Stryker Recalls Wound Drains for Potential Sterility Breach
Stryker Instruments is voluntarily recalling CBCII Wound Drains and Ambulating Bulbs due to a potential sterility breach in the packaging.
What this means for you
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 potential sterility breach in a medical device used for wound drainage, which poses a risk of infection or harm to patients. No specific injuries or illnesses are reported in the source text, placing it in the High severity category for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Stryker Instruments Division of Stryker Corporation is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb. The recall is being conducted because of a potential sterility breach in the packaging of these medical devices.
The affected products include the 1/8 in. Trocar with Single Drain, Curved Trocar with Wound Drain, and Double Trocar with Wound Drain. These devices consist of curved metal trocars attached to flexible wound drain tubes, equipped with polymeric trocar guards for protection during handling. The recall covers 6,424 boxes, containing a total of 64,240 individual units.
The products were distributed worldwide, including in the United States, Australia, Great Britain, The Netherlands, Spain, Romania, Greece, Switzerland, South Africa, and Japan. Healthcare providers and facilities should stop using these devices and contact Stryker Instruments for instructions on how to return or dispose of the affected stock.
The recalled product
- Product
- 1/8 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from th
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Stryker Instruments Div. of Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 12 products in this recall →Related recalls
Same manufacturer · Stryker Instruments Div. of Stryker Corporation
See all →- HighStryker Triton Canister Scanning Labels Recalled Due to Color Variance
FDA (Devices) · 2022-07-27
- ModerateTriton Sponge System Software Instructions Updated for Proper Sponge Handling
FDA (Devices) · 2022-07-27
- HighSurgiCount+ System software error bypasses sponge tracking alerts
FDA (Devices) · 2022-07-27
- SevereStryker Recalls Cranial Perforators Due to Potential Metal Fragment Risk
FDA (Devices) · 2020-11-18
- ModerateStryker Neptune E-SEP Blade Electrode Recalled for Expired Product
FDA (Devices) · 2020-05-06
Same hazard · sterility breach
See all →- ModerateMedline Kits with Zimmer Biomet Mixing Bowls and Spatulas Recalled
FDA (Devices) · 2026-07-22
- ModerateMedline Kits with Zimmer Biomet Mixing Bowls Recalled for Seal Defects
FDA (Devices) · 2026-07-22
- HighIntracept Access Instruments sterile barrier breach risk
FDA (Devices) · 2026-07-15
- ModerateSterile Tourniquet Hoses recalled for potential sterility breach
FDA (Devices) · 2026-07-08
- ModerateSterile Tourniquet Hoses Recalled Due to Potential Sterility Breach
FDA (Devices) · 2026-07-08