Z-3129-2024Class II

Foam Protective Pouches, model numbers 6010 (50 each/case), 6010-1 (350 each /case), 6060 (8 rolls/case)...

Name: Z-3129-2024 Foam Protective Pouches, model numbers 6010 (50 each/case), 6010-1 (350 each /case), 6060 (8 rolls/case)...
Creator: Medical Action Industries, Inc. 306
Published: 2024-06-11
License: https://open.fda.gov/license/

Medical Action Industries, Inc. 306 / initiated 2024-06-11 / Open, Classified / root cause: labeling and UDI

FDA source

Medical Action Industries, Inc. 306 began a recall of 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... on 2024-06-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-3129-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-06-11
Posted: 2024-09-12
Recalling firm: Medical Action Industries, Inc. 306
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)
Product code: FSM Tray, Surgical, Instrument
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 5,981,534 units
Distribution: Nationwide distribution. International distribution to Canada.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3129-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3129-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-12

Product code FSM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)