5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 75mm sha...
FDA Device Recall #Z-1886-2018 — Class II — March 26, 2018
Recall Summary
| Recall Number | Z-1886-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 26, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Ethicon Endo-Surgery Inc |
| Location | Blue Ash, OH |
| Product Type | Devices |
| Quantity | 14873 |
Product Description
5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 75mm shaft length, 2B5ST
Reason for Recall
Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition, insufficient lubrication could result in a remote chance of introducing a minute particle if repeated insertions of the obturator or laparoscopic device damage the seal.
Distribution Pattern
Nationwide domestic distribution, including PR. International distribution to Saudi Arabia, United Arab Emirates, Belgium, Singapore, Taiwan, South Korea, Canada, Chile, Mexico, Japan, and Argentina.
Lot / Code Information
Lots P4T745 P4T88Y P4T906 P4T91H P4TA60 P4TC8M P4TD0G P4TD2K R40015 R4011E R4025E R4035E R4042Z R4047X R4065E
Other Recalls from Ethicon Endo-Surgery Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0147-2026 | Class II | ECHELON LINEAR Cutters Reload 80 mm Blue, inten... | Sep 11, 2025 |
| Z-1746-2025 | Class I | Endopath Echelon Vascular White Reload for Adva... | Apr 22, 2025 |
| Z-0834-2024 | Class II | ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SUR... | Dec 11, 2023 |
| Z-2355-2021 | Class II | HARMONIC HD 1000i Shears (20cm Shaft Length)-in... | Jul 20, 2021 |
| Z-2356-2021 | Class II | HARMONICHD 1000i Shears (36cm Shaft Length)-ind... | Jul 20, 2021 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.