Stryker Recalls Mislabeled Intracardiac Ultrasound Catheters Due to Expiration Date Error
Stryker is recalling 101 intracardiac ultrasound catheters labeled with incorrect expiration dates, posing risks of sterility breach or component breakdown.
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 involves a risk-of-harm product (sterility breach, component breakdown) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Stryker Sustainability Solutions is recalling 101 units of Cardiovascular Reprocessed ViewFlex Xtra ICE Catheters (REF D087031) due to a labeling error. The devices are labeled with a shelf life of two years, but the actual shelf life is one year. The earliest affected product will expire in May 2020.
The affected catheters were distributed in Arizona, California, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Massachusetts, Missouri, Pennsylvania, Tennessee, Texas, Virginia, Washington, and West Virginia. No international distribution is reported.
Use of these mislabeled devices may lead to hazards including sterility breach, component breakdown, or delay in treatment. Healthcare providers should stop using the affected units and contact Stryker for instructions on return or replacement.
The recalled product
- Product
- Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter, REF D087031, OM St. Jude Medical, Size 9F (3.2mm), Length 90 cm, Sterile EO, Rx Only, Quantity 1, UDI: 07613327376067
- Manufacturer
- Stryker Sustainability Solutions
- Affected units
- 101
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 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
- HighStryker Recalls XCEL Bladeless Trocars Due to Cracking Risk
FDA (Devices) · 2026-09-23
Same hazard · sterility breach
See all →- HighMedline Open Heart A Pack Kits Recalled for Sterility Concerns
FDA (Devices) · 2026-09-23
- HighAVID Medical Recalls Halyard IV Start Kits Due to Seal Defects
FDA (Devices) · 2026-09-16
- HighMedline Convenience Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- SevereMedline C-Section Prep Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- SevereMedline Ultrasound Breast Pack Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
Similar recalls
- ModerateStryker Recalls Mislabeled Reprocessed Diagnostic Electrophysiology Catheters
FDA (Devices) · 2016-06-01
- ModerateStryker Neurovascular Microcatheters Recalled for Incorrect Use-By Dates
FDA (Devices) · 2013-12-25
- HighStryker Recalls Reprocessed Electrophysiology Catheter Cables Due to Sterility Breach
FDA (Devices) · 2017-01-18
- HighReprocessed Electrophysiology Catheter Recall Due to Incomplete Seals
FDA (Devices) · 2026-05-20
- ModerateStryker Neurovascular Microcatheters Recalled for Shelf-Labeling Errors
FDA (Devices) · 2013-12-25
- ModerateStryker Neurovascular Microcatheters Recalled for Shelf-Life Labeling Errors
FDA (Devices) · 2013-12-25