The Recall Desk

Hazard

Improper Reprocessing recalls

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

What the numbers show

Total
9
Critical
0
Severe
0
Most recent
2024-10-02

Of the 9 improper reprocessing 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 improper reprocessing 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.

1–9 of 9

  • HighFDA (Devices)·Z-3223-2024·2024-10-02

    Karl Storz Hopkins Telescope 6 Endoscope Recalled for Unapproved Reprocessing Instructions

    Karl Storz Hopkins Telescope 6 endoscopes (59 units, nationwide) are recalled because their reprocessing instructions lack FDA review and approval for safety and efficacy.

    Product
    Karl Storz - Endoskope , REF: 27295AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-2689-2024·2024-08-28

    Disposable 5 Lead Cable System May Contain Non-Approved ECG Leads

    Stryker Sustainability Solutions is recalling disposable 5 lead cable systems that may contain non-approved ECG leads which were improperly reprocessed. The wrong components may cause devices to malfunction.

    Product
    Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2562-2021·2021-10-06

    LYMOL Medical Elite X Class Rigid Bronchoscope System — Updated reprocessing instructions not distributed

    Lymol Medical Corporation recalled the LYMOL Medical Elite X Class Rigid Bronchoscope System because updated reprocessing instructions issued November 15, 2020, were not sent to all consignees of the devices.

    Product
    LYMOL Medical Elite X Class Rigid Bronchoscope System, Part No. BD2410, BB2701, BB2702, BB2401, BB2402, BA2700, BT2000, BT2101, BT2103, BT2105, BT2106, BT2210, BT2201, BT2203, BT2205, BR2200, BP2200, BI2200, BR2000, BP2000, BI2999, BR2103, BP2103, BI2103, BR2101, BP2101, BI2101,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2568-2021·2021-10-06

    Olympus BF-P60 Bronchofiberscope Reprocessing Instructions Updated to Meet FDA Guidance

    Olympus Corporation has issued new, validated reprocessing instructions for the BF-P60 OES Bronchofiberscope to comply with FDA guidance. The recall affects 1,030 devices distributed nationwide and internationally.

    Product
    BF-P60 OES Bronchofiberscope, Model No. BF-P60
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2572-2021·2021-10-06

    Olympus BF-1T180 Bronchovideoscope Reprocessing Instructions Updated

    Olympus Corporation is issuing updated reprocessing instructions for the BF-1T180 EVIS EXERA II Bronchovideoscope to comply with FDA 2015 guidance on medical device reprocessing validation.

    Product
    BF-1T180 EVIS EXERA II Bronchovideoscope, Model No. BF-1T180
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0224-2019·2018-10-31

    Nakanishi SGS Surgical Handpieces Recalled for Updated Reprocessing Instructions

    Nakanishi Inc. is recalling 1,662 SGS-E2S surgical handpieces because reprocessing instructions were updated to include manual cleaning and specific autoclave parameters.

    Product
    Micro Surgery Handpiece SGS, Model: SGS-E2S, Order Code: H266, Manufactured by: Nakanishi Inc The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible..
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0221-2019·2018-10-31

    Nakanishi SGA-E Surgical Handpieces Recalled for Updated Reprocessing Instructions

    Nakanishi Inc. is recalling 18 SGA-E surgical handpieces because reprocessing instructions were updated to include manual cleaning and specific autoclave sterilization parameters.

    Product
    Surgical Handpiece, Model: SGA-E Order Code: H083, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.
    Category
    Medical Device
    Distribution
    5 states