(1) Carefusion V. Mueller Graves Vaginal Speculum, Catalog #GL11,… — Class II medical device recall Z-1421-2023
Ongoing recall by Carefusion 2200 Inc, reported 2023-05-03, distributed in AL, AR, AZ, CA, CO, CT, FL, HI…. A portion of the two products were incorrectly marked (etched) and packaged resulting in a product mismatch. T
| Recall number | Z-1421-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carefusion 2200 Inc, Vernon Hills, IL, United States |
| Recall initiated | 2023-03-16 |
| Classified | 2023-04-21 |
| Reported by FDA | 2023-05-03 |
| Distributed | 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, PR, SC, TN, TX, VA, WA, WI, WV |
| Countries outside the US | CA |
| Quantity | 726 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 10885403042744, 10885403042812 |
| Lot numbers | D22XBB |
| Model numbers | GL11, GL31 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1421-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.