The Recall Desk

Manufacturer

Epimed International, Inc.

4 recalls in our database name Epimed International, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
4
Critical
0
Severe
0
Most recent
2021-03-24

Of the 4 recalls from Epimed International, 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.

1–4 of 4

  • HighFDA (Devices)·Z-1276-2021·2021-03-24

    Epimed Feth-R-Kath Catheter Recalled for Coating Deterioration

    Epimed International is recalling Feth-R-Kath Catheters because the outer coating may crack or flake off. The recall covers 5,835 units distributed nationwide.

    Product
    Feth-R-Kath Catheter, 19g x 24". Intended Use:Radlo Opaque Epidural Catheter Catalog #: 157-1924 Intended for epidural anesthesia and is limited to placement of 72 hours or less
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2069-2019·2019-07-31

    Epimed Versa-Kath Mini Kit Recalled for Incorrect Catheter Size Labeling

    Epimed International is recalling 98 Versa-Kath Mini Kits because the labeling incorrectly states the kit contains a 12-gauge catheter, while it actually contains a 21-gauge catheter.

    Product
    Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 units, Sterile ED, REF 181-2112, RX, (01) 108187880213945, LOT 31129344 for epidural or caudal anesthesia
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-2068-2019·2019-07-31

    Epimed Versa-Kath Mini Kit Recalled for Incorrect Catheter Size Labeling

    Epimed International is recalling 200 Versa-Kath Mini Kits because the labeling incorrectly states a 12-gauge catheter is included, while the kit actually contains a 21-gauge catheter.

    Product
    Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 units, Sterile ED, REF 181-2112, RX, (01) 108187880213945, LOT 311291155 for epidural or caudal anesthesia
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0086-2017·2016-11-09

    Epimed 15 g R.K. Epidural Needle Recall for Catheter Coating Risk

    Epimed International is recalling 576 units of 15 g R.K. Epidural Needles because they may skive a catheter's outer coating, posing a risk of retained catheter fragments.

    Product
    15 g R.K. Epidural Needle (TW), Catalog #/REF #100-1415 Intended for the epidural placement, directly or through an epidural catheter, of anesthetic agents to elicit regional anesthesia
    Category
    Medical Device
    Distribution
    6 states