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Medical Action Industries Inc recallZ-2007-2026 · Medical Action Industries, Inc. 306 · initiated Mar 17, 2026

Open, Classified

Is my device affected?

  1. 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.
  2. 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.
  3. 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 kit contains a syringe in which the rotating adapter may unwind during use, resulting in a loose connection and/or full disconnection between the syringe and manifold"

FDA root cause category: Unknown/Undetermined by firm

What the company is doing

On April 22, 2026, Medial Action Industries, Inc. (subsidiary of Owens & Minor) issued a "Urgent: Medical Device Recall Notification Update" via E-Mail to affected consignees. The updated notification provided clarity and and additional information for the recall strategy. Initial notification was issued on March 17, 2026. Medical Action Industries asked consignees to take the following actions: 1. Identify, segregate, and quarantine all impacted product. Convenience kits can still be used once properly labeled. 2. Add warning labels to affected Medical Action kits to ensure all users are aware of the actions below and identified in the Medline recall notice. A labeling template is enclosed for printing labels which can be affixed on all affected kits and cases in inventory. Please contact your Sales Representative if pre-printed labels are needed. 3. If your firm used the labeling template provided with the initial letter, please adhere the revised label over the existing template label. This label should be applied in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling. 3. Customers (end-users): If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have. 4. 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. 5. Complete the attached Recall Response Form and return by April 30, 2026. If you have any questions, contact Reg. Affairs Manager, Kitting, Global Products, by email: [email protected] or 470-280-4277.

Recall details

Recall number
Z-2007-2026
Status
Open, Classified
Initiated by the company
Mar 17, 2026
Posted by the FDA
May 6, 2026
Recalling firm
Medical Action Industries, Inc. 306
Quantity
2030 kits
Product code
LRO
Distribution
US distribution to state of: AZ OUS: None

Product description

Medical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO, Rx Only, QTY: 5/Case

Code information (models, lots, serial numbers)

UDI:20809160490294/ Lot numbers: 342509, 346066, 338434, 339423, 337365, 335489, 336189, 336789

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page