recalled for Laser Safety Bypass

    Zeiss is recalling a component for LSM 700, 800, and 900 microscopes because tilting the light arm can bypass laser safety, causing Class IIIB laser radiation emission.

    Product
    Component for Laser Scanning Microscopes (LSM 700, LSM 800 and LSM 900)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1679-2020·2020-04-15

    Siemens ONCOR Radiation Therapy Systems Recalled for Potential Dose Overdose

    Siemens is recalling specific ONCOR radiation therapy systems due to a potential safety issue with dose monitoring interlocks that could result in a 10-20% overdose.

    Product
    ONCOR Avante Garde #5863472, ONCOR Expression #7360717, ONCOR Impression #5857920, ONCOR Impression Plus #5857912 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
    Category
    Medical Device
    Distribution
    35 states
  • SevereFDA (Devices)·Z-1678-2020·2020-04-15

    Siemens Medical Solutions Recalls MEVATRON Radiation Therapy Systems

    Siemens Medical Solutions is recalling specific MEVATRON radiation therapy systems due to a potential safety issue with dose monitoring interlocks that could result in a 10-20% radiation overdose.

    Product
    MEVATRON M2/Primus Mid-Energy Model #01940035, MEVATRON PRIMART #05500371, MEVATRON KD-2 #08515520, MEVATRON KD2 #01940753, MEVATRON M-2 6740 #09401506, MEVATRON MD-2 #09401654, MEVATRON MDX-2 #09401746 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
    Category
    Medical Device
    Distribution
    35 states
  • SevereFDA (Devices)·Z-1680-2020·2020-04-15

    Siemens PRIMUS HI Linear Accelerators Recalled for Radiation Overdose Risk

    Siemens is recalling PRIMUS HI linear accelerators because a safety interlock defect could cause a 10-20% overdose of radiation therapy.

    Product
    PRIMUS HI #04504200 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
    Category
    Medical Device
    Distribution
    35 states
  • SevereFDA (Devices)·Z-1677-2020·2020-04-15

    Siemens ARTISTE MV System Recalled for Radiation Dose Monitoring Safety Interlock Defect

    Siemens is recalling ARTISTE MV Systems due to a potential safety issue with dose monitoring interlocks that could result in a 10-20% radiation therapy overdose.

    Product
    ARTISTE MV System Model #8139789 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
    Category
    Medical Device
    Distribution
    35 states
  • SevereFDA (Devices)·Z-1567-2020·2020-04-08

    LeMaitre Embolectomy Catheter Recall for Deflation Failure and Tip Separation

    LeMaitre Vascular is recalling 5F Plus Over the Wire Embolectomy Catheters due to reports of deflation failure that may lead to tip separation.

    Product
    LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88, e1651-88. The LeMaitre Over the Wire Embolectomy Catheter is indicated for use in the removal of emboli and thrombi during embolectomy and/or thrombectomy. It can also be used for cathe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1602-2020·2020-04-08

    Stryker Recalls Ceiling Mounted Surgical Light Systems Due to Fall Risk

    Stryker is recalling 1,415 Berchtold Chromophare Ceiling Mounted Surgical Light Systems because a missing snap ring or spanner nut may cause the light to fall.

    Product
    Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1632-2020·2020-04-08

    Merits E604 Pilot Navigator Stairlift Recalled Due to Pinion Gear Defect

    Merits Health Products is recalling 82 E604 Pilot Navigator Stairlifts because the pinion gear may disengage from the track, allowing the lift to slip or jolt.

    Product
    Merits E604 Pilot Navigator Stairlift - Product Usage: To transport patients up stairs.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1622-2020·2020-04-08

    Philips V60 Ventilators Recalled for Power Management Board Failure

    Respironics is recalling 23,581 Philips V60 Ventilators because a solder connection failure on the power board may cause the blower to lose power or shut down unexpectedly, potentially leading to hypercarbia or hypoxemia.

    Product
    Philips V60 Ventilators with Power Management PCBA part number 1055906
    Category
    Medical Device
    Distribution
    53 states
  • SevereFDA (Devices)·Z-1589-2020·2020-04-01

    Medtronic MiniMed Paradigm Insulin Pumps Recalled for Cybersecurity Vulnerabilities

    Medtronic MiniMed is recalling 38 Paradigm insulin pumps due to cybersecurity vulnerabilities that could allow unauthorized wireless control of insulin delivery.

    Product
    Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1587-2020·2020-04-01

    Medtronic MiniMed Paradigm Insulin Pumps Recalled for Cybersecurity Vulnerabilities

    Medtronic MiniMed is recalling 88,243 Paradigm insulin pumps due to cybersecurity vulnerabilities that could allow unauthorized wireless control of insulin delivery.

    Product
    Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1527-2020·2020-04-01

    ev3 Pipeline Flex Embolization Device Recalled for Potential Fracture

    Micro Therapeutics Inc is recalling 1,050 ev3 Pipeline Flex Embolization Devices because the delivery system may fracture during implantation, potentially leaving a part in the patient.

    Product
    ev3 Pipeline Flex Embolization Device. For neurological endovascular use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1591-2020·2020-04-01

    Medtronic MiniMed Paradigm Insulin Pump Recalled for Cybersecurity Vulnerabilities

    Medtronic MiniMed is recalling 23,221 Paradigm insulin pumps due to cybersecurity vulnerabilities that could allow unauthorized wireless control of insulin delivery.

    Product
    Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1499-2020·2020-03-25

    Philips Recalls HeartStart MRx Defibrillators Due to Internal Damage Risk

    Philips is recalling HeartStart MRx Monitor/Defibrillators because internal damage from drops or shocks may prevent therapy delivery, even if the device appears undamaged.

    Product
    HeartStart MRx Monitor/Defibrillators with model numbers M3535A M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, and M3536M9.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1508-2020·2020-03-25

    Stryker Strykeprobe Outer Sheath Recalled for Potential Electrical Hazard

    Stryker is recalling 525 Strykeprobe Outer Sheath Replacement devices due to a potential length mismatch that could cause sheath melting and unintended electrical flow to patients.

    Product
    Stryker, REF: 0250070460, 5.0 mm x 32 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Sterile, CE, UDI: (01) 07613327051971 These products are distributed with the following sheath/probe: 0250070441-PKG, StrykeFlow Electrocautery Probe, Spatula Tip 5MM 0250070442-PK
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1506-2020·2020-03-25

    TeDan Surgical Innovations Recalls Quick Start Distraction Screws Due to Packaging Damage

    TeDan Surgical Innovations is recalling sterile distraction screws because damaged packaging may have exposed them to non-sterile conditions, posing an infection risk.

    Product
    DS-0024 QUICK START DISTRACTION SCREW 14MM 5/BOX STERILE - Product Usage: These products are intended to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1474-2020·2020-03-25

    CME America BodyGuard Infusion Pump Systems Recalled for Delivery Inaccuracy

    CME America is recalling BodyGuard Infusion Pump Systems because they may deliver drugs at inaccurate rates, potentially causing faster or slower than expected medication administration.

    Product
    CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG 545, BG CV545, BG 575, BG CV575, and CMExpress
    Category
    Medical Device
    Distribution
    45 states