Lower risk Medical device recall · FDA · Published March 16, 2023

Carefusion Vaginal Specula Recalled Due to Label Mismatch

Carefusion recalls two vaginal specula models (GL11 and GL31) with incorrect labeling causing product mix-ups. Affected units have specific lot numbers and sizes. Consumers should check their specula for label errors.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1421-2023Medical device Carefusion ›

Lower-risk 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.

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Contact the company

Recalling firmCarefusion 2200 Inc75 N Fairway Dr · Vernon Hills, IL 60061-1845

✎ GovInfoNow plain-language explainer

Carefusion is recalling two vaginal specula models due to incorrect labeling that could cause product mix-ups. This mismatch might lead to using the wrong speculum size or type, which could affect medical procedures. Read more at govinfonow.com/recall/58753-carefusion-vaginal-specula-recalled-due-to-label-mismatch.

Source Summary by GovInfoNow · govinfonow.com/recall/58753-carefusion-vaginal-specula-recalled-due-to-label-mismatch · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1421-2023

Cite this page

“Carefusion Vaginal Specula Recalled Due to Label Mismatch.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58753-carefusion-vaginal-specula-recalled-due-to-label-mismatch. Based on FDA recall #Z-1421-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1421-2023%22&limit=1).

The FDA announced on March 16, 2023, that Carefusion 2200 Inc is recalling V. Mueller Graves and Pederson vaginal speculums due to a product mismatch caused by switched labels and laser etchings. The agency issued recall number Z-1421-2023 for the Class II voluntary recall.

How to tell if you have it

Brand: Carefusion
Product: V. Mueller Graves Vaginal Speculum, Catalog #GL11, Medium Blade, 4 x 1 3/8" (10.2 X 3.5cm)
Product: V. Mueller Pederson Vaginal Specula, Catalog #GL31, Medium, 4 x 7/8" (10.2 x 2.2cm)
Lot number: D22XBB
V. Mueller Graves UDI-DI: 10885403042744
V. Mueller Pederson UDI-DI: 10885403042812
Units affected: 726

The hazard

A portion of the recalled products were incorrectly marked and packaged, resulting in a product mismatch where labels and laser etchings were switched between the two items. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Carefusion 2200 Inc has 8 other recalls on record since December 20, 2013. Other recent recalls of similar products include W L Gore GORE VIABIL Short Wire Biliary Endoprosthesis Recall (May 22, 2026), Medline Surgical Gowns Recall (January 7, 2026), and Medline GYN/Laparoscopy CDS Products Recall (January 7, 2026).

How to tell if you have this one

Check your speculum for the label and laser etching: Graves specula should have a 1 3/8" blade size (10.2 x 3.5cm) and Pederson should have a 7/8" blade (10.2 x 2.2cm). Lot number D22XBB applies to both products.

Brand
Carefusion
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Speculum Labels
Look for the blade size and lot number on your speculum to confirm it matches the correct model.

Where it went and when

Where it was distributed

Distributed in 35 states and Puerto Rico, and outside the U.S.

FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Hawaii, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 48 days after the firm started it.

Mar 16, 2023Firm started the recall
Apr 21, 2023FDA classified it Class II
May 3, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/58753-carefusion-vaginal-specula-recalled-due-to-label-mismatch">Carefusion Vaginal Specula Recalled Due to Label Mismatch (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1421-2023 (March 16, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1421-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.