Z-1509-2020Class II

Stryker, REF: 0250070450, 5.0 mm x 45 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Sterile, CE...

Name: Z-1509-2020 Stryker, REF: 0250070450, 5.0 mm x 45 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Sterile, CE...
Creator: Stryker Corporation
Published: 2019-09-12
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2019-09-12 / Terminated / root cause: packaging

FDA source

Stryker Corporation began a recall of Stryker, REF: 0250070450, 5.0 mm x 45 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Sterile, CE, UDI: (01) 07613327051926 This products was... on 2019-09-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1509-2020
Classification: Class II
Status: Terminated
Initiated: 2019-09-12
Posted: 2020-03-17
Terminated: 2022-10-31
Recalling firm: Stryker Corp.
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
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
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.
Root cause tag: packaging
FDA root cause: Other
Action: On September 25, 2019 and November 26, 2019, the firm sent an "Urgent Medical Device Recall Notification" letter to all consignees via USPS mail. In addition, to informing consignees about the recall, they recall letter asked consignees to take the following actions: Actions to be taken by the Customer/User: 1. Inform individuals within your organization who need to be aware of this device removal. 2. Check all stock areas and/or operating room storage to determine if any devices with the affected Strykeprobe Sheath lot numbers from Attachment A are at your facility. - a. If you would like a list of all affected probe lot numbers, please email [email protected] 3. If affected product is found, segregate the product and call Stryker customer service at 1-800-624-4422 (Option 3) or email [email protected] to arrange for product return and issuance of credit or replacement (upon availability). - a. Remove the affected sheath, quarantine, and discontinue use of the identified non-conforming recalled sheath(s). - b. When returning units, please enclose Business Reply Form on Attachment B. 4. If affected product is NOT found: - a. Please complete Business Reply Form on Attachment B and return to [email protected] 5. Please forward a copy of this letter to any other personnel within your facility you deem appropriate. 6. Please send any questions to [email protected].
Distribution: OUS: Netherlands, Spain, Switzerland, Colombia, Canada, Japan, Taiwan,, Puerto Rico, South Africa, and South Korea
Product codes and lots: Lot Numbers: 010818-02, 010818-05, 010818-06, 010818-07, 010818-08, 010818-09, 040816-01, 040816-02

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1509-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1508-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-25	2020-03-17
Z-1509-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-25	2020-03-17

Product code GEI

K934094Class IIStryker Laparoscopic Suction IrrigatorStryker Corp. / cleared 1994-02-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)