Carwild Corporation 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Carwild Corporation
Lot Codes / Batch Numbers
UDI-DI: Unit of Use: 00634303020740 Primary: 30634303020741 Lot Number: 22B0428
Products Sold
UDI-DI: Unit of Use: 00634303020740 Primary: 30634303020741 Lot Number: 22B0428
Carwild Corporation is recalling FABCO ORS DENTAL ROLLS, 1-1/2" STERILE, COTTON 3/8" Diameter x 1-1/2" (9.5mm x 38.1mm), packaged 5 due to Sterility with new cotton source not validated. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Sterility with new cotton source not validated
Recommended Action
Per FDA guidance
Carwild Corp. issued Recall Urgent Notice via email on 8/2/22 in a pdf form fillable document for Distributors/Direct accounts to complete and return. Letter states reason for recall, health risk and action to take: 1. Discontinue use of this product and Immediately place inventory of this product on HOLD. Distributors to provide traceability of lot. 2. Complete and return the attached RECALL NOTICE to us. 3. Once we receive the completed RECALL NOTICE, we will make arrangements for the product to be returned. Please respond immediately to confirm receipt of this email. Call for questions or additional Regulatory (Voice) information. 1-860-442-4914 x111 Please introduce as inquiry Customer Service related to RECALL NOTICE 1-860-442-4914 x110. PRODUCT RECALL and RESPONSE : regulatory@carwild.net customerservice(@carwild.net
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026