The Recall Desk

Hazard

Sterilization recalls

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

What the numbers show

Total
53
Critical
0
Severe
0
Most recent
2024-10-02

Of the 53 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 0 (0%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all 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.

1–25 of 53

  • HighFDA (Devices)·Z-3222-2024·2024-10-02

    FDA Recalls Karl Storz Endoscopes Due to Unapproved Reprocessing Instructions

    Karl Storz is recalling 78 endoscopes because their instructions for use contain reprocessing modalities that have not been reviewed or approved by the FDA.

    Product
    Karl Storz - Endoskope , REF: 27294AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2342-2023·2023-08-16

    Olympus OER-Pro Endoscope Reprocessor Revised Labeling for Equipment Compatibility

    Olympus revised OER-Pro labeling because two endoscope models (LF-V, LF-P) are no longer compatible. Sterilization parameters and cleaning procedures have also changed.

    Product
    Olympus Endoscope Reprocessor OER-Pro-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2343-2023·2023-08-16

    Olympus Endoscope Reprocessor OER-Mini Labeling Revised for Device Compatibility

    Olympus revised labeling for the OER-Mini endoscope reprocessor. The company removed LF-V and LF-P endoscopes from the list of compatible devices and updated sterilization procedures.

    Product
    Olympus Endoscope Reprocessor OER-Mini-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0560-2023·2022-12-21

    DeRoyal Minor Oral and ENT Procedure Packs Recalled for Defective Steri Drapes

    DeRoyal procedure packs distributed across multiple U.S. states are being recalled because they contain previously recalled 3M Steri Drapes. Affected healthcare facilities should stop using the packs and contact the manufacturer.

    Product
    DeRoyal MINOR ORAL / ENT PACK, REF 89-2576.15
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-3037-2018·2018-09-19

    Recall of Boston Scientific Tracheobronchial Stents Due to Sterilization Labeling Error

    SPS Sterilization, Inc. is recalling two Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stents because the expiration date on the labeling exceeds the validated shelf life.

    Product
    Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stent, 24MM X 70MM | 75CM L, resterilized.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-2180-2015·2015-07-29

    FDA Recalls Fiber Stripper Tools Due to Cleaning Validation Issues

    American Medical Systems is recalling 16,710 Fiber Stripper tools because cleaning and sterilization validation data do not meet FDA guidance for reusable products.

    Product
    Tool, Stripper W/BLD, 44S, Nonautoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0768-2015·2014-12-24

    Stryker Endoscopy Recalls Bullet Forceps Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 units of 3mm Bullet Forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 3MM INSERT, BULLET FORCEPS, 20CM, P/N 0250282010 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) ports
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0611-2015·2014-12-24

    Stryker Endoscopy Recalls Fixable Cone for 11mm Hasson Due to Sterilization Labeling

    Stryker Endoscopy is recalling 180,573 units of the Fixable Cone for 11mm Hasson because the instructions for use do not support specific sterilization methods.

    Product
    PKG, FIXABLE CONE FOR 11MM HASSON, P/N 0250080180. 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) ports wh
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0742-2015·2014-12-24

    Stryker Endoscopy Recalls Park Forceps Due to Sterilization Instructions

    Stryker Endoscopy is recalling specific Park Forceps instruments because the instructions for use do not support certain sterilization methods.

    Product
    PKG, 5MM INSERT, 45CM, PARK FORCEPS, P/N 0250080745 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) ports wh
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0774-2015·2014-12-24

    Stryker Endoscopy Recalls 3mm PEEK Multi-Function Handle Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 units of 3mm PEEK Multi-Function Handles because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 3MM PEEK MULTI-FUNCTION HANDLE, P/N 0250282046 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) ports wh
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0683-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Forceps Due to Sterilization Instructions

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

    Product
    PKG, STRONG FORCEPS, FENESTRATED, P/N 0250080320. 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) ports whic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0622-2015·2014-12-24

    Stryker Laparoscopic Manual Instruments Recalled Due to Sterilization Documentation Error

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

    Product
    PKG, ROTATING HANDLE, RATCHET, INSULATED SHAFT, P/N 0250080231. 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0649-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Documentation Error

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

    Product
    PKG, MICRO SCISSORS, CURVED, P/N 0250080270. 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) ports which al
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0605-2015·2014-12-24

    Stryker Laparoscopic Cannula Recall Due to Sterilization Instructions

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

    Product
    PKG, CANNULA 5.5MM AUTOMATIC VALVE STOP COCK W/O TROCAR, P/N 0250080171. 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 f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0737-2015·2014-12-24

    Stryker Endoscopy Recalls Fenestrated Forceps Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 fenestrated forceps units because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 5MM, 45CM, INSERT, FENESTRATED FORCEPS, P/N 0250080732 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
  • ModerateFDA (Devices)·Z-0685-2015·2014-12-24

    Stryker Laparoscopic Grasper Forceps Recalled Due to Sterilization Instructions

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

    Product
    PKG, GRASPER FORCEPS, DELICATE, FENESTRATED, P/N 0250080322. 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
  • ModerateFDA (Devices)·Z-0679-2015·2014-12-24

    Stryker Endoscopy Recalls Alligator Forceps Due to Sterilization Instructions

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

    Product
    PKG, ALLIGATOR FORCEPS, P/N 0250080316. 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) ports which allow th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0593-2015·2014-12-24

    Stryker Endoscopy Recalls Bipolar Forceps Due to Sterilization Instructions

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

    Product
    PKG, BIPOLAR FORCEPS, FENESTRATED, 33CM, P/N 0250080120 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) port
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0690-2015·2014-12-24

    Stryker Laparoscopic Needle Holder Recall Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 laparoscopic needle holders because the instructions for use do not support specific sterilization methods.

    Product
    PKG, NEEDLE HOLDER, CURVED LEFT, P/N 0250080341. 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) ports which
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0728-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Labeling

    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 INSERT, PADDLE BABCOCK, 33CM, P/N 0250080700 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) ports
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0758-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Scissors Due to Sterilization Documentation Error

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

    Product
    PKG, 3MM INSERT, METZENBAUM, CURVED, LONG SCISSORS, 20CM, P/N 0250282000 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 fr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0796-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Labeling

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

    Product
    PKG, 3MM X 29CM INSERT, RIGHT ANGLE DISSECTOR, LONG JAW, P/N 0250282105 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 fre
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0793-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Instruments Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 laparoscopic instruments because the provided instructions do not support specific sterilization methods.

    Product
    PKG, 3MM INSERT, ATRAUMATIC GRASPER, DOUBLE ACTION, 29CM, P/N 0250282101 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 fr
    Category
    Medical Device
    Distribution
    Distributed nationwide