CLASS III ONGOING Device recall · Reported 14 Oct 2026 · FDA Enforcement Report
Kit: Urinary Clean Catch 20/cs recalled by Medical Action Industries
Medical Action Industries Inc. 306 is recalling Kit: Urinary Clean Catch 20/cs, distributed in California. The recall was initiated on 9 Jul 2026 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0069-2027
- FDA event ID
- 99491
- Recalling firm
- Medical Action Industries Inc. 306, Arden, NC
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 9 Jul 2026
- FDA classified
- 2 Oct 2026
- Reported
- 14 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 9 Jul 2026 | Recall initiated by company | |
| 2 Oct 2026 | Classified by FDA | +85 days |
| 14 Oct 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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
Where it was distributed
U.S.: CA O.U.S.: N/A
Questions about this recall
Why was it 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.
Which lots are affected?
Lot Code: Lot Number: 333606 UDI: 20809160118228 Expiration Date: 3/31/2027
Where was it sold?
U.S.: CA O.U.S.: N/A
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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