Foam Protective Pouches, model numbers 6010 (50 each/case)… recallZ-3129-2024 · Medical Action Industries, Inc. 306 · initiated Jun 11, 2024
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 Medical Action Industries, Inc. 306 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
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-3129-2024
- Status
- Open, Classified
- Initiated by the company
- Jun 11, 2024
- Posted by the FDA
- Sep 12, 2024
- Recalling firm
- Medical Action Industries, Inc. 306
- Quantity
- 5,981,534 units
- Product code
- FSM
- Distribution
- Nationwide distribution. International distribution to Canada.
Product description
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)
Code information (models, lots, serial 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
Devices named in this recall
13 devices in the FDA device registry whose identifier appears in the recall's code information.
- Medical Action Industries 6010Medical Action Industries Inc. · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- Medical Action Industries 6010-1Medical Action Industries Inc. · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- Medical Action Industries 6060Medical Action Industries Inc. · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- Medical Action Industries 6070Medical Action Industries Inc. · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- Medical Action Industries 6106Medical Action Industries Inc. · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- Medical Action Industries 6141Medical Action Industries Inc. · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- Medical Action Industries 6203Medical Action Industries Inc. · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- Medical Action Industries 6805Medical Action Industries Inc. · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- Medical Action Industries 6805-1Medical Action Industries Inc. · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- Medical Action Industries 6810Medical Action Industries Inc. · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- Medical Action Industries 6810-1Medical Action Industries Inc. · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- Medical Action Industries 6830Medical Action Industries Inc. · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- Medical Action Industries 6860Medical Action Industries Inc. · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
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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