# FDA recall Z-1421-2023

> **Carefusion 2200 Inc** · Class II · device recall initiated 2023-03-16.

## Product

(1) Carefusion V. Mueller Graves Vaginal Speculum, Catalog #GL11, Medium Blade, 4 x 1 3/8" (10.2 X 3.5cm); and (2) Carefusion V. Mueller Pederson Vaginal Specula, Catalog #GL31, Medium, 4 x 7/8" (10.2 x 2.2cm).

## Reason for recall

A portion of the two products were incorrectly marked (etched) and packaged resulting in a product mismatch.  The labels and laser etchings were switched on the two products.

## Distribution

Distribution was made to AL, AR, AZ, CA, CO, CT, FL, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, VA, WA, WI, and WV, including Puerto Rico.   There was also government/military distribution.   Foreign distribution was made to Canada.

## Key facts

- **Recall number:** Z-1421-2023
- **Recalling firm:** Carefusion 2200 Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-03-16
- **Report date:** 2023-05-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Vernon Hills, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1421-2023

## Citation

> AI Analytics. FDA recall Z-1421-2023. Retrieved 2026-09-09 from https://api.ai-analytics.org/recall/Z-1421-2023. Source: US FDA. Licensed CC0.

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