FDA Device recall Z-0089-2018
TUOHY Epidural Needle, 20g x 3.5in(8.9cm) TW, 10 units, Calibrated, Plastic Hub, Fixed Wing, Sterile, Rx only
- FDA Device
- Class II
- terminated
- Published 2017-11-15
On 2017-11-15 the FDA classified a Class II recall of TUOHY Epidural Needle, 20g x 3.5in(8.9cm) TW, 10 units, Calibrated, Plastic Hub, Fixed Wing, Sterile, Rx only by Epimed International, citing potential for partially incomplete seal of product, impacting sterility.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0089-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-07-24 |
| Published | 2017-11-15 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Epimed International |
| Distribution | AR, CA, IA, IN, KY, LA, MI, NY, OH, OR, TN, TX, WA |
Product
TUOHY Epidural Needle, 20g x 3.5in(8.9cm) TW, 10 units, Calibrated, Plastic Hub, Fixed Wing, Sterile, Rx only
Reason
Potential for partially incomplete seal of product, impacting sterility.
Identifiers
| code_info | Lot No. 12358202; Ref No. 125-2035T. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0089-2018%22
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