FDA Device recall Z-0166-2022
REF/Catalogue Number GSX0025A, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERI…
- FDA Device
- Class II
- ongoing
- Published 2021-11-03
On 2021-11-03 the FDA classified a Class II recall of REF/Catalogue Number GSX0025A, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERI… by W L Gore And Associates, citing septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0166-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-09-02 |
| Published | 2021-11-03 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | W L Gore And Associates |
| Distribution | AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV |
Product
REF/Catalogue Number GSX0025A, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631025 *Not distributed within the US
Reason
Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
Identifiers
| code_info | serial numbers 22689696 through 23569078 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0166-2022%22
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