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.

29476–29500 of 50499

  • HighFDA (Food)·F-0967-2018·2018-04-04

    Griffith Foods Recalls Au Jus Seasoning Due to Salmonella Risk

    Griffith Foods is voluntarily recalling specific lots of Au Jus Seasoning Reduced Sodium because a supplier recalled Autolyzed Yeast Powder for Salmonella.

    Product
    Product Name Lot Number or ID Au Jus Seasoning Reduced Sodium 659868, 660660, 660661, 660662, 660663 Au Jus Seasoning Reduced Sodium 656387, 656388, 659864, 659865, 659866, 659867
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1180-2018·2018-04-04

    BD Vacutainer Blood Collection Tubes Recalled for Residual Blood on Stopper

    Becton Dickinson is recalling 1,976,000 BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection Tubes because increased residual blood was found on the top of the stopper well after venipuncture.

    Product
    BD Vacutainer¿ Barricor" Lithium Heparin Plasma Blood Collection Tubes for Invitro Diagnostic Use, Catalog Numbers: 365043, 365044, 365045 & 365047 Used to collect, separate, process, transport and store venous blood samples for use in chemistry determinations, therapeutic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1232-2018·2018-04-04

    Zimmer Biomet Recalls ACE Trochanteric Nail System Due to Performance Failure

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

    Product
    ACE Trochanteric Nail System STER TROC NAIL 180X13X140 STER TROC NAIL 125 DEG X 13MM STER TROC NAIL 130 DEG X 13MM STER TROC NAIL 135 DEG X 13MM The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0966-2018·2018-04-04

    Griffith Foods Recalls Salt & Vinegar Seasoning Due to Salmonella Risk

    Griffith Foods is voluntarily recalling Salt & Vinegar Seasoning because a supplier recalled Autolyzed Yeast Powder due to Salmonella presence.

    Product
    Product Name Lot Number or ID Salt & Vinegar Seasoning - 50 LB CS 662977
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1229-2018·2018-04-04

    Zimmer Biomet Recalls ACE Trochanteric Nail System Due to Performance Failure

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

    Product
    ACE Trochanteric Nail System TROCH NAIL ST 11X180 125DG STRL TROCH NAIL ST 11X180 130DG STRL TROCH NAIL ST 11X180 135DG STRL The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1254-2018·2018-04-04

    Stryker iVAS System Kits Recalled for Sterility Assurance Issues

    Stryker is recalling 504 iVAS System Kits for spinal orthopedic use because bioburden levels were found to be higher than internal acceptable rates, indicating a lack of sterility assurance.

    Product
    1. 11g/10mm iVAS System Kit, Product Number: 0705-310-000, UDI: (01)7613252505983; 2. 11g/15mm iVAS System Kit, Product Number: 0705-315-000, UDI: (01)7613252505969 for spinal orthopedic use.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1258-2018·2018-04-04

    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 46mm, REF 804-07-460 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-1174-2018·2018-04-04

    ConMed Mini Infant Radiotranslucent Electrodes Recalled for Adhesive Defect

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

    Product
    MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Universal/Anderson Connector, REF/Catalog Number 2602 Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1216-2018·2018-04-04

    Stryker Recalls Thoracic Pedicle Feelers Due to Potential Tip Breakage

    Stryker is voluntarily recalling 28 Thoracic Pedicle Feelers because machine settings caused material degradation, creating a risk that the instrument tip may break.

    Product
    The Stryker Thoracic Pedicle Feeler 6002-350-000 is a smart instrument for remote control of the navigation software and creation of a pathway into the pedicle. The instrument has three types of buttons to remotely control the software: the UP, DOWN and SELECT buttons. The…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1181-2018·2018-04-04

    Ohmeda Medical Recalls Rotating IV Poles Due to Fall Risk

    Ohmeda Medical is recalling 1,179 rotating IV poles because they may fall, posing a risk of injury to patients, bystanders, or operators.

    Product
    Rotating IV Pole Rotating IV Pole falls under the category classified as capital equipment, an optional accessory that may be purchased to facilitate attachment and consolidation of patient equipment to one central patient care area. Devices commonly attached to IV poles…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1257-2018·2018-04-04

    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 42mm, REF 804-07-420 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-1234-2018·2018-04-04

    Zimmer Biomet Recalls ACE Trochanteric Nail System Due to Performance Failure

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

    Product
    ACE Trochanteric Nail System ATN LAG SCREW 60MM STERILE ATN LAG SCREW 65MM STERILE ATN LAG SCREW 70MM STERILE ATN LAG SCREW 75MM STERILE ATN LAG SCREW 80MM STERILE ATN LAG SCREW 85MM STERILE ATN LAG SCREW 90MM STERILE ATN LAG SCREW 95MM STERILE ATN LAG SCREW 100MM…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1222-2018·2018-04-04

    Inova Diagnostics Recalls QUANTA-Lyser 240 EIA Due to Power Supply Defect

    Inova Diagnostics is recalling one QUANTA-Lyser 240 EIA instrument because a defective power supply may cause loss of protective grounding.

    Product
    QUANTA-Lyser 240 EIA, Part #GS0241. The instrument is a fully automated, high-throughput, bench top system designed for clinical use to automate slide and reagent barcode reading, sample dilution and distribution, reagent pipetting and dispensing, slide and plate washing…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0986-2018·2018-04-04

    Marsee Baking Hippie Cookies Recalled for Undeclared Coconut Allergen

    Pinks Bakery Seattle, Inc. is recalling Marsee Baking brand Hippie Cookies because coconut is listed in the ingredients but not declared in the 'Contains' statement. The product was distributed in Oregon and Washington.

    Product
    Hippie Cookie, Marsee Baking brand, six 3.2oz cookies individually wrapped in plastic (Grab and Go) or six unwrapped, bulk packed on baking paper and placed in a paperboard box (Fresh Case). Product labeled in part, "Ingredients:***Coconut***Allergens: Contains Eggs, Tree…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1185-2018·2018-04-04

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

    Cook Inc. is recalling specific lots of Norm-Ject Tuberkulin Syringes used for IVF embryo transfer because they were distributed without completed quality testing.

    Product
    Norm-Ject Tuberkulin Syringe, Catalog Number: K-ATS-1000, Global Product Number: G19871 Product Usage: Used to place in vitro fertilized (IVF) embryos into the uterine cavity. Intended for one-time use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0952-2018·2018-04-04

    Mondelez Recalls Sour Patch Kids Due to Peanut Shell Remnants

    Mondelez Global LLC is recalling 1.9 lb bags of Sour Patch Kids because peanut shell remnants were found in two containers. The product is not labeled as containing peanuts.

    Product
    Sour Patch Kids, 1.9 lb bag
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-1196-2018·2018-04-04

    Zimmer Biomet Recalls AIM Tibial Nails Due to High Revision Rates

    Zimmer Biomet is recalling AIM Tibial Nails because the surgical revision rate exceeded acceptance criteria in a clinical analysis.

    Product
    AIM Tibial Nails intramedullary fixation rod - STERILE; Item numbers: 800508255 NAIL TIB DYN 08X25.5 - STERILE 800508270 NAIL TIB DYN 08X27.0 - STERILE 800508285 NAIL TIB DYN 08X28.5 - STERILE 800508300 NAIL TIB DYN 08X30.0 - STERILE 800508315 NAIL TIB DYN 08X31.5 - STERILE…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1182-2018·2018-04-04

    Madison Polymeric Engineering Recalls First Step Flexible Endoscope Bedside Pre-Clean Kit

    Madison Polymeric Engineering is recalling 285 cases of the First Step Flexible Endoscope Bedside Pre-Clean Kit because affected lots may have exceeded microbial limits.

    Product
    First Step Flexible Endoscope Bedside Pre-Clean Kit, EP-4. Intended for pre-clean of outer surface of flexible scopes and surgical instruments to remove gross contamination prior to manual cleaning and disinfection. Product Labeling: "The multi-tiered enzymatic detergent starts…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1213-2018·2018-04-04

    Konica Minolta Sonimage HS1 Ultrasound Kit AC Adapter Recall

    Konica Minolta is recalling 85 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: A8WA, UDI: 04560141944534
    Category
    Medical Device
    Distribution
    35 states
  • HighCPSC·18135·2018-04-03

    3M Recalls Scotch Thermal Laminators Due to Overheating Burn Hazard

    3M is recalling about 395,000 Scotch thermal laminators because the plastic enclosure can overheat, posing a burn hazard. No injuries have been reported.

    Product
    Scotch™ thermal laminators
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·18133·2018-04-02

    Polaris Recalls RZR XP 1000 Vehicles Due to Exhaust Fire Hazard

    Polaris is recalling about 107,000 RZR XP 1000 vehicles because a cracked exhaust silencer can cause a fire. No injuries have been reported.

    Product
    Model Year 2014-2018 Polaris RZR XP 1000
    Category
    Vehicle
    Distribution
    Distributed nationwide