Brand Name: Medical Action Industries recallZ-2858-2026 · Medical Action Industries, Inc. 306 · initiated May 21, 2026
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
Convenience kits contain needle free access device that has an improper seal which may result in doming or tearing of the silicone seal.
FDA root cause category: Nonconforming Material/Component
What the company is doing
On May 21, 2026 Medical Action Industries issued a "Urgent: Medical Device" Recall notification via Email. Medical Action Industries asked consignees to take the following actions: 1. Identify, Segregate, and Quarantine all impacted kits listed in Table 1. 2. Add warning labels to affected AVID kits to ensure all users are aware of discarding the impacted component prior to use. 3. A labeling template is enclosed for printing labels which can be affixed on all affected kits and cases in inventory. 4. Customers (end-users): If you have received product from a distributor, please contact the distributor or your sales representative with any questions you may have. 5. Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. 6. Complete the attached Recall Response Form and return by June 5, 2026.
Recall details
- Recall number
- Z-2858-2026
- Status
- Open, Classified
- Initiated by the company
- May 21, 2026
- Posted by the FDA
- Aug 3, 2026
- Recalling firm
- Medical Action Industries, Inc. 306
- Quantity
- 3740 kits (180 cases)
- Product code
- PEV
- Distribution
- US Nationwide distribution in the state of CA.
Product description
Brand Name: Medical Action Industries Product Name: Dialysis Change Tray Clear Sequence Model/Catalog Number: 78791
Code information (models, lots, serial numbers)
Lot Code: Lot No.: 327075 328690 319980 320965 318461 322375 325653 330775 331356 336680 UDI: 20809160242558
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Medical Action Industries 78791Medical Action Industries Inc. · Dialysis administration kit1 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.
How recalls are matched to devices · Editorial policy · Report an error on this page