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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2126–2150 of 5038

  • SevereFDA (Devices)·Z-1077-2021·2021-02-17

    Argon Medical Devices Recalls Transjugular Liver Biopsy Systems

    Argon Medical Devices is recalling 583 Transjugular Liver Biopsy Systems due to a manufacturing error that may cause the sheath to separate during use.

    Product
    Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18N, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, Sterile EO,
    Category
    Medical Device
    Distribution
    46 states
  • SevereFDA (Devices)·Z-1073-2021·2021-02-17

    Argon Medical Devices Recalls Transjugular Liver Biopsy Systems

    Argon Medical Devices is recalling 863 TLAB Transjugular Liver Biopsy Systems due to a manufacturing error that may cause the sheath to separate during use.

    Product
    Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19, 1/19 GA Flexcore Biopsy Needle, 7F Introducer Sheath W/Curved Metal Stiffener, Tissue Removal Swabs, 5F Straight Catheter, 5F Curved Catheter, Sterile EO,
    Category
    Medical Device
    Distribution
    46 states
  • SevereFDA (Devices)·Z-0925-2021·2021-02-10

    Hill-Rom Liko Multirall 200 Overhead Lifts Recalled for Detachment Risk

    Hill-Rom is recalling Liko Multirall 200 overhead lifts because a strap lock may not fully engage, causing the lift to detach from the rail and potentially drop the patient.

    Product
    Liko Multirall 200 overhead lift- overhead lift is a general-purpose lift with the intended use in healthcare, intensive care and rehabilitation. Affected devices: Liko Multirall 200 (product number 3130001) Universal SlingBar 450 R2R (product number 3156095) Universal Sling
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0946-2021·2021-02-10

    Medtronic HVAD Pump Implant Kits Recalled for Startup Failures

    Heartware, Inc. is recalling 19,562 Medtronic HVAD Pump Implant Kits because they may fail to start or restart at a higher rate than expected.

    Product
    Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, c. PUMP 1104JP, d. PUMP 1100, e. Model 1101, f. Model 1102, g. Model 1104CA-CLIN, h. Model 1205, i. Model MCS1705PU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0612-2020·2021-02-03

    Enztec Femoral Impactor Recall Due to Arm Fracture Risk

    Enztec Limited is recalling 312 femoral impactors used with the DJO EMPOWR 3D KNEE system because the arm may fracture during use, potentially causing surgical delays or inflammatory responses.

    Product
    REF 800-05-035, ENZTEC FEMORAL IMPACTOR - DJO, (01) 09421028110624 (10) 999999, To be used only with DJO EMPOWR 3D KNEE
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0926-2021·2021-02-03

    Medtronic COBALT HF QUAD CRT-D MRI SureScan Recall for Potential Loss of Function

    Medtronic is recalling two specific COBALT HF QUAD CRT-D MRI SureScan devices due to a rare component failure mechanism that could cause loss of function.

    Product
    Medtronic COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therapy, SureScan technology, and Bluetooth wireless telemetry (DDE-DDDR)
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0921-2021·2021-02-03

    OMNIlife Science Recalls SERF Novae Dual Mobility Cup Inserts

    OMNIlife Science Inc. is recalling 3 units of SERF Novae Dual Mobility Cup Inserts due to high oxidation levels that may increase wear rates and require revision surgery.

    Product
    SERF Novae Dual Mobility Cup Insert 47/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-24728
    Category
    Medical Device
    Distribution
    5 states
  • SevereFDA (Devices)·Z-0922-2021·2021-02-03

    OMNIlife Recalls SERF Novae Dual Mobility Cup Inserts Due to Oxidation

    OMNIlife science Inc. is recalling 2 units of SERF Novae Dual Mobility Cup Inserts because they have higher than acceptable oxidation limits, which may increase wear rates and require revision surgery.

    Product
    SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-24928
    Category
    Medical Device
    Distribution
    5 states
  • CriticalFDA (Devices)·Z-0879-2021·2021-01-27

    Boston Scientific Recalls Emblem S-ICD Subcutaneous Electrodes Due to Fracture Risk

    Boston Scientific is recalling Emblem S-ICD Subcutaneous Electrodes because fractures may prevent the device from delivering therapy.

    Product
    EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator (ICD)
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0850-2021·2021-01-27

    Penumbra JET 7 Reperfusion Catheter Recalled for Potential Tip Damage

    Penumbra Inc. is recalling JET 7 Reperfusion Catheters because distal tip damage could cause vessel injury or death during use.

    Product
    Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7L138KIT The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers aspiration from the Aspiration Pu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0849-2021·2021-01-27

    Penumbra JET 7 Reperfusion Catheter Recalled for Potential Vessel Damage

    Penumbra Inc. is recalling JET 7 Reperfusion Catheters because distal tip damage could cause vessel injury or death during use.

    Product
    Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7KIT The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers aspiration from the Aspiration Pump t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0848-2021·2021-01-27

    Penumbra JET 7 Reperfusion Catheter Recalled for Potential Tip Damage

    Penumbra Inc. is recalling 3,368 JET 7 Reperfusion Catheters because the distal tip may become damaged during use, posing a risk of vessel damage and patient injury or death.

    Product
    Penumbra JET 7 Reperfusion Catheter REF 5MAXJET7 The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers aspiration from the Aspiration Pump to the site of occlusion to assist in the ef
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0851-2021·2021-01-27

    Penumbra JET 7MAX Kits Recalled for Potential Vessel Damage Risk

    Penumbra Inc. is recalling JET 7MAX Kits because catheter tip damage during use could cause vessel damage, leading to patient injury or death.

    Product
    Penumbra JET 7MAX KIT Penumbra JET 7 Reperfusion Catheter+ MAX Delivery Device + Hi-Flow Aspiration Tubing REF J7XKIT132 The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers aspirat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0872-2021·2021-01-27

    Medtronic Recalls Neonatal Delta Valve Shunt Assemblies Due to Catheter Defect

    Medtronic is recalling Neonatal Delta Valve Shunt Assemblies because a manufacturing defect may cause the ventricular catheter to disconnect from the valve, leading to shunt malfunction.

    Product
    REF 27219-2 X1, Medtronic, Delta Valve, Neonatal, Performance Level 2.0, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies are components of CSF-Flow Control Shunt Systems designed to provide controlled CSF flow from the ventricles of the brain into the p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0871-2021·2021-01-27

    Medtronic Recalls Neonatal Delta Valve Shunt Assemblies Due to Catheter Defect

    Medtronic is recalling 95 Neonatal Delta Valve Shunt Assemblies because a manufacturing defect may cause the ventricular catheter to disconnect from the valve, leading to shunt malfunction.

    Product
    REF 27219-1 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.0, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies are components of CSF-Flow Control Shunt Systems designed to provide controlled CSF flow from the ventricles of the brain into the p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0873-2021·2021-01-27

    Medtronic Recalls Neonatal Delta Valve Shunt Assemblies Due to Catheter Defect

    Medtronic is recalling specific Neonatal Delta Valve Shunt Assemblies because a manufacturing defect may cause the ventricular catheter to disconnect, leading to shunt malfunction.

    Product
    REF 27219-5 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.5, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies are components of CSF-Flow Control Shunt Systems designed to provide controlled CSF flow from the ventricles of the brain into the p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0876-2021·2021-01-27

    Steris Reliance Vision Washer/Disinfector Recalled for Fire Risk

    Steris is recalling Reliance Vision Single-Chamber Washer/Disinfector units because a faulty electrical contactor may cause the drying chamber to overheat, potentially leading to smoke or fire.

    Product
    Reliance Vision Single-Chamber Washer/Disinfector - Product Usage: intended for use in the cleaning and intermediate level disinfection of soiled reusable utensils, trays, glassware, bedpans and urinals, rubber and plastic goods, simple hard-surfaced rigid surgical instruments, s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0868-2021·2021-01-27

    Laerdal Compact Suction Unit Recalled for Potential Suction Loss

    Laerdal Medical is recalling 5,035 Compact Suction Units (LCSU 4) because component failures may cause the device to lose suction, potentially delaying treatment or causing suffocation.

    Product
    Laerdal Compact Suction Unit (LCSU 4), Catalog Numbers 880051, 880061, 881151, 880052, 880062, 881152 - Product Usage: It is intended for intermittent operation to remove secretions, blood or vomit from a patient s airway to allow ventilation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0829-2021·2021-01-20

    Fresenius Citrasate Liquid Acid concentrate drums recalled for low sodium levels

    Fresenius Medical Care is recalling 176 drums of Citrasate Liquid Acid concentrate because sodium and/or calcium levels were below manufacturing specifications.

    Product
    Citrasate Liquid Acid concentrate drums, Model Number 13-3251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0656-2021·2021-01-20

    Siemens Artis Medical Imaging Systems Recalled for Radiation Safety Defect

    Siemens is recalling Artis zee, Artis Q, and Artis Pheno systems because the Air Kerma Rate can exceed regulatory limits when frame rates are increased during continuous release.

    Product
    Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0736-2021·2021-01-20

    Boston Scientific Recalls Lotus Edge Valve Systems Due to Release Failure Risk

    Boston Scientific is recalling 386 Lotus Edge Valve Systems because a visual inspection error could prevent the delivery system from releasing during deployment.

    Product
    Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 27mm, sterile, REF H749LVS270, GTIN 08714729940838, Made in Ireland, Ballybrit Business Park, Galway, Ireland.
    Category
    Medical Device
    Distribution
    38 states
  • SevereFDA (Devices)·Z-0735-2021·2021-01-20

    Recall of Lotus Edge Valve System Transcatheter Aortic Valve Prosthesis Due to Deployment Locking Failure

    Boston Scientific recalls 278 Lotus Edge Valve Systems due to a failure in visual inspection that prevents proper valve locking during deployment, potentially preventing delivery system release.

    Product
    Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile, REF H749LVS250, GTIN 08714729940821, Made in Ireland, Ballybrit Business Park, Galway, Ireland.
    Category
    Medical Device
    Distribution
    38 states
  • SevereFDA (Devices)·Z-0728-2021·2021-01-20

    Boston Scientific Recalls Lotus Edge Valve Systems Due to Deployment Failure Risk

    Boston Scientific is recalling 219 Lotus Edge Valve Systems because a visual inspection error could prevent the delivery system from releasing during deployment.

    Product
    Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile, REF H749LVSUS230, GTIN 08714729960904
    Category
    Medical Device
    Distribution
    38 states
  • SevereFDA (Devices)·Z-0729-2021·2021-01-20

    Boston Scientific Recalls Lotus Edge Valve Systems Due to Deployment Defect

    Boston Scientific is recalling 319 Lotus Edge Valve Systems because a visual inspection failure may prevent the delivery system from releasing during deployment.

    Product
    Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile, REF H749LVSUS250, GTIN 08714729960911, Made in Ireland, Ballybrit Business Park, Galway, Ireland.
    Category
    Medical Device
    Distribution
    38 states
  • SevereFDA (Devices)·Z-0831-2021·2021-01-20

    Fresenius Naturalyte Liquid Acid concentrate bottles recalled for conductivity deviation

    Fresenius Medical Care is recalling Naturalyte Liquid Acid concentrate bottles due to conductivity deviations and calcium concentration below specification.

    Product
    Naturalyte Liquid Acid concentrate bottles, Product Code 08-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide