Class 3 Device Recall Kit: Urinary Clean Catch 20/cs

• Date Initiated by Firm: July 09, 2026
• Date Posted: October 02, 2026
• Recall Status: Open, Classified
• Recall Number: Z-0069-2027
• Recall Event ID: 99491
• Product Classification: Urine collection kit (excludes HIV testing) - Product Code OIE
• Product: Generic Name: Kit, Urine, Clean Catch Trade Name: Kit: Urinary Clean Catch 20/cs Model/Catalog Number: 76769 Lot Number: 333606 UDI-DI: 20809160118228 Software Version: N/A
• Code Information: Lot Code: Lot Number: 333606 UDI: 20809160118228 Expiration Date: 3/31/2027
• FEI Number: 1030451
• Recalling Firm/ Manufacturer: Medical Action Industries, Inc. 306; 25 Heywood Rd; Arden NC 28704-9302
• For Additional Information Contact: Marlene Jones; +1-844-4259273
• Manufacturer Reason for Recall: An internal data-entry error caused kit lot 333606 to be labeled with an expiration date of March 31, 2027, instead of February 28, 2027.
• FDA Determined Cause: Labeling design
• Action: On 07/09/2026, an "URGENT: MEDICAL DEVICE FIELD CORRECTION" Letter was emailed to customers informing them that, due to an internal error, item 76769, KIT: Urinary Clean Catch, was inadvertently assigned an incorrect expiration date of 2027/03/31. The correct expiration date is 2027/02/28. Product was distributed between 09/24/2025 to 12/17/2025. On 08/03/2026, an updated "URGENT: MEDICAL DEVICE FIELD CORRECTION" letter was emailed to customer to notify them that, The previous notifications, dated July 9, 2026 and July 24, 2026, contained an incorrect lot number. As stated below, the correct lot number is 76769. Customers were instructed to: 1. Identify and quarantine all impacted product. 2. Add warning labels to impacted product with the new expiration date. A labeling template is enclosed for printing labels which can be affixed on all affected product 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. - Customers (end-users): If you received product from a distributor, contact the distributor or your sales representative with any questions you may have. - 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. 3. Complete the attached Recall Response Form and return by August 21, 2026. For questions - contact Regulator Affairs at 844-425-9273 or email GM-OMRA_RECALLS@owens-minor.com
• Quantity in Commerce: 4000
• Distribution: U.S.: CA O.U.S.: N/A
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.