Carefusion Vaginal Specula Recalled for Incorrect Labeling and Packaging
Carefusion recalled 726 units of two vaginal specula models with labels and laser etchings switched during packaging. This mislabeling could result in use of an unintended product.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II medical device recall involves labeling mismatch between two surgical instruments with different designs, which could result in use of an unintended product. No illnesses or injuries have been reported, but mislabeling of medical devices in clinical settings represents a risk-of-harm situation.
Plain-English summary
Carefusion 2200 Inc has recalled 726 units of two models of vaginal specula: the V. Mueller Graves Vaginal Speculum (Catalog #GL11, Medium, 4 x 1 3/8 inches) and the V. Mueller Pederson Vaginal Speculum (Catalog #GL31, Medium, 4 x 7/8 inches). A portion of these products were incorrectly marked and packaged with switched labels and laser etchings, resulting in product identification mismatches.
The affected units were distributed to hospitals and healthcare facilities across 35 U.S. states, Puerto Rico, Canada, and government/military locations. The affected lot number is D22XBB for both products.
Healthcare providers should verify the product identity of any units on hand through physical inspection and refer to manufacturer documentation. Providers should review patient records to confirm the correct product was used in any procedures. Contact Carefusion 2200 Inc or the FDA to report any concerns or adverse events.
The recalled product
- 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).
- Manufacturer
- Carefusion 2200 Inc
- Hazard
- mislabeling
- product-identification-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot number D22XBB for both products. V. Mueller Graves UDI-DI 10885403042744
- V. Mueller Pederson UDI-DI 10885403042812.
Distribution
Distributed in 35 states:
- 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
- WV
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