Agency classClass IIOur severity:High FDA (Devices)·Z-1509-2020·Announced 2020-03-25

Stryker Strykeprobe Outer Sheath Replacement Recalled for Insulation Risk

Stryker is recalling Strykeprobe Outer Sheath Replacements because a length mismatch could cause the probe to melt, compromising insulation and allowing electricity to flow to the patient.

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 electrical injury to patients due to compromised insulation, which is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Stryker Corporation is recalling Strykeprobe Outer Sheath Replacements (REF: 0250070450) due to a potential difference in length between the sheath tube and the sheath/probe. This discrepancy could prevent the base of the probe from being fully seated in the sheath tube, potentially causing the distal tip of the sheath to melt.

The melting of the sheath tip could lead to compromised insulation, resulting in the unintentional flow of electricity to the patient. The affected sheath/probe is packaged separately from the replacement sheath. The recall includes specific lot numbers: 010818-02, 010818-05, 010818-06, 010818-07, 010818-08, 010818-09, 040816-01, and 040816-02.

The product was distributed in the Netherlands, Spain, Switzerland, Colombia, Canada, Japan, Taiwan, Puerto Rico, South Africa, and South Korea. Healthcare providers and patients should stop using the affected devices and contact Stryker Corporation for further instructions.

The recalled product

Product: Stryker, REF: 0250070450, 5.0 mm x 45 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Sterile, CE, UDI: (01) 07613327051926 This products was distributed with the following sheath/probe: 0250070451-PKG, 5MM X 45CM StrykeProbe Electrosurgical Probe, Spatula-Tip…
Manufacturer: Stryker Corporation
Category: Medical Device — Electrosurgical Instrument
Hazard: electrical-shock
insulation-failure

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 (8)

Lot Numbers: 010818-02
010818-05
010818-06
010818-07
010818-08
010818-09
040816-01
040816-02

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.

See all 2 products in this recall →

Same manufacturer · Stryker Corporation

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Same hazard · electrical shock