Kit: Single Shot Epidural 20/Cs, REF: 59553 recallZ-3107-2026 · Medical Action Industries, Inc. 306 · initiated Jul 23, 2026

Why it was recalled

Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility.

FDA root cause category: Nonconforming Material/Component

What the company is doing

On 7/23/2026, "Urgent: Medical Device Recall" notices were emailed to customers who were asked to do the following: 1) Identify, Segregate, and Quarantine all impacted kits. 2) Add warning labels to affected kits to ensure all users are aware of the actions to take prior to use. A labeling template is enclosed for printing labels which can be affixed on all affected kits and cases in inventory. 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. If pre-printed labels are needed, please contact your sales representative. 3) REMOVE AND DISCARD the Sodium Chloride, 0.9%, USP 10 mL Flush ampules prior to use. 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 and return the Recall Response Form via email to [email protected] Report any quality problems or adverse events associated with the products listed in this notification to [email protected] If you have any questions, contact Regulatory Affairs Manager at email: [email protected].

Recall details

Recall number

Z-3107-2026

Status

Open, Classified

Initiated by the company

Jul 23, 2026

Posted by the FDA

Sep 9, 2026

Recalling firm

Medical Action Industries, Inc. 306

Quantity

3,606

Product code

OFT

Distribution

US distribution to states of: IA, VA, MO, KS, FL, OH and LS.

Product description

Kit: Single Shot Epidural 20/Cs, REF: 59553; Kit: Single Shot Epidural 20/Cs, REF: 83945B. Containing Sodium Chloride Injection, 0.9%, USP 10ml ampules

Devices named in this recall

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

• Medical Action Industries 59553

  Medical Action Industries Inc. · Spinal epidural anesthesia kit
  1 recall0 reports
• Medical Action Industries 83945B

  Medical Action Industries Inc. · Spinal epidural anesthesia kit
  1 recall0 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 99613).

• Z-3106-2026 · Open, Classified
  Kit: Epidural/Pain TQC 20/Cs, REF: 82465 Containing Sodium Chloride Injection, 0.9%, USP 10ml ampules