Foam Protective Pouches (Medical Action) - Labeling Error (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Foam Protective Pouches, model numbers 6010 (50 each/case), 6010-1 (350 each /case), 6060 (8 rolls/case), 6070 (75 each/case), 6106 (250 each/case), 6141 (250 each/case), 6203 (40 each/case), 6805 (50 each/case), 6805-1 (175 each/case), 6810 (50 each/case), 6810-1 (350 each/case), 6830 (8 rolls/case), and 6860 (8 rolls/case)
Brand
Medical Action Industries, Inc.
Lot Codes / Batch Numbers
Model Number (UDI-DI Number): 6010 (20809160011253), 6010-1 (20809160011260), 6060 (20809160012090), 6070 (20809160011284), 6106 (20809160011314), 6141 (20809160011369), 6203 (20809160011741), 6805 (20809160011871), 6805-1 (20809160012069), 6810 (20809160012076), 6810-1 (20809160012083), 6830 (20809160012267), 6860 (20809160012564). All lots
Products Sold
Model Number (UDI-DI Number): 6010 (20809160011253), 6010-1 (20809160011260), 6060 (20809160012090), 6070 (20809160011284), 6106 (20809160011314), 6141 (20809160011369), 6203 (20809160011741), 6805 (20809160011871), 6805-1 (20809160012069), 6810 (20809160012076), 6810-1 (20809160012083), 6830 (20809160012267), 6860 (20809160012564). All lots
Medical Action Industries, Inc. is recalling Foam Protective Pouches, model numbers 6010 (50 each/case), 6010-1 (350 each /case), 6060 (8 rolls/c due to The protective pouches were identified to have been improperly labeled with UDI that is associated with an incorrect GMDN (Global Medical Device Nomen. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The protective pouches were identified to have been improperly labeled with UDI that is associated with an incorrect GMDN (Global Medical Device Nomenclature) code. These blue foam pouches were misused due to misclassification of the GMDN.
Recommended Action
Per FDA guidance
Medical Action Industries notified consignees on 06/11/2024 via mail and email. Consignees were instructed to identify and quarantine any affected units in inventory, destroy all affected product, notify any customers if product was further distributed, and to complete and return the response form.
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