# FDA recall Z-0166-2022

> **W L Gore & Associates, Inc.** · Class II · device recall initiated 2021-09-02.

## 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 for recall

Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.

## Distribution

US:  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  OUS: AUS, AUT, CAN, CHE, DEU, DNK, ESP, FRA, GBR, GRC, IRL, ITA, MEX, NLD, NOR, PRT, SAU, SWE

## Key facts

- **Recall number:** Z-0166-2022
- **Recalling firm:** W L Gore & Associates, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-09-02
- **Report date:** 2021-11-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Flagstaff, AZ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0166-2022

## Citation

> AI Analytics. FDA recall Z-0166-2022. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/Z-0166-2022. Source: US FDA. Licensed CC0.

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