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.

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

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Minimum severity

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

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26601–26625 of 27686

  • SevereFDA (Devices)·Z-1117-2013·2013-04-24

    Hospira GemStar Infusion Pump Recall for Potential Over-Infusion

    Hospira is recalling GemStar infusion pumps because the motor may rotate backwards during low-rate infusions, causing the device to deliver too much medication.

    Product
    The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1123-2013·2013-04-24

    Advanced Sterilization Products Recalls EVOTECH Endoscope Cleaner Systems

    Advanced Sterilization Products is recalling 273 EVOTECH Endoscope Cleaner & Reprocessor Systems because they did not receive sufficient High Potential (HIPOT) DC voltage testing.

    Product
    EVOTECH Endoscope Cleaner & Reprocessor System, P/N 50004 Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1143-2013·2013-04-24

    Elana Catheter Sizer 2.0 Recalled for Unapproved Distribution

    Elana, Inc. is recalling three Elana Catheter Sizer 2.0 devices because they were distributed in interstate commerce without FDA approval.

    Product
    Elana Catheter Sizer 2.0*** The Elana Catheter Sizer 2.0 is designed to aid the surgeon to assess the bypass graft of the ELANA technique.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1137-2013·2013-04-24

    GE Healthcare AW Server Recalled for Patient Data Display Error

    GE Healthcare is recalling AW Server software due to a defect where patient data from one individual may be displayed in the Results Viewer for a different patient.

    Product
    GE Healthcare, AW Server. Product Usage: . AW Server is a medical software system that allows multiple users to remotely access AW applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1131-2013·2013-04-24

    Heritage Labs Path Study Extra Supplies Kit Recalled for Contamination

    Heritage Labs is recalling 25 Path Study Extra Supplies Kits because they contain blood collection tubes with a Lithium Heparin contaminant that could cause erroneous lab results.

    Product
    Heritage Labs Path Study Extra Supplies Kit, Product # A 2376, kit contains 3 zippered plastic bags which hold support supplies for health care providers when treating patients. Bag #3 contains 5 different blood collection tubes (5 each) and 2 different gauge needles--all for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1147-2013·2013-04-24

    Transonic AV Loop Kit Recalled for Blood Leakage Complaints

    Transonic Systems Inc. is recalling HCS3011 and HCS3021 AV Loop Kits due to complaints of blood leakage. The kits are used for cardiovascular status assessment.

    Product
    HCS3011 AV Loop Kit For use with Transonic CO status System Only, -HCS3021 AV Loop Kit For use with Transonic CO status System Only. Product Usage: is indicated for use in patients greater than or equal to 2 years old with arterial and venous lines in the diagnostic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1151-2013·2013-04-24

    Siemens Vista Drug 4 Calibrator Recalled for Low Bias

    Siemens is recalling Vista Drug 4 Calibrators because they cause low digoxin test results, potentially affecting patient care.

    Product
    Siemens Dimension Vista(R) System Vista Drug 4 Calibrator. The device is used as an in vitro diagnostic product.
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-1133-2013·2013-04-24

    GE Healthcare Recalls Muse v7 Cardiology System Due to Medication Display Error

    GE Healthcare is recalling Muse v7 cardiology systems because they may display incorrect medications, potentially leading to incorrect patient treatment.

    Product
    GE Healthcare Muse v7 cardiology information system. Model number 2026443-001: MUSE 7.0 app cd, Model Number 2026443-015: MUSE 7.0.2 app cd, Model number 2026443-017: MUSE 7.1 app cd, Model number 2026443-029:MUSE 7.1.1 A app cd, and Model Number 2026443-031: MUSE 7.1.1 app cd.…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1105-2013·2013-04-24

    Siemens syngo WorkFlow SLR Recall for Patient Data Display Error

    Siemens Medical Solutions is recalling syngo WorkFlow SLR software due to a defect that may display the wrong patient's documents in signed reports.

    Product
    Siemens syngo WorkFlow SLR, Radiological Information System, Version VA31A SP1/SP2/SP3 The information system syngo(R) Workflow SLR is a digital radiology information system (RIS) with integrated modules for patient administration, examination, reporting, statistics and…
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Devices)·Z-1114-2013·2013-04-24

    Roche Recalls CoaguChek XS Pro Meters Due to Barcode Reading Errors

    Roche is recalling CoaguChek XS Pro meters and Accu-Chek Inform II barcode scanners because they may incorrectly decode patient identification barcodes.

    Product
    CoaguChek XS Pro meters (catalog number 05530199160)bar code scanner. Used with the CoagCHEK XS Pro Meters to quantitatively determines prothrombin time ("PT").
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1145-2013·2013-04-24

    ACIST Angiographic Injection System Recall for Air Ingress

    Acist Medical Systems is recalling 6,640 units of BT2000 Automated Manifold Kits due to air ingress into the manifold body.

    Product
    ACIST Medical Systems Inc. The ACIST Angiographic Injection System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1142-2013·2013-04-24

    GE Healthcare Recalls Innova IQ Systems Due to Missing Safety Label

    GE Healthcare is recalling 48 Innova IQ systems manufactured between March 2010 and July 2011 because a safety label is missing from the gantry pivot section.

    Product
    GE Healthcare, Innova 2100IQ, Innova 3100IQ, Innova 4100IQ, Cardiovascular and Interventional Imaging System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1149-2013·2013-04-24

    Maquet Cardiohelp Support System Recalled for Unexpected Shutdowns

    Maquet is recalling 154 Cardiohelp Support Systems because the touch screen display may shut down unexpectedly and restart automatically.

    Product
    MAQUET CARDIOHELP Support System: CARDIOHELP-I Software (up to version 3.3.0.0) Product Usage: The Cardiohelp System is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1134-2013·2013-04-24

    Edwards Lifesciences Crimpers Recalled for Potential Sterile Barrier Pouch Holes

    Edwards Lifesciences is recalling 5,472 units of Model 9100CR23 Crimpers because holes in the sterile barrier pouch may compromise sterility.

    Product
    Edwards Lifesciences Crimpers, Model 9100CR23. The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1111-2013·2013-04-24

    Edwards Lifesciences Recalls Duraflo Coated Femoral Cannula Due to Sealing Defect

    Edwards Lifesciences is recalling 379 units of Duraflo coated Femoral Cannula because two unsealed pouches were found at a distribution location, posing a sterility risk.

    Product
    Edwards Lifesciences Duraflo coated Femoral Cannula. Product Usage: The cannulae are intended for use in situations which require rapid femoral venous and arterial access for short-term (< 6 hours) cardiopulmonary bypass. Vessel access (venous or arterial) is left to the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1112-2013·2013-04-24

    Carefusion Recalls Alaris PC Unit 8015 Due to Bolus Programming Risk

    Carefusion is recalling 4,090 Alaris PC unit model 8015 devices with software version 9.12 due to potential data loss risks during bolus programming.

    Product
    Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1113-2013·2013-04-24

    Roche Recalls Accu-Chek Inform II Barcode Scanners Due to Decoding Errors

    Roche Diagnostics is recalling Accu-Chek Inform II and CoaguChek XS Pro barcode scanners because they may intermittently misread patient identification barcodes.

    Product
    ACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner. Used with the ACCU-CHEK Inform II System to quantitatively measure glucose (sugar).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1135-2013·2013-04-24

    Edwards Lifesciences Crimpers Recalled for Potential Sterile Barrier Pouch Holes

    Edwards Lifesciences is recalling 6,117 units of Model 9100CR26 Crimpers because holes in the sterile barrier pouch may compromise sterility.

    Product
    Edwards Lifesciences Crimpers, Model 9100CR26. The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1136-2013·2013-04-24

    EndoGastric Solutions Recalls EsophyX2 Plus Devices Due to Lack of Validation

    EndoGastric Solutions is recalling 190 EsophyX2 Plus devices used to treat GERD because they were not validated under actual or simulated use conditions before distribution.

    Product
    EndoGastric Solutions EsophyX2 Plus Device with Serosa Fastener and Accessories Part number C02033-01. Label reads in part "EsophyX2 2-LINK Device Qty: (1) Fastener Delivery System ***" Designed for the treatment of Gastroesophageal Reflux Disease (GERD), with erosive and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1102-2013·2013-04-24

    Philips IntelliSpace Portal Software Recall for URL PACS Integration Issue

    Philips is recalling IntelliSpace Portal software version 4.0.2 due to a display error when using URL PACS integration. The issue causes the Review monitor to display incorrect patient studies.

    Product
    Intellispace Portal (ISP) Philips Medical Systems (Cleveland), Inc., IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1124-2013·2013-04-24

    Biomet Oxford Uni Knee System Toffee Hammer Recalled for Weld Cracking

    Biomet U.K., Ltd. is recalling 430 Oxford Uni Knee System Toffee Hammers because excessive use may cause the head to detach from the handle.

    Product
    REF 32-422760 Oxford Uni Knee System,Toffee Hammer, non-sterile, found in REF 32-422763 Oxford Mlcroplasty Knee System Tibial instrument Tray small surgical hammer supplied with the Oxford Partial Knee Microplasty Instrument set, used for impacting implants.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1051-2013·2013-04-17

    GE Healthcare Recalls Giraffe OmniBed and Incubator Units for Display Errors

    GE Healthcare is recalling 679 Giraffe OmniBed and Incubator units because display boards may randomly overwrite stored information and set points upon power up or recovery from a power failure.

    Product
    Giraffe OmniBed¿ and Giraffe Incubator p/n 6600-0723-700 (rev A and B) labeled in part: ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 U.S.A. www.gehealthcare.com***. GE Healthcare Giraffe Omnibed is a combination of an infant incubator and an infant warmer.
    Category
    Medical Device
    Distribution
    29 states
  • SevereFDA (Devices)·Z-1063-2013·2013-04-17

    FDA Recalls Covidien Endo GIA AutoSuture Universal Loading Units

    FDA is recalling 6,751 units of the Covidien Endo GIA AutoSuture Universal Loading Unit because a defect may cause difficulty firing the device, potentially requiring medical intervention.

    Product
    Covidien Endo GIA AutoSuture Universal Loading Unit, 30mm-2.0mm Product Code: 030450 Applications in abdominal, gynecologic, pediatric anti thoracic surgery for resection, transection and creation of anastomosis.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1066-2013·2013-04-17

    Stelkast Cross-over Acetabular Shell and Liner Hip System Recalled

    Stelkast Co is recalling 254 units of the Cross-over Acetabular Shell and Liner Hip System due to difficulty engaging and securing the liner.

    Product
    Stelkast Cross-over Acetabular Shell and Liner Hip System, Part Numbers SC3458-52, SC3474-52, SC3459-52, and SC3460-52. Intended for use in reconstruction of the articulating surface of the acetabular portion of the hip.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1081-2013·2013-04-17

    Siemens ACUSON SC2000 Ultrasound System Recalled for Temperature Display Error

    Siemens is recalling ACUSON SC2000 ultrasound systems with specific hardware due to a temperature display error that may underestimate transducer heat, posing a burn risk.

    Product
    Siemens brand ACUSON SC2000 Ultrasound System, Model 10433816, hardware that contains version 4 of the MPI board 10434200; The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult…
    Category
    Medical Device
    Distribution
    0 states