FDA Medical devices recall ·
Precision Pointer Electromagnetic (8000-050-001) recall
- Recall number
- Z-0314-2027
- Date
- (initiated September 24, 2026)
- Company / brand
- Stryker Leibinger GmbH & Co. KG
Botzinger Str. 39-41, Freiburg Im Breisgau, Germany - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 513
- Hazard tags
- Fall
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Precision Pointer Electromagnetic (8000-050-001)
Why was it recalled?
Device may fracture during use at the laser welded joint on the pointer tube. If this happens, loose parts may fall out of the product while the device is inside the patient.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot 7000413361 UDI-DI 07613327413205
Distribution
Worldwide - US Nationwide distribution in the states of Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Hawaii, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, Montana, New Hampshire, New York, Ohio, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Washington and the countries of Austria, Canada, Denmark, Finland, France, Germany, Ireland, Italy, Japan, Norway, Portugal, South Korea, Spain, Switzerland, UK.
States: Alabama Arizona California Colorado Connecticut Delaware Florida Hawaii Illinois Indiana Kentucky Louisiana Massachusetts Michigan Missouri Montana New Hampshire New York Ohio Pennsylvania South Carolina South Dakota Tennessee Texas Utah Washington
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0314-2027. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.