Stryker Recalls XCEL Bladeless Trocar Due to Cracking Risk
Stryker is recalling XCEL Bladeless Trocars because the reusable access port system may crack or separate during use.
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: The recall is classified as FDA Class II, and the hazard involves a structural defect (cracking/separation) in a medical device used during surgery, which presents a risk of harm even without reported injuries.
Plain-English summary
Stryker Sustainability Solutions is recalling the Ethicon Endo-Surgery, Inc. XCEL Bladeless Trocar with Stability Sleeve (12x100mm). The recall involves 2,682 units of the device.
The recall was initiated because the reusable access port system may crack or separate during use. This defect poses a potential risk to patients and healthcare providers during surgical procedures.
The affected devices were distributed nationwide in the United States, including all 50 states, the District of Columbia, and Puerto Rico, as well as in Israel and Canada. Healthcare facilities and distributors should check their inventory for the specific lot numbers listed in the recall notice and stop using the affected devices immediately.
The recalled product
- Product
- REF:B12LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 12X100MM
- Manufacturer
- Stryker Sustainability Solutions
- Affected units
- 2,682
Distribution
Related recalls
Same manufacturer · Stryker Sustainability Solutions
See all →- SevereStryker Bard EP XT Decapolar Steerable Diagnostic EP Catheter Recalled for Sterile Barrier Breach
FDA (Devices) · 2026-10-14
- HighStryker Recalls XCEL Bladeless Trocars Due to Cracking Risk
FDA (Devices) · 2026-09-23
- HighStryker Recalls XCEL Bladeless Trocar Due to Cracking Risk
FDA (Devices) · 2026-09-23
- HighStryker Recalls XCEL Bladeless Trocars Due to Cracking Risk
FDA (Devices) · 2026-09-23
- HighStryker Recalls XCEL Bladeless Trocar Due to Cracking Risk
FDA (Devices) · 2026-09-23
Same hazard · structural failure
See all →- HighC.A.M.P. Recalls Mountain Ice Axes Due to Fall Hazard Risk
CPSC · 2026-11-05
- ModerateZiehm-Orthoscan Recalls 55 Versa Mini C-Arm Systems for Weld Defect
FDA (Devices) · 2026-11-04
- CriticalHarkla Recalls Children's Sensory Swings Due to Fall Hazard
CPSC · 2026-10-29
- SevereBeckman Coulter Centrifuge Rotors Recalled for Structural Defect
FDA (Devices) · 2026-10-28
- Severe
Similar recalls
- HighStryker Recalls XCEL Bladeless Trocars Due to Cracking Risk
FDA (Devices) · 2026-09-23
- HighStryker Recalls XCEL Bladeless Trocar Due to Cracking Risk
FDA (Devices) · 2026-09-23
- HighStryker Recalls Reprocessed Xcel Bladeless Trocars Due to Plug Breakage
FDA (Devices) · 2016-12-21
- ModerateStryker recalls mislabeled 5mm trocar sleeves due to length discrepancy
FDA (Devices) · 2015-09-02
- SevereStryker Recalls Optical Access Systems Due to Fracture Risk
FDA (Devices) · 2015-07-01
- ModerateEthicon Endo-Surgery Recalls 5mm Endopath Xcel Trocars Due to Lubrication Issues
FDA (Devices) · 2018-05-23