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.
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.
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.
The labels and laser etchings were switched on the two products, causing a mismatch between the speculum's intended use and its actual size. This could lead to using the wrong type of speculum during medical procedures.
Women who own Carefusion Graves or Pederson vaginal specula with lot number D22XBB are affected. Medical professionals using these specula for gynecological exams are most at risk.
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.
Look for the blade size and lot number on your speculum to confirm it matches the correct model.
The labels and laser etchings were switched on the two products, causing a mismatch between the speculum's intended use and its actual size.
Check your speculum's label and lot number to confirm it matches the recalled models. If it does, contact Carefusion for guidance.
The recall is for product mix-ups, not a direct injury risk. However, using the wrong speculum could affect medical procedures.
We’ve drafted a message you can send Carefusion to request your refund or repair — edit it as you like.
Subject: Recall Z-1421-2023 — Carefusion Carefusion Hello, I own a Carefusion that is covered by recall Z-1421-2023 from Carefusion. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
