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.

29451–29475 of 50499

  • HighFDA (Devices)·Z-1259-2018·2018-04-04

    Encore Medical Recalls Altivate Anatomic Pegged Glenoid Trial Instruments

    Encore Medical is recalling 92 units of Altivate Anatomic Pegged Glenoid Trials because the peg base design is larger on the trials than on the implants.

    Product
    Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 50mm, REF 804-07-500 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1233-2018·2018-04-04

    Zimmer Biomet Recalls ACE Trochanteric Nail System Screws

    Zimmer Biomet is recalling ACE Trochanteric Nail System screws because a device performance review failed clinical analysis for survivorship.

    Product
    ACE Trochanteric Nail System ATN AR SCREW 60MM STERILE ATN AR SCREW 65MM STERILE ATN AR SCREW 70MM STERILE ATN AR SCREW 75MM STERILE ATN AR SCREW 80MM STERILE ATN AR SCREW 85MM STERILE ATN AR SCREW 90MM STERILE ATN AR SCREW 95MM STERILE ATN AR SCREW 100MM STERILE…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0987-2018·2018-04-04

    Marsee Baking Variety Pack Cookies Recalled for Undeclared Coconut Allergen

    Pinks Bakery Seattle is recalling Marsee Baking brand Variety Pack cookies because coconut is listed in ingredients but not declared in the allergen statement.

    Product
    Variety Pack, Marsee Baking brand, eight 3.2oz cookies individually wrapped in plastic (Grab and Go) or unwrapped and placed in a paperboard box (Fresh Case). Box contains two Hippie Cookies, and 6 other cookies. Hippie Cookies product labeled in part…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1214-2018·2018-04-04

    Konica Minolta Recalls Sonimage HS1 Ultrasound Kit AC Adapters

    Konica Minolta is recalling 30 Sonimage HS1 Ultrasound Kit AC adapters due to a risk of circuit board breakage and smoke emission.

    Product
    Sonimage HS1 Ultrasound Kit AC adapter, Product Number: 1. A9RP, UDI: 04560141945463; 2. AAEU, UDI: 04560141946385; 3. A9RR, UDI: 04560141945470
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-1266-2018·2018-04-04

    Deerfield Imaging Recalls IMRIS ORT300 Operating Room Tables Due to Drift Risk

    Deerfield Imaging is recalling 13 IMRIS ORT300 operating room tables because they may drift during use, potentially causing unintended movement.

    Product
    IMRIS ORT300, Removable Operating Room Table, Part Numbers: (a) 114093-000 (b) 114093-600
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1267-2018·2018-04-04

    Medica EasyCAL HbA1c Calibrator Recalled for Potential Result Deviations

    Medica Corporation is recalling EasyCAL HbA1c Calibrator kits because patient results may deviate up to 20 percent.

    Product
    EasyCAL HbA1c Calibrator; REF 10658 Kit is packaged in a paper box containing 4 vials of 0.25ml of calibrant, one for each calibration level, and an insert sheet.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1265-2018·2018-04-04

    Deerfield Imaging Recalls IMRIS T2X Operating Room Tables

    Deerfield Imaging is recalling 14 IMRIS T2X Operating Room Tables because they may drift during use, potentially causing unintended movement.

    Product
    IMRIS T2X Table, Part Numbers: (a) 108000-000 (b) 108000-600 (c) 109682-000 (d) 109682-600
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0965-2018·2018-04-04

    Griffith Foods Recalls Premix Roasted Chicken Due to Salmonella Risk

    Griffith Foods is voluntarily recalling Premix Roasted Chicken because a supplier recalled Autolyzed Yeast Powder for Salmonella.

    Product
    Product Name Lot Number or ID Premix Roasted Chicken 1258969 660025
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0961-2018·2018-04-04

    Griffith Foods Pan Roast Brown Gravy Mix Recalled for Salmonella Risk

    Griffith Foods is voluntarily recalling Pan Roast Brown Gravy Mix because a supplier recalled Autolyzed Yeast Powder due to Salmonella.

    Product
    Product Name Lot Number or ID Pan Roast Brown Gravy Mix 659281, 659282, 659283, 659284, 659285, 659286 Pan Roast Brown Gravy Mix 661090, 661089, 661091
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1246-2018·2018-04-04

    Stryker InterPulse Handpieces Recalled for Sterility Assurance Issues

    Stryker is recalling InterPulse Handpieces because bioburden levels were found to be higher than internal acceptable rates, indicating a lack of sterility assurance.

    Product
    1. InterPulse Handpiece with coaxial bone cleaning tip, Product Number: 0210-110-100, UDI: (01)4546540861641; 2. InterPulse Handpiece with Coaxial High Flow Tip, Product Number: 0210-114-100, UDI: (01)4546540861764; 3. InterPulse Handpiece with Retractable Coaxial Fan Spray Tip…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1240-2018·2018-04-04

    Zimmer Biomet Recalls Persona Partial Knee Spacer Blocks

    Zimmer Biomet is recalling Persona Partial Knee Spacer Blocks because they may feel tight during trialing or appear loose in extension.

    Product
    Persona Partial Knee Spacer Blocks To assist in partial knee arthroplasty surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1256-2018·2018-04-04

    Encore Medical Recalls Altivate Anatomic Pegged Glenoid Trial Instruments

    Encore Medical is recalling 92 units of Altivate Anatomic Pegged Glenoid Trials because the peg base design is larger on the trials than on the implants.

    Product
    Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 38mm, REF 804-07-380 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1184-2018·2018-04-04

    Siemens Dimension Vista LOCI 8 Calibrator Recalled for Calibration Failures

    Siemens Healthcare Diagnostics is recalling the Dimension Vista LOCI 8 Calibrator due to increased failed calibration events and negative bias in Estradiol assays.

    Product
    Dimension Vista System LOCI 8 CALIBRATOR The LOCI 8 Calibrator is an in vitro diagnostic product for the calibration of follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin (PRL), and estradiol (E2) methods on the Dimension Vista System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1170-2018·2018-04-04

    St. Jude Medical Recalls Proclaim DRG Implantable Pulse Generators

    St. Jude Medical is recalling 17 Proclaim DRG Implantable Pulse Generators due to error messages during routine checks and transient overstimulation causing patient discomfort.

    Product
    Proclaim DRG Implantable Pulse Generator, Model Number 3664
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1176-2018·2018-04-04

    ConMed Mini Infant Radiotranslucent Electrodes Recalled for Adhesive Conductivity Issues

    ConMed is recalling 18,720 Mini Infant Radiotranslucent Electrodes because adhesive on contact wires may impede conductivity and cause failure.

    Product
    MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, REF/Catalog Number 2602H Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1218-2018·2018-04-04

    Deerfield Imaging Recalls IMRIS ORT300 Operating Room Tables

    Deerfield Imaging is recalling 13 IMRIS ORT300 operating room tables because their rotational locking mechanisms may fail to operate, preventing the table from changing between locked and unlocked states.

    Product
    IMRIS ORT300 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic examinations or surgical procedures to support and position a patient.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1263-2018·2018-04-04

    Deerfield Imaging Recalls IMRIS ORT100 Operating Room Tables

    Deerfield Imaging is recalling 26 IMRIS ORT100 operating room tables because they may drift during use, potentially causing unintended movement.

    Product
    IMRIS ORT100 Table, Part Numbers: (a) 110470-000 (b) 110470-600
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1264-2018·2018-04-04

    Deerfield Imaging Recalls IMRIS ORT200 Operating Room Tables for Drift Risk

    Deerfield Imaging is recalling 17 IMRIS ORT200 operating room tables because they may drift during use, potentially causing unintended movement.

    Product
    IMRIS ORT200, Removable Operating Room Table, Part Numbers: (a) 113821-000 (b) 113821-600 (c) 114148-000 (d) 114148-600
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0976-2018·2018-04-04

    IDLife Chocolate and Almond Snack Bars Recalled for Undeclared Peanuts

    IDLife, LLC is recalling IDLife Snack Bar Chocolate and Almond because the product contains almonds but does not declare the presence of peanuts.

    Product
    IDLife Snack Bar Chocolate and Almond (SKU 16-0011) Organic, non-GMO and gluten-free snack bar. Individually wrapped bars, packaged 10 to a box
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1188-2018·2018-04-04

    Cook Inc. Recalls IVF Embryo Transfer Sets Due to Quality Testing Gaps

    Cook Inc. is recalling specific lots of IVF embryo transfer sets and catheters because they were distributed without completed quality testing, posing a risk of nonviable gametes or embryos.

    Product
    1. SMS Embryo Transfer Set, Catalog Number: K-J-SMS-571800, Global Product Number: G19182; 2. Guardia" Access Nano Embryo Transfer Catheter, Catalog Number: K-JETS-551910-L, Global Product Number: G24215; 3. Sydney IVF¿ Embryo Transfer Set, Product Number: K-JETS-7019-SIVF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1268-2018·2018-04-04

    Roche cobas e 601 Immunoassay Analyzer Recalled for Questionable Results

    Roche Diagnostics is recalling cobas e 601 Immunoassay Analyzers because complaints were received regarding questionable results caused by the use of 13 sample tubes without tube adapters.

    Product
    c6000, Chemistry (Photometric, Discrete), for clinical use. - cobas e 601 module: Immunoassay Analyzer, Catalog Numbers: 04745922001, 05036348001, 05860652001, 04745922692, 05036348001 & 05036348692
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1235-2018·2018-04-04

    Zimmer Biomet Recalls ACE Trochanteric Nail System After Failed Performance Review

    Zimmer Biomet is recalling the ACE Trochanteric Nail System because a Device Performance Review failed clinical analysis for survivorship.

    Product
    ACE Trochanteric Nail System STER L H TROC NAIL 320X9X125 STER L H TROC NAIL 340X9X125 STER L H TROC NAIL 360X9X125 STER L H TROC NAIL 380X9X125 STER L H TROC NAIL 400X9X125 STER L H TROC NAIL 420X9X125 STER L H TROC NAIL 440X9X125 STER L H TROC NAIL 460X9X125 STER L H…
    Category
    Medical Device
    Distribution
    Distributed nationwide