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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3851–3875 of 5111

  • 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-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-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
  • 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-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
  • 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-0105-2017·2016-11-02

    Roche Recalls cobas 8000 Sorting System Modules Due to Injury Reports

    Roche is recalling 9,014 cobas 8000 Sorting System calculator/data processing modules after four reports of injury caused by a sharp edge on the sample rack tray.

    Product
    RSD 800 Sorting System calculator/data processing module, for clinical use Product Usage: The cobas 8000 Modular Analyze Series is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in bo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0098-2017·2016-11-02

    Roche Modular Pre Analytics EVO/Plus Recall for Sharp Edge Injury Risk

    Roche is recalling Modular Pre Analytics EVO/Plus systems because a sharp edge on the sample rack tray caused four reported injuries.

    Product
    Modular Pre Analytics ( EVO/Plus) Product Usage: The RSD 800A is a computer-controlled stand-online system for decapping, aliquoting and sorting of primary tubes and for producing and sorting bar coded secondary tubes.. The system operates with an online connection to the hos
    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-0107-2017·2016-11-02

    Roche Recalls cobas p 512 Pre-Analytical Instrument Due to Sharp Edge Injury Reports

    Roche is recalling 9,014 cobas p 512 Pre-Analytical Instruments after four reports of injury caused by a sharp edge on the sample rack tray.

    Product
    cobas p 512 Pre-Analytical Instrument calculator/data processing module, for clinical use Product Usage: The cobas 6800/8800 systems support an automated and integrated workflow to run Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) to be applied in diagnost
    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-0110-2017·2016-11-02

    Roche Recalls cobas 6800/8800 Systems Due to Sharp Edge Injury Risk

    Roche is recalling 9,014 cobas 6800/8800 systems because a sharp edge on the sample rack tray caused four reported injuries.

    Product
    cobas 6800/8800 system Hepatitis Viral B DNA Detection Product Usage: The cobas p512 pre-analytical system is a computer controlled fully automatic system for sorting of open and closed barcoded and centrifuged sample tubes. It includes modules for registration and decapping
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0097-2017·2016-11-02

    Roche Recalls cobas 8000 Analyzers Due to Sharp Edge Injury Reports

    Roche is recalling cobas 8000 Modular Analyzers and e602 Immunoassay Analyzers after four reports of injury caused by a sharp edge on the sample rack tray.

    Product
    cobas 8000 Modular Analyzer Series c8000, Chemistry (Photometric, Discrete) for clinical use Modular e602: Immunoassay Analyzer Product Usage: The VS II system is a stand-alone, computer-controlled instrument designed to aliquot patient sample from a primary tube to a barcod
    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-0104-2017·2016-11-02

    Roche RSD 800A Aliquoting System Recalled Due to Sharp Edge Injury Reports

    Roche is recalling 9,014 RSD 800A Aliquoting System calculator/data processing modules because four reports of injury were received from the sharp edge of the sample rack tray.

    Product
    RSD 800A Aliquoting System calculator/data processing module, for clinical use Product Usage: The Roche/Hitachi MODULAR Analytics System is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quan
    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
  • SevereFDA (Devices)·Z-0095-2017·2016-11-02

    Roche Recalls cobas e411 Immunoassay Analyzers Due to Sharp Edge Injury Risk

    Roche is recalling 9,014 cobas e411 Immunoassay Analyzers because the sharp edge of the sample rack tray center guide rail caused four reported injuries.

    Product
    cobas e411 Immunoassay Analyzer e411: Immunoassay Analyzer Product Usage: The cobas p501/p701 instrument stores primary and secondary sample tubes. The tubes are stored in a controlled, refrigerated sample store. Automatic retrieval for add-on testing is possible at any time
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0100-2017·2016-11-02

    Roche COBAS INTEGRA 800 Analyzer Recalled Due to Sharp Edge Injury Reports

    Roche is recalling COBAS INTEGRA 800 analyzers after four reports of injury caused by the sharp edge of the sample rack tray.

    Product
    Roche COBAS INTEGRA 800 /800 CTS Analyzer Analyzer, Chemistry (Photometric, Discrete for Clinical use Product Usage: The system cobas p612 is a computer-controlled stand-alone system for aliquoting and sorting of barcoded sample tubes. The system operates with an online conn
    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-0096-2017·2016-11-02

    Roche Recalls cobas 6000 Series Analyzers Due to Sharp Edge Injury Risk

    Roche is recalling cobas 6000 Series analyzers because the sharp edge of the sample rack tray center guide rail caused four reported injuries.

    Product
    cobas 6000 Series system c6000, Chemistry (Photometric, Discrete), for clinical Use. Modular e601: Immunoassay Analyzer Product Usage: The cobas p501/p701 instrument stores primary and secondary sample tubes. The tubes are stored in a controlled, refrigerated sample store. A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0106-2017·2016-11-02

    Roche cobas p 612 Pre-Analytical Instrument Recall for Sharp Edge Injury

    Roche is recalling cobas p 612 Pre-Analytical Instruments because the sharp edge of the sample rack tray center guide rail caused four reported injuries.

    Product
    cobas p 612 Pre-Analytical Instrument calculator/data processing module, for clinical use Product Usage: The cobas 6000 series is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative i
    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-0094-2017·2016-11-02

    Roche Modular Analytics Systems Recalled Due to Sharp Sample Rack Edge

    Roche is recalling Modular Analytics Combination Systems because a sharp edge on the sample rack tray caused four reported injuries. The cleaning procedure has been revised to clarify the process.

    Product
    Roche/Hitachi MODULAR Analytics Combination Systems Modular D/P: Clinical Chemistry Analyzer, Chemistry (Photometric, Discrete) for clinical use. Modular E170: Immunoassay Analyzer Product Usage: The Roche COBAS INTEGRA 800/800 CTS Analyzer is fully automated system for clin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0300-2017·2016-11-02

    Ortho-Clinical Diagnostics Recalls enGen Laboratory Automation System Due to Sample Error

    Ortho-Clinical Diagnostics is recalling the enGen Laboratory Automation System because a software error may cause sample identification to be mismatched with assay results.

    Product
    enGen Laboratory Automation System (Product Code ENGEN) configured with Thermo Scientific Centrifuge Module and TCAutomation Software Version 3.6.1 and Below; IVD. --- Thermo Scientific Centrifuge Module has Product Code 952040-EG 6844097. The VITROS 5,1 FS Chemistry System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0099-2017·2016-11-02

    Roche URISYS 2400 Urine Analyzer Recalled for Sharp Edge Injury Risk

    Roche is recalling URISYS 2400 Urine Analyzers because a sharp edge on the sample rack tray caused four reported injuries.

    Product
    URISYS 2400 Urine Analyzer Automated Urinalysis System Product Usage: The RSD 800 is a computer-controlled stand-alone sorting system for sorting barcoded samples. The system has an online connection to the host.
    Category
    Medical Device
    Distribution
    Distributed nationwide