Coltene Whaledent Inc Strauss 25 Carbide Dental Burs (100057XXV) Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Strauss 25 Carbide Dental Burs (100057XXV)
Brand
Coltene Whaledent Inc
Lot Codes / Batch Numbers
J77147 J93636
Products Sold
J77147 J93636
Coltene Whaledent Inc is recalling Strauss 25 Carbide Dental Burs (100057XXV) due to The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
Recommended Action
Per FDA guidance
On October 20, 2020, the firm emailed Urgent Medical Device Recall letters to affected distributors. Customers were informed that the incorrect dental carbide bur was manufactured and subsequently packaged and distributed. Customers were asked to return the product to Coltene/Whaledent, Inc. by following the instructions in the letter. The firm will replace the product at no cost. Please inform the firm if you have already used the product. Distributors were asked to either identify and notify their customers who were shipped the affected product or to provide a list of affected customers to the recalling firm so that Coltene/Whaledent, Inc. could notify them.
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 noticeDistribution
As reported by FDA
FL, IN, NV, PA, TN, TX
Page updated: Jan 10, 2026