FABCO ORS DENTAL ROLLS — Class II medical device recall Z-1747-2022
Ongoing recall by Carwild Corporation, reported 2022-09-21, distributed nationwide. Sterility with new cotton source not validated
| Recall number | Z-1747-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carwild Corporation, New London, CT, United States |
| Recall initiated | 2022-08-02 |
| Classified | 2022-09-15 |
| Reported by FDA | 2022-09-21 |
| Distributed | Nationwide (US) |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00634303020740, 30634303020741 |
| Lot numbers | 22B0428 |
Product
FABCO ORS DENTAL ROLLS, 1-1/2" STERILE, COTTON 3/8" Diameter x 1-1/2" (9.5mm x 38.1mm), packaged 5 /Pouch, 50 Pouches/Box Reorder Number: 34911510
Reason for recall
Sterility with new cotton source not validated
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-1747-2022. 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.