The Recall Desk

Manufacturer

RGI Medical Manufacturing, Inc.

1 recall in our database name RGI Medical Manufacturing, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2014-07-16

Of the 1 recalls from RGI Medical Manufacturing, Inc. 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.

1–1 of 1

  • HighFDA (Devices)·Z-1996-2014·2014-07-16

    RGI Medical Recalls 300psi I.V. Catheter Extension Sets

    RGI Medical is recalling 19,200 units of Henora 300psi I.V. Catheter Extension Sets due to a defect that may cause the tubing to separate from the luer connection during use.

    Product
    Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide