UroLift System recalled for potential implant deployment failure
Neotract Inc is recalling 18,722 UroLift Systems due to potential improper implant deployment during use. Patients should contact their healthcare provider.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA recall for a risk-of-harm medical device where deployment failure is a potential complication. No illnesses or injuries are reported in the source material, per the rubric guideline for risk-of-harm products.
Plain-English summary
Neotract Inc is recalling 18,722 UroLift System REF UL400-4 devices distributed across the United States.
The UroLift System is a medical device used for urological implants. There is a potential that during implant deployment, the device may not properly deliver the implant.
Patients who have received one of the affected devices should contact their healthcare provider immediately to discuss their device and determine appropriate next steps. Healthcare providers should review the specific lot numbers and check if their patients received affected units.
The recalled product
- Product
- UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool
- Manufacturer
- Neotract Inc
- Affected units
- 18,722
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI/DI: 00814932020049 & 00814932020001
- 73C2200911
- and 73C2201163
Distribution
Related recalls
Same manufacturer · Neotract Inc
See all →- HighNeotract Recalls UroLift System Due to Capsular Tab Delivery Failure
FDA (Devices) · 2018-12-19
Same hazard · device malfunction
See all →- SevereMedtronic MiniMed Flex Insulin Pumps Recalled for Failed Verification Tests
FDA (Devices) · 2026-10-14
- ModerateWilson-Cook Recalls Hemospray Endoscopic Hemostat Due to Adherence Issues
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Et Control Software Recalled for Anesthetic Delivery Interruption
FDA (Devices) · 2026-09-23
Similar recalls
- HighNeotract Recalls UroLift System Due to Capsular Tab Delivery Failure
FDA (Devices) · 2018-12-19
- HighMedical Device Recall: UroLift Visual Obturator Weld Defect Risk
FDA (Devices) · 2023-08-16
- HighColoplast Ureteral Dilators Recalled Due to Sterile Packaging Issue
FDA (Devices) · 2024-04-10
- HighPhilips UroDiagnost x-ray system recalled due to potential bolt failure
FDA (Devices) · 2016-08-10
- SevereAbbott MitraClip XTR Clip Delivery System Recalled for Malfunction
FDA (Devices) · 2019-06-05
- SeverePhilips UroDiagnost MRF Recall Due to Missing Locking Plate
FDA (Devices) · 2019-04-03