Generic Name: Kit, Urine, Clean Catch recallZ-0069-2027 · Medical Action Industries, Inc. 306 · initiated Jul 9, 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
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 root cause category: Labeling design
What the company is doing
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 [email protected]
Recall details
- Recall number
- Z-0069-2027
- Status
- Open, Classified
- Initiated by the company
- Jul 9, 2026
- Posted by the FDA
- Oct 2, 2026
- Recalling firm
- Medical Action Industries, Inc. 306
- Quantity
- 4000
- Product code
- OIE
- Distribution
- U.S.: CA O.U.S.: N/A
Product description
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 (models, lots, serial numbers)
Lot Code: Lot Number: 333606 UDI: 20809160118228 Expiration Date: 3/31/2027
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Medical Action Industries 76769Medical Action Industries Inc. · Urine collection kit (excludes HIV testing)1 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.
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