Sterile Dental Rolls Recalled: New Cotton Source Sterility Not Validated
Carwild Corporation is recalling FABCO ORS Dental Rolls because the sterility of a new cotton source was not validated. The recalled 90 cases (4,500 units) with lot 22B0428 were distributed nationwide.
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 is a Class II FDA-regulated medical device where the fundamental safety property—sterility—was not validated for a new material source. Although no illnesses or injuries have been reported, the product poses a theoretical contamination risk to patients in direct contact with the device during dental procedures, qualifying as a risk-of-harm product per rubric guidance.
Plain-English summary
Carwild Corporation is recalling FABCO ORS Dental Rolls, sterile cotton dental rolls used in dental procedures. The recalled product consists of 90 cases containing 4,500 individual units with lot number 22B0428, distributed nationwide in the United States.
The recall was issued because the sterility of a new cotton source used in manufacturing the rolls was not validated prior to distribution.
Dental practitioners and healthcare providers who have received affected rolls from this lot should discontinue use and contact Carwild Corporation for return or replacement instructions.
The recalled product
- 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
- Manufacturer
- Carwild Corporation
- Category
- Medical Device — Dental
- Hazard
- sterility-not-validated
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 (1)
- UDI-DI: Unit of Use: 00634303020740 Primary: 30634303020741 Lot Number: 22B0428
Distribution
Distributed nationwide across the United States.
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