Stryker Corporation: 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.

Agency Publication Date: March 17, 2020

Affected Products

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 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 Pr

Lot codes: 010318 02 010318 03 010318 04 010318 05 010318 06 010318 07 010318 08 010318 10 010518 01 010518 02 010518 03 010518 04 010518 05 010518 06 010518 07 010518 08 010518 09 010518 10 011819 01 011819 04 011819 06 011819 07 011819 08 011819 09 011819 10 012219 01 012219 02 012219 03 012219 04 012219 05 012219 06 012219 07 012219 08 012219 09 012219 10 012219 12 021018 01 021018 02 021018 03 021018 04 021018 05 021018 07 021018 08 021018 09 021018 10 021018 11 021018 12 021018 13 021018 14 021018 15 021018 16 021018 17 021018 18 021018 19 022718 01 022718 02 022718 03 022718 04 022718 05 022718 06 022718 07 022718 08 022718 09 022718 10 022718 11 022718 12 022718 13 022718 14 022718 15 022718 18 022718 19 022718 20 070618 01 070618 02 070618 03 070618 04 070618 05 070618 06 070618 07 080416 02 080818 09 080818 10 081518 01 081518 02 081518 03 081518 04 081518 06 081518 07 083018 01 083018 02 083018 03 083018 04 083118 02 083118 04 083118 05 083118 07 083118 08 083118 09 083118 10 091318 01 091318 02 091318 03 091318 05 091318 06 091318 07 091318 08 091318 09 101018 01 101018 02 101018 03 101018 04 101018 05 101018 06 101018 07 101018 09 101018 10 110218 01 110218 02 110218 03 110218 04 110218 05 110218 06 110218 08 110218 09 110218 10 110507 02

Lot Numbers:

codes

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, 0250070452-PKG, 5MM X 45CM StrykeProbe Electrosurgical Probe, J-TIP, 0250070453-PKG, 5MM X 45CM StrykeProbe Electrosurgical Probe, L-TIP, 0250070455-PKG, 5MM X 45CM StrykeProbe Electrosurgical Probe, Needle Tip

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

Lot Numbers:

Numbers

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85100

Status: Resolved

Manufacturer: Stryker Corporation

Manufactured In: United States

Units Affected: 525 devices

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Lot Numbers:

codes

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

Lot Numbers:

Numbers