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.

21751–21775 of 50426

  • HighFDA (Devices)·Z-0391-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 49 mm Number: 00-8065-946-32
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0374-2021·2020-11-11

    Zimmer Biomet Recalls Acetabular Hip Prosthesis Cups Due to Sterilant Concerns

    Zimmer Biomet is recalling 412 acetabular hip prosthesis cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 53 mm Number: 00-8065-650-32
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0313-2021·2020-11-11

    GE Datex-Ohmeda Aisys CS2 Anesthesia System Recalled for Damaged Flow Sensors

    GE Healthcare is recalling 101 Aisys CS2 Anesthesia Systems because flow sensors may have damaged tubes, posing a risk to patients.

    Product
    GE Datex-Ohmeda Aisys CS2 Anesthesia System - Product Usage: is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric adult). The device is intended for volume or pressure control ventilation.
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Devices)·Z-0327-2021·2020-11-11

    Zimmer Biomet Recalls Acetabular Hip Prosthesis Cups Due to Sterilant Concerns

    Zimmer Biomet is recalling 412 acetabular hip prosthesis cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 47 mm Item Number: 00-8065-544-26
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0350-2021·2020-11-11

    Zimmer Biomet Recalls Acetabular Hip Cups Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 acetabular hip cups because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 59 mm Number: 00-8065-556-26
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0362-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Cups Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 47 mm Number: 00-8065-644-28
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0386-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 59 mm Number: 00-8065-656-32
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0363-2021·2020-11-11

    Zimmer Biomet Recalls Acetabular Hip Cup Components Due to Sterilant Concerns

    Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 49 mm Number: 00-8065-646-22
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0337-2021·2020-11-11

    Zimmer Biomet Recalls Acetabular Hip Cups Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 acetabular hip cup components because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 53 mm Item Number: 00-8065-550-22
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0395-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 57 mm Number: 00-8065-954-32
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·21025·2020-11-10

    Salsa Cutthroat Bicycles Recalled Due to Fork Crack Injury Hazard

    Quality Bicycle Products is recalling Salsa Cutthroat bicycles because the fork legs can crack or break, posing a fall hazard to riders.

    Product
    Salsa Cutthroat Bicycles and Forks
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·21026·2020-11-10

    Arena Swim Snorkels Recalled by CPSC Due to Choking Hazard

    Arena North America is recalling specific swim snorkels because they can release material that poses a choking hazard. One report of a piece being inhaled has been received.

    Product
    Arena Swim Snorkels Pro II and Swim Snorkels II
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·20V691000·2020-11-10

    2021 Ford F-650 and F-750 Transmission Cooling Line Fire Risk Recall

    Ford is recalling certain 2021 F-650 and F-750 vehicles because the transmission oil cooler line may contact the air conditioning compressor pulley, potentially causing a transmission fluid leak that could lead to an engine compartment fire.

    Product
    FORD — FORD F-650, F-750
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·21029·2020-11-10

    Wintergreen Essential Oil Recalled for Non-Child-Resistant Packaging

    Bolek's Craft Supplys is recalling Crafty Bubbles Wintergreen Essential Oil because the bottles do not meet child-resistant packaging requirements, posing a poisoning risk to young children.

    Product
    Crafty Bubbles Wintergreen Essential Oil
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·20V690000·2020-11-09

    Thomas Built Buses Minotour Recalled for Wheelchair Lift Safety Defect

    Daimler Trucks North America is recalling 2008-2021 Thomas Built Buses Minotour school buses because the wheelchair lift may allow the vehicle to move, increasing injury risk.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES MINOTOUR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20E083000·2020-11-06

    First Light Recalls Illuminated School Bus Stop Signs Due to Seal Defect

    First Light Safety Products is recalling illuminated school bus stop signs sold for specific bus models between April and October 2020. A defective weather seal may allow contaminants to enter, potentially causing electrical shorts and rendering the signs inoperable.

    Product
    EQUIPMENT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V687000·2020-11-06

    2020-2021 Autocar Xpeditor ground cable may cause engine stall

    Certain 2020-2021 Autocar Xpeditor vehicles with X12N engines may have a ground cable that is too short and could fail, causing engine stall without restart capability. Autocar will replace the cable free of charge.

    Product
    AUTOCAR — AUTOCAR XPEDITOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V684000·2020-11-05

    2020 Chevrolet Silverado 1500 Overcured Tire Recall May Increase Crash Risk

    General Motors is recalling certain 2020 Chevrolet Silverado 1500 vehicles with overcured Continental tires that may experience sudden air loss or tread separation, increasing crash risk.

    Product
    GMC — GMC, CHEVROLET, BUICK ACADIA, TRAVERSE, ENCLAVE, XT5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V685000·2020-11-05

    Nissan Recalls 2020 Altima Vehicles Due to Over-Cured Tires

    Nissan is recalling 2,214 2020 Altima S vehicles because specific Continental tires may be over-cured, increasing the risk of a crash.

    Product
    NISSAN — NISSAN ALTIMA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0286-2021·2020-11-04

    Boston Scientific Recalls Hurricane RX Biliary Balloon Catheters Due to Detachment Risk

    Boston Scientific is recalling Hurricane RX Biliary Balloon Dilatation Catheters because the black sheath may detach from the shaft. The recall covers 15,062 units in the US and 12,930 internationally.

    Product
    Hurricane RX Biliary Balloon Dilatation Catheter Catalog REF No. M00545890; M00545900; M00545910; M00545920; M00545930; M00545940; M00545950; M00545960 The device is a double lumen catheter with a balloon mounted at the distal tip. Dilatation balloon catheters are used to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0285-2021·2020-11-04

    Philips Recalls Sterilizable Defibrillator Paddles Due to Undetected Failure Mode

    Philips is recalling 2,202 sterilizable defibrillator paddles because standard periodic checks may fail to detect a specific failure mode in switchless internal models.

    Product
    Philips Sterilizable Defibrillator Paddles, Switchless Internal Paddles, Model Numbers M1741A, M1742A, M1743A, M1744A - Product Usage: used in pairs to transmit a controlled electrical shock from an external defibrillator directly to the exposed heart muscle of a post-pubescent…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0309-2021·2020-11-04

    Battelle Recalls Critical Care Decontamination System N95 Respirators

    Battelle Memorial Institute is recalling 898 N95 respirators decontaminated by its Critical Care Decontamination System. The recall is due to a failure to maintain required condensation levels during the decontamination cycle.

    Product
    Critical Care Decontamination System (CCDS) Compatible N95 respirators - Product Usage: Used in decontaminating compatible N95 respirators2 for multiple-user3 reuse by healthcare personnel (HCP)4 to prevent exposure to pathogenic biological airborne particulates when there are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·21018·2020-11-04

    Rogue Home Timers Recalled by CPSC Due to Fire Hazard

    Coulter Ventures is recalling Rogue Home Timers because the lithium-ion battery can overheat and burn, posing a fire hazard.

    Product
    Rogue Home Timers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0292-2021·2020-11-04

    Pentax 9372HD Digital Capture Software Recall for Patient Data Error

    Pentax of America Inc. is recalling 39 units of the 9372HD Digital Capture system due to a software issue that may copy exam videos to the wrong patient.

    Product
    9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal),
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0293-2021·2020-11-04

    Pentax 9310HD Digital Video Capture Module Recalled for Software Error

    Pentax of America Inc is recalling 39 units of the 9310HD Digital Video Capture Module due to a software issue that may copy patient exam videos to the wrong record.

    Product
    9310HD Digital Video Capture Module with software version 3.4.0 or higher configured with 9263 endoPortal
    Category
    Medical Device
    Distribution
    Distributed nationwide