Z-2007-2026Class I

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

Name: Z-2007-2026 Medical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO, Rx Only, QTY: 5/Case
Creator: Medical Action Industries, Inc. 306
Published: 2026-03-17
License: https://open.fda.gov/license/

Medical Action Industries, Inc. 306 / initiated 2026-03-17 / Open, Classified

FDA source

Medical Action Industries, Inc. 306 began a recall of Medical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO, Rx Only, QTY: 5/Case on 2026-03-17. FDA classified it as Class I and gives the reason as "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"". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2007-2026
Classification: Class I
Status: Open, Classified
Initiated: 2026-03-17
Posted: 2026-05-06
Recalling firm: Medical Action Industries, Inc. 306
Product: Medical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO, Rx Only, QTY: 5/Case
Product code: LRO General Surgery Tray
Reason for recall: 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: Unknown/Undetermined by firm
Action: 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.
Quantity in commerce: 2030 kits
Distribution: US distribution to state of: AZ OUS: None
Product codes and lots: UDI:20809160490294/ Lot numbers: 342509, 346066, 338434, 339423, 337365, 335489, 336189, 336789

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2007-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2007-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-05-13	2026-05-06

Product code LRO

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)