CLASS II Device recall · Reported 25 Mar 2020 · FDA Enforcement Report
Stryker, REF: 0250070450, 5.0 mm x 45 cm, Strykeprobe, Outer Sheath recalled
Stryker is recalling Stryker, REF: 0250070450, 5.0 mm x 45 cm, Strykeprobe, Outer Sheath, distributed in Puerto Rico. The recall was initiated on 12 Sep 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1509-2020
- FDA event ID
- 85100
- Recalling firm
- Stryker, San Jose, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Sep 2019
- FDA classified
- 17 Mar 2020
- Reported
- 25 Mar 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Surgical Instruments
Timeline
| 12 Sep 2019 | Recall initiated by company | |
| 17 Mar 2020 | Classified by FDA | +187 days |
| 25 Mar 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
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
Where it was distributed
OUS: Netherlands, Spain, Switzerland, Colombia, Canada, Japan, Taiwan,, Puerto Rico, South Africa, and South Korea
Questions about this recall
Is Stryker, REF: 0250070450, 5.0 mm x 45 cm, Strykeprobe, Outer Sheath recalled?
Yes. Stryker recalled Stryker, REF: 0250070450, 5.0 mm x 45 cm, Strykeprobe, Outer Sheath on 12 Sep 2019. The recall is Class II and its status is Terminated. Recall number Z-1509-2020.
Why was it 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.
Which lots are affected?
Lot Numbers: 010818-02, 010818-05, 010818-06, 010818-07, 010818-08, 010818-09, 040816-01, 040816-02
Where was it sold?
OUS: Netherlands, Spain, Switzerland, Colombia, Canada, Japan, Taiwan,, Puerto Rico, South Africa, and South Korea
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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