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.

Filters

Agency

Category

Minimum severity

Clear filters

11901–11925 of 27470

  • HighFDA (Devices)·Z-1373-2021·2021-04-14

    Beckman Coulter Recalls MicroScan WalkAway-96 plus Reconditioned Instruments

    Beckman Coulter is recalling nine MicroScan WalkAway-96 plus Reconditioned Instruments due to a shortened reagent draw straw that may cause reagent dispensing failures and organism misidentification.

    Product
    MicroScan WalkAway-96 plus Reconditioned Instrument
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1368-2021·2021-04-14

    Medtronic A610 Clinician Programmer Software Recall for Deep Brain Stimulation

    Medtronic is recalling A610 Clinician Programmer software versions 2.0.4584, 2.0.4594, 2.0.4605, and 3.0.1057 due to software errors that prevent proper copying of cycling settings and cause application crashes when reading full system event logs.

    Product
    A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming Guide Percept PC Model B35200 Neurostimulator Application, version 2.0.4584, 2.0.4594, 2.0.4605, and 3.0.1057* * Version 3.0.1057 is approved for distribution in Europe only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1367-2021·2021-04-14

    Terumo Sternal Retractor Locking Mechanism Recall for Fracture Risk

    Terumo is recalling 12 sternal retractor devices because the stainless steel locking plates may fracture. The devices were distributed in eight US states.

    Product
    Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or Terumo Shaft Quick Connect), an articulating arm with links, a handle for providing cable tension, and a mechanism to mount the device to a sternal retractor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1334-2021·2021-04-07

    CF Delivery Dev Caps Bravo x5 Recalled for Aspiration Risk

    FDA recalls CF Delivery Dev Caps Bravo x5 capsules because they may fail to attach to the esophagus, leading to aspiration.

    Product
    CF Delivery Dev Caps Bravo x5, FGS-0635/FGS 0636 - Product Usage: intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1335-2021·2021-04-07

    FDA Recalls Bravo pH Capsule Delivery Devices Due to Aspiration Risk

    The FDA is recalling Bravo pH Capsule Delivery Devices because the capsule may fail to attach to the esophagus, leading to aspiration and potential hospitalization.

    Product
    BRAVO PH CAPS DELIVERY DEV5-PK, FGS-0312/FGS-0313 - Product Usage: intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1313-2021·2021-04-07

    Medtronic Bio-Console 560 Blood Pumping Console Recalled for Electrical Failure

    Medtronic is recalling Bio-Console 560 devices because an electrical component may fail, causing the pump to stop and potentially producing smoke or a burning odor.

    Product
    Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers: 560BC, 560BC1, 560BCS, 560BCS1, R560BCS1. Used in cardiopulmonary bypass (CPB) procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1259-2021·2021-04-07

    Smisson-Cartledge ThermaCor 1200 Disposable Sets Recalled for Aluminum Leaching Risk

    Smisson-Cartledge Biomedical is recalling ThermaCor 1200 Disposable Sets due to a toxicological risk assessment indicating potential aluminum ion leaching into warmed fluids.

    Product
    ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood product, including packed red blood cells, as volume replacement for patients suffering from…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1330-2021·2021-04-07

    Siemens ACUSON Sequoia Ultrasound Systems Recalled for Incorrect Delivery Date Calculations

    Siemens is recalling 1,172 ACUSON Sequoia ultrasound systems because a software error may calculate incorrect Estimated Dates of Delivery, potentially influencing clinical decisions.

    Product
    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-1323-2021·2021-04-07

    Nuvasive PRECICE STRYDE Intramedullary Nail Recall for Biological Safety Concerns

    Nuvasive Specialized Orthopedics is recalling PRECICE STRYDE intramedullary nails due to complaints of adverse events potentially related to biological safety, including pain and bony abnormalities.

    Product
    PRECICE STRYDE - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1258-2021·2021-04-07

    ThermaCor 1200 Disposable Sets Recalled for Potential Aluminum Leaching

    Smisson-Cartledge Biomedical is recalling ThermaCor 1200 Disposable Sets because a toxicological assessment found potential for aluminum ions to leach into warmed fluids.

    Product
    ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood product, including packed red blood cells, as volume replacement for patients suffering from blood…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0317-2021·2021-04-07

    Ferring Recalls ZOMA-Jet 5 Demonstration Kits Due to Defective Delivery System

    Ferring Pharmaceuticals is recalling 301 ZOMA-Jet 5 Demonstration Kits because the injector pen may break apart and disintegrate into pieces.

    Product
    ZOMA-Jet 5 Demonstration Kit, Needle-free delivery device for use with ZOMACTON (somatropin) for injection 5mg vial, Rx only, ZOMA-Jet 5 Demonstration Kit contains -ZOMA-Jet 5 device - 5 Needle-Free Head A's - 2 Vial Adaptors - 1 Carrying Case - 1 User Manual; Manufactured for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1305-2021·2021-04-07

    Medtronic Recalls Implantable Cardioverter Defibrillators Due to Shortened Replacement Time

    Medtronic is recalling specific Evera and Visia ICD models because a small percentage may experience a shortened Recommended Replacement Time to End of Service interval.

    Product
    Implantable cardioverter defibrillators (ICD): 1) Evera family: Evera XT DR, Evera S DR, Evera MRI XT DR, Evera MRI S DR, Evera XT VR, Evera S VR and Evera MRI S VR models; 2) Visia family: Visia AF ICD, Visia AF S ICD, Visia AF MRI ICD, and Visia AF MRI S ICD models.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1260-2021·2021-04-07

    ThermaCor 1200 Disposable Sets Recalled for Potential Aluminum Leaching

    Smisson-Cartledge Biomedical is recalling ThermaCor 1200 Disposable Sets due to a toxicological risk assessment indicating potential aluminum ion leaching into warmed fluids.

    Product
    ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood product, including packed red blood cells, as volume replacement for patients suffering from…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1318-2021·2021-04-07

    EPIX Therapeutics Recalls DiamondTemp Ablation Catheters Due to Labeling Errors

    EPIX Therapeutics is recalling 60 units of DiamondTemp Unidirectional Large Curve Ablation Catheters because packaging and instructions list incorrect catheter sizes, posing a risk of blood clots or air emboli.

    Product
    EPIX Therapeutics DiamondTemp Unidirectional Large Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF: CEDT200L, Sterile EO, UDI: 00812499030259
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1320-2021·2021-04-07

    EPIX Therapeutics Recalls DiamondTemp Ablation Catheters Due to Labeling Errors

    EPIX Therapeutics is recalling 18 units of DiamondTemp Bidirectional Large Curve Ablation Catheters because packaging and instructions list incorrect sizes, posing a risk of blood clots or air emboli.

    Product
    EPIX Therapeutics DiamondTemp Bidrectional Large Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:CEDTB400L, SterileEO, UDI: 00812499030303
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1324-2021·2021-04-07

    Nuvasive Precice Bone Transport Nail Recalled for Biological Safety Concerns

    Nuvasive Specialized Orthopedics is recalling 226 Precice Bone Transport nails due to complaints of pain and bony abnormalities related to biological safety.

    Product
    Precice Bone Transport - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1328-2021·2021-04-07

    Alcon Custom Ophthalmic Surgical Procedure Packs Recalled for Mold

    Alcon is recalling 249,853 custom ophthalmic surgical procedure packs because mold was found on gowns included in the packages.

    Product
    Alcon Custom Ophthalmic Surgical Procedure Packs
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1317-2021·2021-04-07

    EPIX Therapeutics Recalls DiamondTemp Ablation Catheters Due to Labeling Errors

    EPIX Therapeutics is recalling 100 units of DiamondTemp Unidirectional Small Curve Ablation Catheters because packaging and instructions list incorrect catheter sizes, posing a risk of blood clots or air emboli.

    Product
    EPIX Therapeutics DiamondTemp Unidirectional Small Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF CEDT100S, SterileEO, UDI 00812499030198
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1342-2021·2021-04-07

    Diasorin Recalls LIAISON 1-84 PTH Assay Due to Falsely Elevated Results

    Diasorin Inc. is recalling LIAISON 1-84 PTH Assay kits because the system may produce falsely elevated parathyroid hormone results.

    Product
    LIAISON 1-84 PTH Assay - Product Usage: is an in vitro chemiluminescent immunoassay (CLIA) intended for the quantitative determination of parathyroid hormone (1-84) in human serum and EDTA plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1325-2021·2021-04-07

    Nuvasive Recalls PRECICE Plates Due to Biological Safety Concerns

    Nuvasive Specialized Orthopedics Inc is recalling 40 PRECICE Plate units worldwide due to complaints of adverse events potentially related to biological safety.

    Product
    PRECICE PLATE - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1319-2021·2021-04-07

    EPIX Therapeutics Recalls DiamondTemp Ablation Catheters Due to Labeling Errors

    EPIX Therapeutics is recalling 15 DiamondTemp Bidirectional Small Curve Ablation Catheters because the packaging and instructions for use list incorrect catheter sizes.

    Product
    EPIX Therapeutics DiamondTemp Bidrectional Small Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:CEDTB300S, SterileEO, UDI: 00812499030358
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1333-2021·2021-04-07

    Biocare Medical IntelliPath FLX Automated Staining Instrument Recall

    Biocare Medical is recalling 72 IntelliPath FLX instruments due to a software defect that may cause random movement and buffer dispensing errors.

    Product
    BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: " Model Number:IPS0001US and IPS0001INTL containing software version 3.5.3.1
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1306-2021·2021-04-07

    Medtronic Recalls CRT-D Devices Due to Shortened Replacement Time

    Medtronic is recalling specific CRT-D implantable cardioverter defibrillators because a small percentage may experience a shortened time before the device reaches end of service.

    Product
    Implantable cardioverter defibrillators (ICD) with cardiac resynchronization therapy (CRT-D): 1) Viva family: Viva XT CRT-D, Viva XT Quad CRT-D, Viva S CRT-D, Viva Quad S CRT-D and Viva Quad C CRT-D models; 2) Claria family: Claria MRI CRT-D and Claria MRI Quad CRT-D models; 3)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1309-2021·2021-04-07

    CareFusion Recalls BD Alaris Infusion Pump Keypads Due to Fluid Ingress

    CareFusion is recalling BD Alaris Infusion Pump Module Keypads and Door Assembly Kits because fluid ingress can cause unresponsive or stuck keys, potentially delaying medication infusion.

    Product
    BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module Door Assembly Replacement Kit with Pump Module Keypad, Parts: 49000239; 49000346; 49000438; 49000439.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1311-2021·2021-04-07

    Hollister Recalls Vertical Drain Tube Attachment Devices Due to Separation Risk

    Hollister Incorporated is recalling Vertical Drain Tube Attachment Devices (VTAD) because the tube holder can separate from the securing barrier, risking tube migration or loss.

    Product
    Vertical Drain Tube Attachment Device (VTAD) (Gastrointestinal tube and accessories) - Product Usage: designed to stabilize and secure a variety of catheters, surgical drains, and tubes from sizes 5-40 French.
    Category
    Medical Device
    Distribution
    Distributed nationwide