# FDA recall Z-1351-2023

> **Outset Medical, Inc.** · Class II · device recall initiated 2023-01-24.

## Product

Outset Tablo    Model Numbers (REF):  PN-0006000  PN-0007001    Tablo is a next generation, self-contained hemodialysis system (Hemodialysis System or System), intended for acute, home and chronic dialysis therapy with or without ultrafiltration, in an acute or chronic care facility.

## Reason for recall

An observed trend of high conductivity dialysate alarms in a hemodialysis system as a result of introducing a software tool into the manufacturing process.

## Distribution

U.S. Nationwide distribution including in the states of AK, AL, AR, CA, CO, FL, GA, HI, IA, ID, IL, IN, MI, MS, MO, MT, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VT, VA, and WI.  O.U.S.: Not provided.

## Key facts

- **Recall number:** Z-1351-2023
- **Recalling firm:** Outset Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-01-24
- **Report date:** 2023-04-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Jose, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1351-2023

## Citation

> AI Analytics. FDA recall Z-1351-2023. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1351-2023. Source: US FDA. Licensed CC0.

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