Henry Schein Masks (AMD Medicom) – production equipment problem (2023)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
HENRY SCHEIN CRITERION ANTI-FOG EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-3281)
Brand
AMD Medicom Inc. 2555 Ch de L'Aviation Montreal Canada
Lot Codes / Batch Numbers
Item Code: 570-3281, UDI DI: 10304040168629, Lot #s: 2340, 2341, 2342
Products Sold
Item Code: 570-3281; UDI DI: 10304040168629; Lot #s: 2340, 2341, 2342;
AMD Medicom Inc. 2555 Ch de L'Aviation Montreal Canada is recalling HENRY SCHEIN CRITERION ANTI-FOG EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-3281) due to Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the product. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
Recommended Action
Per FDA guidance
Urgent Medical Device Recall notification letters dated 12/21/2023 were sent to customers. AMD Medicom requests that you discontinue distribution/use of and return all products from the catalog/lot number referenced above, for a credit. Our records indicate that you have purchased one or more of the referenced products for re-sale to your customers. You should complete the attached Acknowledgment Form for inventory you have received and/or which is still in stock. AMD Medicom requests that you complete and return the Acknowledgment Form enclosed with this letter, even if you do not have the above-mentioned lot numbers in your inventory, within three (3) working days. In addition, please contact your affected customer base, advise them of the recall and provide them with a copy of this letter. You should insert your contact information, email and fax numbers in the Acknowledgement Form and request that they return the Acknowledgment Form to you. Please have them return any unused inventory to you for reconciliation. Once you have received all inventory from your customers, please contact Medicom customer service at 1-800-308-6589 or claims@medicom.ca to receive a Sales Return Order number to identify your shipment of returns. Please return all units of the affected lots (unsold inventory and returns) to: AMD Medicom Inc. 6054 Shook Road, Suite 200 Lockbourne, OH USA 43137 ATTN: Recall. You may use the following courier information: UPS Account# 1149-6837-4.
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