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Epimed International Recalls
11 recalls on record · November 9, 2016 to August 25, 2021 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 25, 2021Medical DevicesFDA
Epimed International recalls NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile
Hazard: Potential for stylet to protrude from the distal end of the catheter
August 25, 2021Medical DevicesFDA
Epimed International recalls NEO-KATH Epidural Catheter Set, REF 200-2430, Sterile
Hazard: Potential for stylet to protrude from the distal end of the catheter
March 24, 2021Medical DevicesFDA
Epimed International, Inc. recalls Feth-R-Kath Catheter, 19g x 24". Intended Use:Radlo Opaque Epidural Catheter Catalog #: 157-1924 Intended for epidu
Hazard: Outer coating of the catheter may deteriorate and result in the coating to crack and/or potentially flake off
May 13, 2020Medical DevicesFDA
Epimed International recalls R-F Injector Cannula. 20gx10cm-STERILE. REF/UDI: 257-2010/(01)10818788022124; REF/UDI: 257-2010D(01)00818788022127 - Pro
Hazard: Incorrect expiration date on introduction cannula packaging.
May 13, 2020Medical DevicesFDA
Epimed International recalls R-F Injector Cannula. 18gx10cm-STERILE. REF/UDI: 257-1810/(01)00828788021496; REF/UDI: 257-1810D(01)10818788021493 - Pro
Hazard: Incorrect expiration date on introduction cannula packaging.
July 31, 2019Medical DevicesFDA
Epimed International, Inc. recalls 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) 10
Hazard: Mislabeled - The product's labeling contains an incorrect size for the catheter included in the kit. The kit contains a 21 gauge catheter, however the labeling states a 12 gauge catheter is included.
July 31, 2019Medical DevicesFDA
Epimed International, Inc. recalls 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) 10
Hazard: Mislabeled - The product's labeling contains an incorrect size for the catheter included in the kit. The kit contains a 21 gauge catheter, however the labeling states a 12 gauge catheter is included.
November 15, 2017Medical DevicesFDA
Epimed International recalls TUOHY Epidural Needle, 20g x 3.5in(8.9cm) TW, 10 units, Calibrated, Plastic Hub, Fixed Wing, Sterile, Rx only
Hazard: Potential for partially incomplete seal of product, impacting sterility.
November 15, 2017Medical DevicesFDA
Epimed International recalls COUDE Blunt Nerve Block Needle, 10 units, 0.71mm (22 Ga) x 152mm, Each Unit Contains One Blunt Nerve Block Needle and On
Hazard: Potential for partially incomplete seal of product, impacting sterility.
November 15, 2017Medical DevicesFDA
Epimed International recalls RX-2 COUDE Epidural Needle, 16g x 3.5in (8.9cm)TW, 10 units, Calibrated, Plastic Hub, Detachable Wing, Blunt Stylet, Ste
Hazard: Potential for partially incomplete seal of product, impacting sterility.
November 9, 2016Medical DevicesFDA
Epimed International, Inc. recalls 15 g R.K. Epidural Needle (TW), Catalog #/REF #100-1415 Intended for the epidural placement, directly or through an ep
Hazard: There is a possibility that the needles may have the potential to skive a catheters outer coating. If this were to occur, there exists the risk that a portion of the catheter could remain in the patient, which may require otherwise unnecessary medical invention.