Envisiontec US Llc PCA 4000 Curing Units, SKU number ACC-06-1000 The PCA 4000 is used for curing industrial resins as well and this recall will not impact units sold to industrial customers. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
PCA 4000 Curing Units, SKU number ACC-06-1000 The PCA 4000 is used for curing industrial resins as well and this recall will not impact units sold to industrial customers.
Brand
Envisiontec US Llc
Lot Codes / Batch Numbers
All units SKU number ACC-06-1000
Products Sold
All units SKU number ACC-06-1000
Envisiontec US Llc is recalling PCA 4000 Curing Units, SKU number ACC-06-1000 The PCA 4000 is used for curing industrial resins as due to The PCA 4000 may not fully cure EnvisionTEC dental resins to desired product specifications.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The PCA 4000 may not fully cure EnvisionTEC dental resins to desired product specifications.
Recommended Action
Per FDA guidance
The firm, Evisiontec US LLC., sent "URGENT: PRODUCT RECALL" notification letters dated 1/20/22 to customers. ACTION: 1. Stop utilizing the PCA 4000 to print medical devices made from EnvisionTec dental resins. 2. Please carry out a physical count and record this data on the Recall Response Form included with this letter. 3. Submit the Recall Response Form by e-mail: envisiontec4279@sedgwick.com or fax to: 866-875-0545 even if you do not have the recalled product. 4. Contact EnvisionTec customer service at envisiontec.com/support to arrange for the return and replacement of the recalled product. This recall is being carried out only for the specific products identified above; no other products are involved in this recall. Notifications of this recall are being sent to all accounts to whom EnvisionToc shipped a recalled product. For customers that redistribute this product to other accounts, please notify your accounts. For questions about the recall process please contact Sedgwick at 1-866-512-4073. For other inquiries regarding these products and to initiate your return, please contact Envision Tac customer service at envisiontec.com/support (if you do not have access to the Internet, contact Sedgwick at the toll-free number above with your contact information and EnvisionTec customer service will promptly contact you to arrange your return). A replacement curing unit of equal or greater value will be provided to customers; if replacement is not available, a credit will be issued to customers at the price in effect at the time of purchase.
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