The Recall Desk

Manufacturer

Epimed International

7 recalls in our database name Epimed International as the manufacturing or recalling firm.

What the numbers show

Total
7
Critical
0
Severe
0
Most recent
2021-08-25

Of the 7 recalls from Epimed International 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.

1–7 of 7

  • HighFDA (Devices)·Z-2313-2021·2021-08-25

    NEO-KATH Caudal Catheter Set Recalled Due to Stylet Protrusion Risk

    Epimed International is recalling the NEO-KATH Caudal Set (REF 201-2430) because the stylet may protrude from the catheter's tip, potentially causing tissue injury. The recall affects 140 units distributed in the US and internationally.

    Product
    NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-2312-2021·2021-08-25

    NEO-KATH Epidural Catheter Set recalled for potential stylet protrusion

    Epimed International recalls NEO-KATH Epidural Catheter Set (Lot 16308275, 16308382) due to potential stylet protrusion from the catheter distal end, which poses injury risk during epidural procedures.

    Product
    NEO-KATH Epidural Catheter Set, REF 200-2430, Sterile
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1850-2020·2020-05-13

    Epimed RF Injector Cannula Recalled for Incorrect Expiration Date Labeling

    Epimed International is recalling 701 units of R-F Injector Cannulas due to incorrect expiration dates on the packaging. The devices were distributed worldwide and across multiple US states.

    Product
    R-F Injector Cannula. 20gx10cm-STERILE. REF/UDI: 257-2010/(01)10818788022124; REF/UDI: 257-2010D(01)00818788022127 - Product Usage:The Epimed RF Introduction Cannula is intended for use in radiofrequency (RF) heat lesion procedures for the relief of pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1849-2020·2020-05-13

    Epimed RF Injector Cannula Recalled for Incorrect Expiration Date

    Epimed International is recalling 1,374 units of RF Injector Cannulas due to incorrect expiration dates on the packaging.

    Product
    R-F Injector Cannula. 18gx10cm-STERILE. REF/UDI: 257-1810/(01)00828788021496; REF/UDI: 257-1810D(01)10818788021493 - Product Usage: The Epimed RF Introduction Cannula is intended for use in radiofrequency (RF) heat lesion procedures for the relief of pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0089-2018·2017-11-15

    Epimed Recalls TUOHY Epidural Needles Due to Potential Sterility Seal Issues

    Epimed International is recalling 263 units of TUOHY Epidural Needles because a partially incomplete seal could impact the product's sterility.

    Product
    TUOHY Epidural Needle, 20g x 3.5in(8.9cm) TW, 10 units, Calibrated, Plastic Hub, Fixed Wing, Sterile, Rx only
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-0087-2018·2017-11-15

    Epimed RX-2 COUDE Epidural Needle Recalled for Potential Sterility Seal Defect

    Epimed International is recalling 500 units of RX-2 COUDE Epidural Needles due to a potential incomplete seal that may impact sterility.

    Product
    RX-2 COUDE Epidural Needle, 16g x 3.5in (8.9cm)TW, 10 units, Calibrated, Plastic Hub, Detachable Wing, Blunt Stylet, Sterile, Rx only, For Use with 19g or Smaller Catheter
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-0088-2018·2017-11-15

    Epimed COUDE Blunt Nerve Block Needle Recall for Sterility Concerns

    Epimed International is recalling COUDE Blunt Nerve Block Needles due to a potential seal defect that may compromise sterility.

    Product
    COUDE Blunt Nerve Block Needle, 10 units, 0.71mm (22 Ga) x 152mm, Each Unit Contains One Blunt Nerve Block Needle and One Wing, Sterile
    Category
    Medical Device
    Distribution
    13 states