Stryker Strykeprobe Outer Sheath Recalled for Potential Electrical Hazard
Stryker is recalling 525 Strykeprobe Outer Sheath Replacement devices due to a potential length mismatch that could cause sheath melting and unintended electrical flow to patients.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of unintentional electrical flow to patients, which constitutes a significant injury risk.
Plain-English summary
Stryker Corporation is recalling 525 units of the Strykeprobe Outer Sheath Replacement (REF: 0250070460). The recall involves a potential difference in length between the sheath tube and the sheath/probe. This mismatch could prevent the base of the sheath/probe from being fully seated in the sheath tube, potentially resulting in the distal tip of the sheath melting.
The melting of the sheath tip could lead to compromised insulation, which may result in the unintentional flow of electricity to the patient. The sheath/probe is packaged separately from the outer sheath. The affected products are distributed in the Netherlands, Spain, Switzerland, Colombia, Canada, Japan, Taiwan, Puerto Rico, South Africa, and South Korea.
Healthcare providers and facilities should stop using the affected devices and contact Stryker Corporation for further instructions or replacement. The recall covers specific lot codes listed in the agency documentation.
The recalled product
- Product
- 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…
- Manufacturer
- Stryker Corporation
- Affected units
- 525
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by 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.
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