The Recall Desk

Hazard

Product Failure recalls

31 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
31
Critical
0
Severe
4
Most recent
2024-07-24

Of the 31 product failure recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (13%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all product failure recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–25 of 31

  • HighFDA (Devices)·Z-2375-2024·2024-07-24

    Blood collection tubes recalled for missing additive and separation failures

    Greiner Bio-One is recalling VACUETTE blood collection tubes due to missing additive affecting clotting and separation. Defective tubes could delay patient treatment if samples require recollection.

    Product
    VACUETTE¿ TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2611-2020·2020-07-22

    Medtronic Bone Void Filler Recalled for Potential Failure to Set Properly

    Skeletal Kinetics is recalling Medtronic Bone Void Filler kits that may not maintain setting characteristics, potentially increasing surgical time or causing bone formation issues.

    Product
    MEDTRONIC BONE VOID FILLER, SMALL. Product Number: C07A, UDI: 813845020504 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2594-2020·2020-07-22

    Skeletal Kinetics Recalls Acumed Callos Bone Void Filler Kits

    Skeletal Kinetics is recalling Acumed Callos bone void filler kits because they may not maintain setting characteristics for the labeled shelf life.

    Product
    ACUMED CALLOS INJECT 5CC. Product Number: 65-0005-S, UDI: 813845020238 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created fro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2597-2020·2020-07-22

    Skeletal Kinetics Recalls Craniosculpt C Bone Void Filler Kits

    Skeletal Kinetics is recalling Craniosculpt C bone void filler kits because they may not maintain setting characteristics for the labeled shelf life, potentially increasing surgical time or causing bone formation issues.

    Product
    CRANIOSCULPT C, 10CC. Product Number: C-C10CC, UDI: 813845021129 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from trau
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2185-2020·2020-06-10

    Osteomed Recalls Osteovationex Bone Void Filler Due to Shelf-Life Error

    Osteomed is recalling 300 units of Osteovationex 5cc ImpactFormula bone void filler kits because the labeled shelf-life may be incorrect, potentially affecting the product's setting characteristics.

    Product
    OSTEOVATIONEX 5CC IMPACTFORMULA. REF/UDI: 390-0205/00813845020047 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1839-2020·2020-05-13

    Ivoclar Vivadent recalls dental ceramic blocks due to cracking during sintering

    Ivoclar Vivadent AG is recalling 639 units of IPS e.max ZirCAD ceramic blocks because they crack during the sintering process.

    Product
    Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A3 C17/5 - ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/ CAM technology Product Number: 686195
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0719-2020·2020-01-01

    3M Recalls Durapore Advanced Surgical Tape Due to Bond Failure Risk

    3M is recalling Durapore Advanced Surgical Tape because long-term exposure to high moisture may cause bond failure and fiber fraying, posing a risk of accidental ingestion or aspiration.

    Product
    3M Durapore Advanced, Surgical Tape, Model Numbers: 1590-0, 1590-1, 1590-2, 1590-3, 1591-0, 1591-1, 1591-2, 1591-3, 1590S-1, 1590S-2, 1590B-118, 1590B-136
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·19E076000·2019-11-12

    Matrix Alpha Motorcycle Helmets Recalled for Retention System Failure

    Matrix Headgear is recalling Alpha motorcycle helmets because the retention system may fail, allowing the helmet to separate from the head during a crash.

    Product
    EQUIPMENT:MOTORCYCLE:HELMETS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·19E073000·2019-10-21

    H&H Sports Recalls VCAN V531 Motorcycle Helmets for Retention Failure

    H&H Sports Protection is recalling VCAN V531 motorcycle helmets sold on Amazon because the retention system may fail, allowing the helmet to separate from the head during a crash.

    Product
    EQUIPMENT:MOTORCYCLE:HELMETS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0461-2019·2018-11-21

    Medtronic Recalls Parietex Composite Parastomal Mesh Due to Failure Reports

    Medtronic is voluntarily removing Parietex Composite Parastomal Mesh from the market after receiving reports of product failure leading to hernia recurrence.

    Product
    Parietex Composite Parastomal Mesh (Product Number PCOPM15 / PCOPM20) Product Usage: The PCOPM15 and PCOPM20 reorder codes are circular in shape, made from a three-dimensional monofilament polyester fabric with a two-dimensional monofilament polyester central band. One side o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2360-2018·2018-07-11

    Biocare Medical Recalls Vulcan Fast Red Chromogen Kit Due to Stability Issue

    Biocare Medical is recalling Vulcan Fast Red Chromogen Kit 2 because a stability issue in the buffer prevents the chromogen from developing.

    Product
    Vulcan Fast Red Chromogen Kit 2, part of an immunohistochemistry (IHC) procedure using an alkaline phosphatase (AP) detection system. Catalog numbers FR805-5L and FR805S
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-1385-2015·2015-04-15

    Intuitive Surgical Recalls da Vinci Si Camera Head Drapes

    Intuitive Surgical is recalling da Vinci Si Camera Head Drapes due to a cloudy or waxy appearance that may transfer to patients or cause the drape to tear.

    Product
    da Vinci Si Surgical System IS3000, Camera Head Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1247-2015·2015-03-18

    Arjo Pressure IQ Evolve Mattress Recalled for Pressure Ulcer Risk

    Arjo is recalling 1,034 Pressure IQ Evolve mattresses nationwide due to failures that resulted in pressure ulcers.

    Product
    Pressure IQ Evolve Mattress; Non-powered mattress replacement system. Intended for patients with medium to high risk for developing pressure ulcers while on a mattress.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·14745·2014-08-21

    StoveTop FireStop Microhood Recalled Due to Fire Suppression Failure Risk

    WilliamsRDM is recalling StoveTop FireStop Microhood units because the front canister may fall off and fail to suppress fires. No injuries have been reported.

    Product
    The StoveTop FireStop® Microhood™ Fire Suppressors
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2169-2014·2014-08-20

    Abbott 5 mL Reaction Vessels Recalled for Insufficient Rim Defect

    Abbott Molecular is recalling 5 mL Reaction Vessels for the m2000sp system because an insufficient rim may cause the vessels to drop through the carrier.

    Product
    5 mL Reaction Vessels (a consumable of the Abbott m2000sp Automated Fluid Handling System). The Abbott m2000 RealTime System is intended for use in performing nucleic acid amplification testing by polymerase chain reaction in clinical laboratories. The system is comprised of the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1273-2013·2013-05-15

    Cypress Medical Recalls MediChoice Umbilical Cord Clamps Due to Breakage

    Cypress Medical Products LLC is voluntarily recalling one lot of MediChoice Umbilical Cord Clamps because they are breaking upon use.

    Product
    Cypress Medical Products LLC, MediChoice Umbilical cord clamp, sterile; single use; Distributed by Owens & Minor, Mechanicsville, VA. The product is used to clamp the umbilical cord after childbirth.
    Category
    Medical Device
    Distribution
    1 state
  • HighNHTSA·13E021000·2013-04-25

    Cequent Pro Series Translite Bike Racks Recalled for Cradle Tearing

    Cequent is recalling Pro Series Translite Bike Racks because cradles may tear, allowing bikes to fall onto the roadway and create a crash hazard.

    Product
    EQUIPMENT:MECHANICAL:CARRIER/RACK recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0838-2013·2013-02-27

    Ansell Recalls LifeStyles ZERO 10 Latex Condoms Due to Breakage Complaints

    Ansell Healthcare Products LLC is voluntarily recalling LifeStyles ZERO 10 latex condoms due to complaints about difficulty unrolling and breakage.

    Product
    LifeStyles ZERO 10 uber-thin lubricated latex condoms. Mfd. for Ansell Healthcare Products LLC, Dothan, AL 96303. A sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·13703·2012-10-25

    FLO Cycling Recalls Bicycle Wheel Rim Tape Due to Fall Hazard

    FLO Cycling is recalling about 800 units of yellow plastic rim tape sold with specific wheels because the tape can fail, causing inner tubes to burst and posing a fall hazard.

    Product
    Bicycle Wheel Rim Tape
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·12190·2012-05-31

    English Riding Supply Recalls Happy Mouth Wire Bits for Injury Risk

    English Riding Supply is recalling Happy Mouth wire bits for horses because the steel wire can break, causing riders to fall and suffer injuries.

    Product
    Happy Mouth Wire Mouth Bits
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·11138·2011-02-22

    EB Brands Recalls Resistance Stretch Tubing Due to Injury Hazard

    EB Brands is recalling approximately 29,700 units of resistance stretch tubing because the handles can break or detach, posing an injury risk to users.

    Product
    Resistance Stretch Tubing
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·09266·2009-07-09

    Kidde Recalls Dual Sensor Smoke Alarms That May Fail to Warn of Fire

    Kidde is recalling about 94,000 Model PI2000 dual sensor smoke alarms because electrostatic discharge can damage the unit, causing it to fail to warn of a fire.

    Product
    Kidde Model PI2000 Dual Sensor Smoke Alarms
    Category
    Consumer Product
    Distribution
    Distributed nationwide