Stryker recalls mislabeled 5mm trocar sleeves due to length discrepancy
Stryker Sustainability Solutions is recalling 90 reprocessed trocar sleeves labeled as 100mm but containing 75mm models.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a labeling error (length discrepancy) without reported injuries or illnesses, fitting the Moderate criteria for minor labeling errors or low-risk issues.
Plain-English summary
Stryker Sustainability Solutions is recalling 90 units of reprocessed Ethicon Endo-Surgery, Inc. Excel Trocar Sleeve w/Stability Sleeve, 5mm x 100mm. The recall involves lot number 3574704, which was distributed nationwide to Nevada, New Mexico, Texas, and Michigan.
The recall was initiated after reports indicated that devices from this specific lot were labeled as 100mm models (CB5LT), but the devices inside the packaging were actually 75mm models (CB5ST). This labeling discrepancy creates a risk that healthcare providers may use a device of a different length than intended for a surgical procedure.
Healthcare facilities should stop using the affected devices and contact Stryker Sustainability Solutions for instructions on how to return them. The affected devices are sterile single-patient use devices used to minimize gas leakage during laparoscopic procedures.
The recalled product
- Product
- Stryker Sustainability Solutions CB5LT Ethicon Endo-Surgery, Inc. Excel Trocar Sleeve w/Stability Sleeve 5mm x 100mm Reprocessed by Stryker Sustainability Solutions Product Usage: The Reprocessed Ethicon ENDOPATH¿ XCEL Universal Trocar Stability Sleeve is a sterile si
- Manufacturer
- Stryker Sustainability Solutions
- Hazard
- Affected units
- 90
Distribution
Related recalls
Same manufacturer · Stryker Sustainability Solutions
See all →- HighDaig Livewire Steerable Electrophysiology Catheter Sterile Seal Defect Recall
FDA (Devices) · 2026-05-20
- HighReprocessed electrophysiology catheters recalled over incomplete sterile seals
FDA (Devices) · 2026-05-20
- HighReprocessed Electrophysiology Catheter Recalled for Incomplete Seals
FDA (Devices) · 2026-05-20
- HighDaig Livewire Steerable Electrophysiology Catheters Recalled for Incomplete Seals
FDA (Devices) · 2026-05-20
- HighReprocessed Electrophysiology Catheter Recalled for Incomplete Sterile Seals
FDA (Devices) · 2026-05-20
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02