Criterion recallZ-1147-2024 · AMD Medicom Inc. · initiated Dec 21, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from AMD Medicom Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
FDA root cause category: Under Investigation by firm
What the company is doing
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 [email protected] 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.
Recall details
- Recall number
- Z-1147-2024
- Status
- Open, Classified
- Initiated by the company
- Dec 21, 2023
- Posted by the FDA
- Feb 16, 2024
- Recalling firm
- AMD Medicom Inc.
- Quantity
- 960 cases (10 boxes/case and 50 masks/box)
- Product code
- FXX
- FDA submissions
- K051291
- Distribution
- US Nationwide distribution in the states of FL, IA, IN, PA, NV, TX.
Product description
HENRY SCHEIN CRITERION ANTI-FOG EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-3281)
Code information (models, lots, serial numbers)
Item Code: 570-3281; UDI DI: 10304040168629; Lot #s: 2340, 2341, 2342;
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Criterion 5703281Henry Schein, Inc. · Mask, surgical1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 93818).
- Z-1146-2024 · Open, ClassifiedHENRY SCHEIN CRITERION EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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