The Recall Desk

Hazard

Inadequate Sterilization recalls

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

What the numbers show

Total
92
Critical
0
Severe
2
Most recent
2026-08-19

Of the 92 inadequate sterilization recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (2%) 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 inadequate sterilization 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.

76–92 of 92

  • ModerateFDA (Devices)·Z-0625-2020·2019-12-18

    Integra CUSA Clarity System Recalled for Inadequate Sterilization Tray Drying Time

    Integra LifeSciences is recalling 820 CUSA Clarity Ultrasonic Tissue Ablation Systems because the 36 kHz Sterilization Tray requires 40 minutes to dry, not the 30 minutes stated in the manual.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0618-2020·2019-12-18

    Integra LifeSciences Recalls C7000 CUSA Clarity Ultrasonic Tissue Ablation Systems

    Integra LifeSciences is recalling 820 C7000 CUSA Clarity systems because the 36 kHz Sterilization Tray does not meet the 30-minute drying time criteria stated in the manual.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0632-2020·2019-12-18

    Integra CUSA Clarity System Recalled for Sterilization Tray Drying Defect

    Integra LifeSciences is recalling 820 CUSA Clarity Ultrasonic Tissue Ablation Systems because the sterilization tray does not meet the required drying time criteria.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0627-2020·2019-12-18

    Integra C7000 CUSA Clarity System Recalled for Sterilization Tray Drying Defect

    Integra LifeSciences is recalling 820 C7000 CUSA Clarity systems because the 36 kHz Sterilization Tray fails to meet the 30-minute drying time criteria stated in the manual.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0615-2020·2019-12-18

    Integra C7000 CUSA Clarity System Recalled for Sterilization Tray Drying Defect

    Integra LifeSciences is recalling 820 C7000 CUSA Clarity Ultrasonic Tissue Ablation Systems because the 36 kHz Sterilization Tray does not meet the required 30-minute drying time criteria.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0620-2020·2019-12-18

    Integra C7000 CUSA Clarity System Recalled for Inadequate Sterilization Tray Drying Time

    Integra LifeSciences is recalling 820 C7000 CUSA Clarity systems because the Spanish operator manual incorrectly states a 30-minute drying cycle, whereas 40 minutes are required for complete drying.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0645-2020·2019-12-18

    Integra C7000 CUSA Clarity System Recalled for Sterilization Tray Drying Defect

    Integra LifeSciences is recalling the C7000 CUSA Clarity Ultrasonic Tissue Ablation System because the 36 kHz Sterilization Tray does not meet the 30-minute drying time criteria stated in the manual.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0641-2020·2019-12-18

    Integra LifeSciences Recalls C7000 CUSA Clarity Ultrasonic Tissue Ablation System

    Integra LifeSciences is recalling the C7000 CUSA Clarity Ultrasonic Tissue Ablation System because the 36 kHz Sterilization Tray does not meet the required dry time criteria.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0614-2020·2019-12-18

    Integra C7000 CUSA Clarity System Recalled for Drying Time Discrepancy

    Integra LifeSciences is recalling 820 C7000 CUSA Clarity systems because the operator manual underestimates the required drying time for sterilization trays.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Devices)·Z-2959-2018·2018-09-12

    Steris Recalls V-PRO Low Temperature Sterilization Systems Due to Sterilant Expiration Defect

    Steris Corporation is recalling 2,889 V-PRO low temperature sterilization systems because they may fail to detect expired sterilant cups after a power cycle.

    Product
    AMSCO V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems The V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems, using VAPROX HC Sterilant, are intended for use in the terminal Sterilization of properly prepared (cleaned, rinsed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2535-2017·2017-06-21

    Cook Inc. Recalls Pereyra Ligature Carrier 75 Due to Reprocessing Instructions

    Cook Inc. is recalling 29 Pereyra Ligature Carrier 75 devices because their reprocessing instructions do not provide sufficient detail for cleaning, disinfection, and sterilization.

    Product
    Pereyra Ligature Carrier 75
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0748-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 units of laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 5MM X 33CM, INSERT, FENESTRATED GRASPER, P/N 0250080755 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1872-2014·2014-07-02

    Stryker Shaver Handpiece Sterilization Tray Recalled for Validation Deficiencies

    Stryker Endoscopy is recalling 1,992 Shaver Handpiece Sterilization Trays because the provided STERRAD 100S sterilization parameters did not fully consider all worst-case scenarios during validation testing.

    Product
    Shaver Handpiece Sterilization Tray. Model number 272-700-000. For sterilization of Stryker Endoscopy arthroscopic shaver.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1544-2014·2014-05-14

    Stryker 12-Instrument Sterilization Tray Recalled for Validation Testing Gaps

    Stryker Endoscopy is recalling 2,591 12-Instrument Sterilization Trays because gravity sterilization parameters in the reprocessing guide did not fully consider all worst-case scenarios during validation testing.

    Product
    12-Instrument Sterilization Tray; Product Usage: The 12-Instrument Tray is used to hold and protect surgical instruments during the sterilization process. Specifically, this tray is used for the Conquest Manual Instrument line. The tray consists of an interlocking tray and li
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0357-2014·2013-11-27

    Zimmer Trinica Anterior Lumbar Plate Instrument Tray Recall for Sterilization Issues

    Zimmer Spine is recalling Trinica ALP Instrument Trays because ratchet handles may not sterilize effectively due to tray design interference.

    Product
    Trinica Anterior Lumbar Plate (ALP) system, part 07.01058.001. Non Sterile, Rx only. The Trinica Anterior Lumbar Plate System is a temporary supplemental fixation device consisting of a variety of shapes and sizes of plates and screws. The Trinica Anterior Lumbar Plate System i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1157-2013·2013-05-01

    Spinal Solutions Recalls APLIF Implants Due to Inadequate Testing

    Spinal Solutions is recalling 220 APLIF implants because they lack adequate testing to prove safety. The defect could cause implant breakage or movement.

    Product
    APLIF Implants and Instruments, Part Numbers: 184008-10 Anterior Psoas Lumbar 18 x 40 x 08mm - 10degree 184010-10 Anterior Psoas Lumbar 18 x 40 x 10mm - 10degree 184012-10 Anterior Psoas Lumbar 18 x 40 x 12mm - 10degree 184014-10 Anterior Psoas Lumbar 18 x 40 x 14mm - 10d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1156-2013·2013-05-01

    Orthopedic Alliance Recalls Blue & Gold Spine System Implants

    Orthopedic Alliance LLC is recalling Blue & Gold Spine System implants and instruments because the system lacks adequate testing and documentation to demonstrate it meets performance or safety standards.

    Product
    Orthopedic Alliance Spine System (alias "Blue & Gold") Part Numbers: BGC3010 Screw Cap BGR0040 Straight Rod 5.5 x 40mm BGR0050 Straight Rod 5.5 x 50mm BGR0060 Straight Rod 5.5 x 60mm BGR0070 Straight Rod 5.5 x 70mm BGR0080 Straight Rod 5.5 x 80mm BGR0090 Straight Rod
    Category
    Medical Device
    Distribution
    1 state