CLASS II ONGOING Device recall · Reported 14 Oct 2026 · FDA Enforcement Report
Urology Major kits recalled by Avid Medical
Avid Medical is recalling Urology Major kits, distributed nationwide in the US. The recall was initiated on 10 Aug 2026 and the FDA has classified it as Class II.
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-0103-2027
- FDA event ID
- 99808
- Recalling firm
- Avid Medical, Toano, VA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Aug 2026
- FDA classified
- 7 Oct 2026
- Reported
- 14 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 10 Aug 2026 | Recall initiated by company | |
| 7 Oct 2026 | Classified by FDA | +58 days |
| 14 Oct 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product may be potentially contaminated with a lubricant used during the manufacturing process.
Product as listed by the FDA
UROLOGY MAJOR; Model/Item Number (Kit): WRNM058-10;
Where it was distributed
US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.
Questions about this recall
Why was it recalled?
Product may be potentially contaminated with a lubricant used during the manufacturing process.
Which lots are affected?
Model/Item Number (Kit): WRNM058-10; UDI-DI: 10809160488898; Kit Lot Numbers: 1681989; Recalled Supplier Component (in kit): A902416; Recalled Supplier Lot Number (in kit): NGKU2887;
Where was it sold?
US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
Other products in this recall event
14 other products · FDA event 99808This product is part of a recall event; the main page for the event is Robotic Prostatectomy Pack kits recalled by Avid Medical.
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All 13,908| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Plastics Tray kits recalled by Avid Medical | Avid Medical | Foreign Material | Nationwide |
| Device | CLASS II | Heart Prep Tray kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Pack Open Heart Cfh kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Sperm Ab Elisa (96 well plate test) recalled by DRG International | DRG International | Other | Nationwide |
| Device | CLASS III | BeneView Series recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |