The Recall Desk

Manufacturer

FEMSelect Ltd

1 recall in our database name FEMSelect Ltd as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2022-02-09

Of the 1 recalls from FEMSelect Ltd 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-0556-2022·2022-02-09

    Pelvic floor repair device may lack required packaging component

    FEMSelect Ltd is recalling 141 units of the EnPlace trans-vaginal pelvic floor repair system because certain lots may not have been packaged with the required Channel Tube Limiter accessory.

    Product
    The EnPlace is a single use trans-vaginal pelvic floor repair system which enables delivery of a tissue anchor to the ligaments of the vaginal cavity. The anchors are pre-loaded inside the device shaft and are ready for use. A thimble is also supplied, as an accessory for the
    Category
    Medical Device
    Distribution
    Distributed nationwide