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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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

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All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

3776–3800 of 5038

  • SevereFDA (Devices)·Z-0727-2017·2016-12-14

    AMD-Ritmed Transparent Dressing Recalled for Sterility Failure

    AMD-Ritmed is recalling Lot 68408 of transparent dressings because FDA testing found the sterile products were contaminated.

    Product
    AMD-Ritmed Transparent Dressing - Window with label, 4 " x 4 3/4" (10 cm x 12 cm), Reorder No./Code A60044-W, Sterile -- 200 Dressings per case -- Made in China for AMD-Ritmed Inc. 1200 55th Ave., Lachine, QC H8T 3J8/295 Firetower Road, Tonawanda, NY 14150
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Devices)·Z-0699-2017·2016-12-14

    Tornier Recalls Aequalis Fx2 Shoulder Implant Parts Due to Dislocation Reports

    Tornier is recalling Aequalis Fx2 implant parts and instrument trays due to reports of poly insert and stem dislocations.

    Product
    Aequalis Fx2 implant parts and instrument trays. Insert component : Part Numbers DWK204B-DWK206B, DWK224B-DWK226B, DWK230B-DWK23B, DWK244B-DWK246B, DWK250B-DWK252B, DWK264B-DWK266B, DWK270B-DWK272B. Stem Component: Part Number: DWK111B-DWK115B, DWK121B-DWK126B, DWK131B-DW
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0660-2017·2016-12-07

    Elekta Monaco RTP System Recalled for Incorrect Dose Calculation

    Elekta is recalling 671 Monaco RTP Systems because the reset function may calculate an incorrect dose for external beam radiation therapy plans.

    Product
    Monaco RTP System; Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
    Category
    Medical Device
    Distribution
    26 states
  • SevereFDA (Devices)·Z-0653-2017·2016-11-30

    AtriCure Recalls COBRA Fusion Ablation Systems Due to Component Separation Risk

    AtriCure is recalling COBRA Fusion Ablation Systems because a part may separate and remain in the body, potentially causing permanent impairment or damage.

    Product
    COBRA Fusion 50 Ablation System, COBRA Fusion 150 Ablation System, and COBRA Fusion Magnetic Retriever System. Model Numbers: 700-001, 700-001S, 700-001MI, 700-002, and 700-003. Intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy when con
    Category
    Medical Device
    Distribution
    37 states
  • SevereFDA (Devices)·Z-0487-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

    ICU Medical is recalling 205 SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    Cath Lab Kit For Elkhart Hosp., Item No. 46078-17 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0307-2017·2016-11-16

    FDA Recalls Pipeline Embolization Devices Due to Coating Delamination

    Micro Therapeutics Inc is recalling Pipeline Embolization Devices because PTFE coating may delaminate and enter the bloodstream.

    Product
    Pipeline Embolization Device (Pipeline Classic) The device is indicated for the endovascular treatment of adults (22 year of age or older) with large or giant widenecked intracranial aneurysms (lAs) in the internal carotid artery from the petrous to the superior hypophyseal sege
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0308-2017·2016-11-16

    Ev3 Neurovascular Alligator Retrieval Device Recalled for Coating Defect

    Micro Therapeutics Inc. is recalling 3,337 Alligator Retrieval Devices because the PTFE coating may delaminate and detach, potentially entering the bloodstream.

    Product
    Alligator Retrieval Device The device is intended for use in the peripheral and neurovasculature for foreign body removal. Catalog No. FA-88810-20V04 FA-88810-20V06 FA-88810-30V04 FA-88810-30V06 FA-88810-40V04 FA-88810-40V06 FA-88810-50V04 FA-88810-50V06
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0310-2017·2016-11-16

    Ev3 Neurovascular Recalls X-Celerator Hydrophilic Exchange Guidewires

    Micro Therapeutics Inc is recalling X-Celerator Hydrophilic Exchange Guidewires because PTFE coating delamination may release material into the bloodstream.

    Product
    X-Celerator Hydrophilic Exchange Guidewire Catalog No. 103-0601-300 103-0601-350V10 103-0602-350V06 103-0601-300V01 103-0602-300 103-0602-350V09 103-0601-300V02 103-0602-300V01 103-0602-350V10 103-0601-300V03 103-0602-300V02 103-0601-300V06 103-0602-300v06 103-06
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0373-2017·2016-11-16

    Siemens SOMATOM Definition AS CT Systems Recalled for Injury Risk

    Siemens Medical Solutions is recalling 57 SOMATOM Definition AS CT systems due to a hardware issue that may expose users to rotating or electrical parts.

    Product
    SOMATOM Definition AS system, x-ray, tomography, computed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0378-2017·2016-11-16

    Stryker Recalls LFIT Anatomic V40 Femoral Heads Due to Taper Lock Failure

    Stryker Howmedica Osteonics is recalling specific lots of LFIT Anatomic V40 Femoral Heads because of reported taper lock failures that caused harm.

    Product
    LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile, 36 mm, REF 6260-9-236; Modular components designed to be locked onto a femoral hip stem trunnion during surgery for total hip replacement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0374-2017·2016-11-16

    Siemens SOMATOM Definition Flash CT Systems Recalled for Injury Risk

    Siemens is recalling 57 SOMATOM Definition Flash CT systems in the US due to a hardware issue that may expose users to rotating or electrical parts.

    Product
    SOMATOM Definition Flash system, x-ray, tomography, computed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0336-2017·2016-11-09

    Stryker Neurovascular Recalls Guider Softip XF Guide Catheters

    Stryker Neurovascular is recalling 1,478 Guider Softip XF guide catheters due to a manufacturing defect that could cause hub leaks.

    Product
    Guider Softip XF; GUIDER/MP XF/6FR/90CM, Model number: H965100460. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0349-2017·2016-11-09

    Battle Creek Thermophore Deep-Heat Therapy Devices Recalled for Fire Risk

    Battle Creek Equipment Co. is recalling Thermophore Classic and Plus deep-heat therapy devices because the power cord can spark, causing smoke, fire, and burns.

    Product
    Model 055: Thermophore Classic, Professional Quality, Deep-Heat Therapy, Model 055 Large 14' x 27", Model 056: Thermophore Classic, Professional Quality Deep-Heat Therapy, Model 056 Medium 14" x 14", Model 077: Thermophore Classic Professional Quality Deep-Heat Therapy, Mo
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0357-2017·2016-11-09

    Unomedical AC TenderLink Insulin Infusion Tubing Recalled for Detachment Risk

    Unomedical As is recalling AC TenderLink insulin infusion tubing sets due to a risk of tubing detachment. The voluntary recall affects 653,280 units distributed in the US and internationally.

    Product
    AC TenderLink 13/30 10 pcs; AC TenderLink I 13/60 10 pcs; AC TenderLink I 13/80 10 pcs; AC TenderLink I 17/110 10 pcs; AC TenderLink I 17/30 10 pcs; AC TenderLink I 17/60 10 pcs; AC TenderLink I 17/80 10 pcs; AC TenderLink I 13/110 10 pcs The products are used in combination wit
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0326-2017·2016-11-09

    Hill-Rom Recalls Ceiling Brackets Due to Potential Fall Hazard

    Hill-Rom is recalling 188 ceiling brackets with a larger center hole that could cause the system to fall if the safe working load is exceeded.

    Product
    Product Number 3102071 Ceiling Bracket, Arch 71 White with use on ceiling installed rail systems: Multirall 200, Likorall 200, 242, 243, 250, and LikoGuard L and XL.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0325-2017·2016-11-09

    FDA Recalls Encore Medical Empowr PS Knee System Box Cut Guides

    Encore Medical is recalling 436 units of the Empowr PS Knee System Box Cut Guide because the design can cause femoral chipping during surgery.

    Product
    Empowr PS Knee System Box Cut Guide; Used to make the housing resection for the post of the posterior stabilized implant.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0337-2017·2016-11-09

    Stryker Recalls Guider Softip XF Guide Catheters Due to Hub Leaks

    Stryker Neurovascular is recalling 1,478 Guider Softip XF guide catheters worldwide due to a manufacturing defect that may cause hub leaks.

    Product
    Guider Softip XF; GUIDER/ST XF/8FR/90CM, Model number: H965100520. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states
  • CriticalFDA (Devices)·Z-0116-2017·2016-11-02

    St Jude Medical Recalls Implantable Defibrillators Due to Battery Defect

    St Jude Medical is recalling specific implantable defibrillators because a lithium cluster in the battery can cause a short circuit and premature depletion.

    Product
    Unify, Model No. CD3231-40, CD3231-40Q. Unify Quadra, Model No. CD3249-40, CD3249-40Q. Unify Assura, Model No. CD3257-40, CD3357-40C, CD3357-40Q. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pac
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0115-2017·2016-11-02

    St Jude Medical Recalls Implantable Cardiac Defibrillators Due to Battery Defect

    St Jude Medical is recalling specific implantable cardiac defibrillators and cardiac resynchronization therapy defibrillators because a lithium cluster in the battery can cause a short circuit and premature battery depletion.

    Product
    Fortify VR, Model No. CD1231-40, CD1231-40Q. Fortify ST VR, Model No. CD1241-40, CD1241-40Q. Fortify Assura VR, Model No. CD1257-40, CD1257-40Q, CD1357-40C. Fortify Assura ST VR, Model No. CD1263-40, CD1263-40Q, CD1363-40, CD1363-40Q. Fortify DR, Model No. CD2231-40, CD2231-4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0117-2017·2016-11-02

    St Jude Medical Recalls ICD and CRT-D Devices for Battery Short Circuit

    St Jude Medical is recalling implantable cardiac defibrillators and cardiac resynchronization therapy defibrillators due to a battery defect that can cause premature depletion.

    Product
    Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and vent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0109-2017·2016-11-02

    Roche Recalls cobas p 312 Pre-Analytical System Calculator Modules

    Roche is recalling 9,014 cobas p 312 Pre-Analytical System calculator/data processing modules due to four reported injuries caused by a sharp edge on the sample rack tray.

    Product
    cobas p 312 Pre-Analytical System calculator/data processing module, for clinical use Product Usage: The cobas p471 system is an automatic centrifuge module for centrifuging primary sample tubes, which will then be transported to the output module.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0101-2017·2016-11-02

    Roche Recalls cobas p 701 Post-Analytical Units Due to Sharp Edges

    Roche is recalling 9,014 cobas p 701 Post-Analytical Units because a sharp edge on the sample rack tray caused four reported injuries.

    Product
    cobas p 701 Post-Analytical Unit calculator/data processing module, for clinical use Product Usage: The URISYS 2400 Analyzer is a fully automated urinalysis system intended for in vitro qualitative or semi-quantitative determination of urine analytes, including pH, leukocyte
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0102-2017·2016-11-02

    Roche Recalls cobas p 501 Post-Analytical Units Due to Sharp Edges

    Roche is recalling 9,014 cobas p 501 Post-Analytical Units because a sharp edge on the sample rack tray caused four reported injuries.

    Product
    cobas p 501 Post-Analytical Unit calculator/data processing module, for clinical use Product Usage: The MODULAR PRE-ANALYTICS system is a fully automated system for sample pre-processing, including centrifuging, aliquoting, and barcode labeling, prior to analysis by MODULAR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0108-2017·2016-11-02

    Roche Recalls cobas p 471 Centrifuge Units Due to Sharp Edge Injury Risk

    Roche is recalling 9,014 cobas p 471 centrifuge units because a sharp edge on the sample rack tray caused four reported injuries.

    Product
    cobas p 471 centrifuge unit calculator/data processing module, for clinical use Product Usage: The cobas p312 pre-analytical system is a computer controlled stand-alone system for sorting and decapping sample tubes. As an option, the system works with an online connection.
    Category
    Medical Device
    Distribution
    Distributed nationwide