Stryker Orthobiologics Recalls Vita Plasma Separator Components
Stryker Orthobiologics is recalling 3,268 units of the Vita Plasma Separator due to a risk of blood displacement during use.
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 risk of harm (blood displacement) in a medical device where specific injury reports are not detailed in the source text.
Plain-English summary
Stryker Orthobiologics, Inc. is recalling 3,268 units of the Vita Plasma Separator, a sterile, single-use component of the Vitagel Surgical Hemostat. The device is designed to prepare plasma from a patient's blood using a tabletop centrifuge. The recall covers part number 2113-0013 and lot numbers T1203002, T1204005, and T1206001.
The recall was initiated after reports indicated that a small amount of blood could collect in the bottom of the centrifuge cup following the centrifugation step. The firm discovered that if blood is present in the Luer connection of the VitaPrep following the blood draw step, this blood could be displaced to the outside of the syringe when the VitaPrep cap is reattached.
The affected units were distributed nationwide, including in Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin, and West Virginia. Healthcare providers should stop using the affected devices and contact Stryker Orthobiologics for instructions on return or replacement.
The recalled product
- Product
- Styker Orthobiologics Vita Plasma Separator, a component of Vitagel Surgical Hemostat. Sterile, single use device designed to prepare plasma from the patient's blood using a tabletop centrifuge.
- Manufacturer
- Stryker Orthobiologics, Inc.
- Affected units
- 3,268
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 (4)
- Part number 2113-0013
- lot numbers T1203002
- T1204005
- and T1206001.
Distribution
Related recalls
Other medical device recalls
- HighMedline C-Section Convenience Kits Recalled for Contaminated Components
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighMedline Recalls Neonatal Heated Wire Breathing Circuits Due to Thermal Damage
FDA (Devices) · 2026-09-02
- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighMedline Recalls 419 Surgical Kits Due to Contaminated Component
FDA (Devices) · 2026-09-02