# FDA recall Z-1946-2026

> **Zimmer, Inc.** · Class II · device recall initiated 2026-03-30.

## Product

Brand Name: Disposable Mixing Bowls with Spatula  Product Name: Mixing Bowl and Spatula  Model/Catalog Number: 00-5049-011-00  Software Version: N/A  Product Description: Mixing Bowl and Spatula  Component: N/A

## Reason for recall

Ten complaints have been received identifying issues at the time of use related to the package seal,  including incomplete seals, wrinkles in the seals or peeling seals. Compromised sterile barrier may lead to clinically insignificant extension of surgery or infection leading to surgical intervention.

## Distribution

US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MD, MI, MO, MS, NC, NE, NM, NY, OH, OK, PA, SD, TN, TX, UT, WA, WI and the countries of Canada, Australia, New Zealand, Malaysia, EMEA, Chile.

## Key facts

- **Recall number:** Z-1946-2026
- **Recalling firm:** Zimmer, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-03-30
- **Report date:** 2026-05-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Warsaw, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1946-2026

## Citation

> AI Analytics. FDA recall Z-1946-2026. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1946-2026. Source: US FDA. Licensed CC0.

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