Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Stryker Recalled by Stryker Corporation Due to Potential diff. in the length of the sheath...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Stryker Corporation directly.
Affected Products
Stryker, REF: 0250070460, 5.0 mm x 32 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Sterile, CE, UDI: (01) 07613327051971 These products are distributed with the following sheath/probe: 0250070441-PKG, StrykeFlow Electrocautery Probe, Spatula Tip 5MM 0250070442-PKG, StrykeFlow Electrocautery Probe, J Tip, 5MM 0250070443-PKG, StrykeFlow Electrocautery Probe, L Tip, 5MM 0250070444-PKG, StrykeFlow Electrocautery Probe, Ball Tip, 5MM 0250070445-PKG, StrykeFlow Electrocautery Probe, Needle Tip 5MM 0250070446-PKG, StrykeFlow Electrocautery Probe, Spoon Tip, 5MM
Quantity: 525 devices
Why Was This Recalled?
Potential diff. in the length of the sheath tube and the sheath/probe. A diff. in length could lead to the base of the sheath/probe not being fully seated in the sheath tube which could result in the distal tip of the sheath melting. This could lead to a compromised insulation, leading to unintentional flow of electricity to the patient. The sheath/probe is packaged separately.
Where Was This Sold?
OUS: Netherlands, Spain, Switzerland, Colombia, Canada, Japan, Taiwan,, Puerto Rico, South Africa, and South Korea
About Stryker Corporation
Stryker Corporation has 108 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report