Stryker recalls certain Cardiovascular Reprocessed ViewFlex Xtra ICE Catheters with incorrect expiration dates that may cause sterility breaches or treatment delays. Affected units have a one-year shelf life but are labeled as two years.
A subset of temporary intracardiac ultrasound catheters are labeled with the incorrect expiration date. They are mislabeled as having a shelf life of two years, while the actual shelf life is one year. The earliest affected product will expire in May 2020. Use of mislabeled devices may lead to hazards sterility breach, component breakdown or delay in treatment.
Take action
Contact the company
📍Recalling firmStryker Sustainability Solutions1810 W Drake Dr · Tempe, AZ 85283-4327
“Stryker Cardiovascular Catheters Recalled: Incorrect Expiration Dates Risk Sterility.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65596-stryker-cardiovascular-catheters-recalled-incorrect-expiration-dates-risk-sterility-breach. Based on FDA recall #Z-2113-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2113-2020%22&limit=1).
The FDA announced on March 27, 2020, that Stryker Sustainability Solutions is recalling Cardiovascular Reprocessed ViewFlex Xtra ICE Catheters due to incorrect expiration dates. The hazard involves potential sterility breaches or component breakdown from using expired devices. Owners should check the product labels for affected lot codes.
How to tell if you have it
Brand: Stryker
Product: Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter, REF D087031, OM St. Jude Medical, Size 9F (3.2mm), Length 90 cm
Units affected: 101
The hazard
A subset of temporary intracardiac ultrasound catheters are labeled with an incorrect expiration date, showing a two-year shelf life instead of the actual one year. The earliest affected product will expire in May 2020. Use of these mislabeled devices may lead to hazards sterility breach, component breakdown or delay in treatment.
Context
GovInfoNow's records show Stryker Sustainability Solutions has 22 other recalls on record since December 1, 2017. Other recent recalls of similar products include Stryker XCEL Bladeless Trocar W/Optiview (August 19, 2026), Bard EP XT Decapolar Catheter Recall (August 18, 2026), and Stryker Daig Livewire Steerable BDB Catheter Recall (April 10, 2026). Other recent recalls of similar products include Cook Medical Multipurpose Drainage Catheter Recall (March 5, 2026), Covidien EndoFLIP System (May 13, 2026), and Cook Medical Spectrum Central Venous Catheter Sets (March 5, 2026).
How to tell if you have this one
Check for the product name 'Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter', size 9F (3.2mm), length 90 cm, and the unique identifiers listed in the recall notice. The earliest affected units expire in May 2020.
Brand
Stryker
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Expiration Date
Verify the expiration date on the catheter's packaging or label; if it shows two years instead of one year, it is affected.
Discontinue Use
If the catheter has an incorrect expiration date, stop using it immediately and contact Stryker for further instructions.
Where it went and when
Where it was distributed
Distributed in 16 states.
Listed by the agency
Not listed
FDA distribution: “US: AZ, CA, FL, GA, ID, IL, IN, KS, MA, MO, PA, TN, TX, VA, WA, WV OUS: None” States read from FDA’s own wording; “not listed” means the notice does not name it.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2113-2020 (March 27, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2113-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.