FDA Device recall Z-1747-2022
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: 3…
- FDA Device
- Class II
- ongoing
- Published 2022-09-21
On 2022-09-21 the FDA classified a Class II recall of 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: 3… by Carwild, citing sterility with new cotton source not validated.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1747-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-08-02 |
| Published | 2022-09-21 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Carwild |
| Distribution | US |
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
Sterility with new cotton source not validated
Identifiers
| code_info | UDI-DI: Unit of Use: 00634303020740 Primary: 30634303020741 Lot Number: 22B0428 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1747-2022%22
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