FDA Medical Device Recalls (openFDA)
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 number
- Z-1747-2022
- Recalling firm
- Carwild Corporation
- 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
- Status
- Open, Classified
- Initiated
- 2022-08-02
- Posted
- not on file
- Terminated
- not on file
- Reason
- Sterility with new cotton source not validated
- Root cause
- Component change control
- Action
- 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
- Quantity
- 90 CASES (4500 EACHES)
- Distribution
- US Nationwide
- Lot, serial or model codes
- UDI-DI: Unit of Use: 00634303020740 Primary: 30634303020741 Lot Number: 22B0428
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- EFN
- Firm FEI
- 1219313
- Firm city
- New London
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28