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.

36851–36875 of 50506

  • HighCPSC·16074·2016-01-14

    Steelcase Recalls Rocky Swivel Chairs Due to Fall Hazard

    Steelcase is recalling about 17,000 Rocky model swivel chairs because screws can detach, posing a fall hazard. One injury was reported.

    Product
    Rocky model swivel chairs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·16721·2016-01-14

    School Specialty Recalls NeoRok Stools Due to Fall Hazard

    School Specialty is expanding a recall of NeoRok stools that can break during use, posing a fall hazard to children.

    Product
    Classroom Select NeoRok Stools
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0592-2016·2016-01-13

    Biomet 3i Protection Cap Kits Recalled for Inadequate Biocompatibility Testing

    Biomet 3i is recalling 30,111 Protection Cap Kits worldwide due to inadequate biocompatibility testing. The devices are used as accessories for dental implants.

    Product
    BIOMET 3i, PROVIDE PROTECTION CAP KITS, Catalog # PAK4140, PAK4155, PAK4240, PAK4255, PAK4340, PAK4355, PAK4440, PAK4455, PAK5140, PAK5155, PAK5240, PAK5255, PAK5340, PAK5355, PAK5440, PAK5455, PAK6140, PAK6155, PAK6240, PAK6255, PAK6340, PAK6355, PAK6440, and PAK6455 BIOMET…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0574-2016·2016-01-13

    Corflex Post-Operative Knee Brace Recalled for Potential Locking Failure

    Corflex is recalling 1,406 post-operative knee braces because they may fail to maintain a locked position, potentially causing loss of balance or undesired knee movement.

    Product
    Corflex Contender Post-Op Knee Brace Lite Model: 75-7500-000 Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0578-2016·2016-01-13

    Corflex Post-Operative Knee Brace Recalled for Potential Locking Failure

    Corflex is recalling 10 units of the Brielle Ortho Contender Post-Op-Knee Brace Lite because the brace may fail to maintain its locked position, potentially causing loss of balance or undesired knee movement.

    Product
    BRIELLE ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-087 Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0596-2016·2016-01-13

    Philips Lumify Diagnostic Ultrasound Recalled for Color Flow Display Error

    Philips is recalling 21 Lumify Diagnostic Ultrasound units in the US because a software error displays Color Flow direction incorrectly, which could lead to misdiagnosis.

    Product
    Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216 Part Number: 989605449841 with 453561845331 (software version 1.0)
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0577-2016·2016-01-13

    Corflex Post-Operative Knee Brace Recalled for Potential Locking Failure

    Corflex is recalling 42 units of the Contender Post-Op-Knee Brace Lite because the brace may fail to maintain its locked position, potentially causing loss of balance or undesired knee movement.

    Product
    ORTHO SPEC GRP CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-075 Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0605-2016·2016-01-13

    Baxter Y-Type Spike Adapter Recalled for Potential Particulate Matter

    Baxter Healthcare is recalling Y-Type Spike Adapters due to the potential presence of dark loose particulate matter on the spike.

    Product
    Baxter Y-Type Spike Adapter, 7" (18 cm), 1C8433, Product Usage: C8433: For the administration of fluids from a container into the patients vascular system through a vascular access device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0334-2016·2016-01-13

    Made In Nature Recalls Sriracha Chili Kale Chips for Undeclared Soy

    Made In Nature is recalling Sriracha Chili Kale Chips due to undeclared soy allergen from Tamari. The recall covers 50,176 units distributed nationwide.

    Product
    Made In Nature Sriracha Chili Kale Chips, 2.2oz or 62g, In a clamshell container with a paper sleeve, 8 packages per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0593-2016·2016-01-13

    Biomet 3i Dental Impression Copings Recalled for Inadequate Biocompatibility Testing

    Biomet 3i is recalling specific dental impression copings due to inadequate biocompatibility testing. The devices are distributed worldwide, including in the US.

    Product
    BIOMET 3i, PROVIDE IMPRESSION COPINGS, Catalog # PIC484, PIC484H, PIC485, PIC485H, PIC654, PIC654H, PIC655, and PIC655H BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0572-2016·2016-01-13

    Partners In Medicine Recalls CNSystems Task Force Monitor 3040i for Blood Pressure Errors

    Partners In Medicine is recalling 28 CNSystems Task Force Monitor 3040i devices because they may provide incorrect blood pressure readings for some patients.

    Product
    CNSystems TASK FORCE MONITOR 3040i, plethysmograph, impedance. Noninvasively measure and display patient's hemodynamic parameters time synchronized using Impedance Cardiography (ICG), Electrocardiography (ECG), oscillometric Blood Pressure (oscBP) and continuous Blood Pressure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0594-2016·2016-01-13

    Biomet 3i Recall Dental Impression Coping Kits for Biocompatibility Testing

    Biomet 3i is recalling 30,111 Provide Impression Coping Kits worldwide due to inadequate biocompatibility testing.

    Product
    BIOMET 3i, PROVIDE IMPRESSION COPING KITS, Catalog # PRK484, PRK485, PRK654, and PRK655 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·16V009000·2016-01-13

    Turtle Top Recalls Wheelchair Lifts Due to Bearing Failure Risk

    Turtle Top is recalling specific wheelchair lifts installed in Odyssey and Terra Transport vehicles because pivot holes may allow bearings to move, risking platform failure.

    Product
    TURTLE TOP — TURTLE TOP ODYSSEY XL, ODYSSEY LT, ODYSSEY, TERRA TRANSPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V008000·2016-01-13

    Newmar Recalls Motorhomes Due to Unstable Electric Entry Steps

    Newmar is recalling specific 2008-2015 motorhomes because a bolt on the electric steps may fracture, causing the steps to become unstable and increasing the risk of injury.

    Product
    NEWMAR — NEWMAR BAY STAR, DUTCH STAR, VENTANA, CANYON STAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V010000·2016-01-13

    Champion Bus Recalls 2009-2015 Models Due to Seat Belt Anchor Defect

    Champion Bus is recalling 2009-2015 Crusader, Stacked Rail, and CTS-RE vehicles because missing welds on seat brackets could cause seat belts to detach in a crash.

    Product
    CHAMPION — CHAMPION CTS-RE, STACKED RAIL, CRUSADER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0589-2016·2016-01-13

    Maquet HCU 30 Heater-Cooler Unit Recalled for Power Supply Board Failure

    Maquet is recalling HCU 30 Heater-Cooler Units due to a power supply board defect that can cause overheating and unit shutdown during cardiopulmonary bypass procedures.

    Product
    Maquet HCU 30 Coolant Type R134A Filling weight 250 g 120 V 50-60 Hz 1920 W Product Usage: The Heater Cooler Unit (HCU) 30 is intended to circulate water through heat exchange circuits to warm or cool a patient during short duration cardiopulmonary bypass procedures lasting 6…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0335-2016·2016-01-13

    Made In Nature Recalls Sriracha Kale Chips Due to Undeclared Soy Allergen

    Made In Nature is recalling Sriracha Chili Kale Chips and Pacific Superfoods Snack Lava Rock Sriracha Kale Chips because they contain undeclared soy from Tamari.

    Product
    Pacific Superfoods Snack Lava Rock Sriracha Kale Chips, 2.2oz or 62g, In a clamshell container with a paper sleeve, 8 packages per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0580-2016·2016-01-13

    Corflex Post-Operative Knee Brace Recalled for Potential Locking Failure

    Corflex is recalling 80 post-operative knee braces that may fail to maintain the locked position, potentially causing loss of balance or undesired knee movement.

    Product
    CONTENDER POST-OP-KNEE BRACE FULL FOAM Model: 75-7550-000 Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0601-2016·2016-01-13

    3M Coban Self-Adherent Wrap Recalled for Latex Mislabeling

    3M is recalling Coban Self-Adherent Wrap mislabeled as latex-free because it actually contains latex, posing a risk to users with latex sensitivity.

    Product
    3M Coban Self-Adherent Wrap Shipper carton label identified the product as 3M Coban LF Latex Free Catalog #2081, lot number 2018-10AM.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0579-2016·2016-01-13

    Corflex Post-Operative Knee Brace Recalled for Potential Locking Failure

    Corflex is recalling specific Post-Operative Knee Brace Lite models because they may fail to maintain the locked position, potentially causing loss of balance or undesired knee movement.

    Product
    ADV ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-231 Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0573-2016·2016-01-13

    Smith & Nephew Recalls Mislabelled 35mm Patellar Knee Implant Components

    Smith & Nephew is recalling 20 units of 35mm patellar knee implants incorrectly labeled as 32mm. The size mismatch prevents proper alignment of pegs during surgery.

    Product
    Smith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR COMPONENT, RESURFACING ROUND, 32MM STANDARD, FOR CEMENTED USE ONLY WITH JOURNEY PEG, STERILE EO, Rx only, REF Number: 71934490 knee implant.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0604-2016·2016-01-13

    Elekta Oncentra VMAT Radiation Therapy Planning System Recalled for Software Error

    Elekta, Inc. is recalling 154 units of the Oncentra External Beam - VMAT radiation therapy planning system because a software error may cause the system to incorrectly include organs at risk as target volumes.

    Product
    Oncentra External Beam - VMAT - Radiation therapy planning system Product Usage: The Oncentra system is a radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.
    Category
    Medical Device
    Distribution
    Distributed nationwide