The Recall Desk

Manufacturer

Mani, Inc. - Kiyohara Facility

3 recalls in our database name Mani, Inc. - Kiyohara Facility as the manufacturing or recalling firm.

What the numbers show

Total
3
Critical
0
Severe
0
Most recent
2023-05-03

Of the 3 recalls from Mani, Inc. - Kiyohara Facility 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 listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–3 of 3

  • HighFDA (Devices)·Z-1468-2023·2023-05-03

    Mani Trocar Kits Recalled for Packaging Defect Compromising Sterility

    Mani Trocar Kits (Models MTK23S and MTK25S) are being recalled due to a packaging defect that may compromise the sterile barrier. The recall affects 45 kits distributed to one consignee in Missouri.

    Product
    Mani Trocar Kit, Model MTK23S and Model MTK25S There are 3 kits contained in one box, and sterile 1 kit consists of 3 pcs. trocar with the valved cannula and 1 pc. infusion cannula.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0558-2021·2020-12-16

    MANI Infusion Cannula 23G S Recalled for Luer Connector Defects

    Mani, Inc. is recalling MANI Infusion Cannula 23G S units because Luer connector dimensions are out of specification, which may cause fluid leakage or unintended disconnection during ophthalmic surgery.

    Product
    MANI Infusion Cannula 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery Ref: MTC 23S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0557-2021·2020-12-16

    Mani Trocar Kit 23G S Recalled for Luer Connector Defects

    Mani, Inc. is recalling Trocar Kit 23G S units because Luer connector dimensions are out of specification, which may cause fluid leakage or disconnection during ophthalmic surgery.

    Product
    MANI TROCAR KIT 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery, Ref: MTK 23S
    Category
    Medical Device
    Distribution
    Distributed nationwide