The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

43701–43725 of 50511

  • 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 (Food)·F-1328-2013·2013-04-24

    Fresh & Easy Organic Apple Juice Recalled for Potential Patulin Contamination

    Fresh & Easy is recalling Organic 100% Apple Juice from concentrate because it may be contaminated with patulin. The product was distributed in California, Arizona, and Nevada.

    Product
    Fresh & Easy Organic 100% Apple Juice from concentrate, 64 oz, 8 units/case. UPC/Barcode: 50513790021007 ORIN: 100012615 SPORIN: 100012623
    Category
    Food
    Distribution
    3 states
  • 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 (Food)·F-1320-2013·2013-04-24

    Zumbro River Brand Recalls Ideal Protein BBQ Ridges Due to Wire Contamination

    Zumbro River Brand is recalling Ideal Protein BBQ Ridges because a flour ingredient may contain fine wire pieces.

    Product
    Ideal Protein, BBQ Ridges, 7 packets Net WT 1.4 oz (40 g) each. Total net weight 9.9 oz (280 g). Distributed by Laboratories C.O.P Inc., 60 Jean-Proulx St Gatieau QC Canada J8Z 1W1
    Category
    Food
    Distribution
    0 states
  • HighCPSC·13176·2013-04-24

    Reed and Barton Recalls Gingham Bunny Baby Forks and Spoons

    Reed and Barton is recalling Gingham Bunny baby flatware because the pink coloring on the bunny ears can come off, posing choking and ingestion hazards.

    Product
    Gingham Bunny forks and spoons for babies
    Category
    Consumer Product
    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
  • HighNHTSA·13V160000·2013-04-24

    Terex Recalls 1998-2005 Aerial Devices Due to Fatigue Cracks

    Terex is recalling 1998-2005 OM Aerial Devices because fatigue cracks in the leveling arm may cause failure, risking injury to operators.

    Product
    TEREX — TEREX AERIAL DEVICES
    Category
    Vehicle
    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
  • HighNHTSA·13E020000·2013-04-23

    C. E. White Recalls School Bus Flip Seats for Pinch Hazard

    C. E. White is recalling specific school bus flip seats installed between 2005 and 2013 because the lower frame gap can pinch the toes or feet of passengers in rearward seats.

    Product
    SEATS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V155000·2013-04-23

    Keystone Recalls 2013-2014 Recreational Trailers Due to Awning Motor Defect

    Keystone RV Company is recalling 2013-2014 recreational trailers because a damaged awning motor may cause the awning to unfurl unexpectedly, increasing the risk of injury or a crash.

    Product
    KEYSTONE — KEYSTONE RAPTOR, SUMMERLAND, RESIDENCE, SPRINGDALE
    Category
    Vehicle
    Distribution
    Distributed nationwide