Precision Pointer Electromagnetic recall (Stryker Leibinger GmbH & Co. KG)
Medical deviceClass IIOngoing
Summary: Stryker Leibinger GmbH & Co. KG is recalling Precision Pointer Electromagnetic (8000-050-001). Reason: 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 is being recalled
Precision Pointer Electromagnetic (8000-050-001)
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
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 named: 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)
How to tell if yours is affected
Lot 7000413361 UDI-DI 07613327413205
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-0314-2027 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | September 24, 2026 |
| Reported | November 4, 2026 |
| Company | Stryker Leibinger GmbH & Co. KG |
| Company location | Freiburg Im Breisgau, Germany |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 513 |
More recalls from Stryker Leibinger GmbH & Co. KG · all medical device recalls · recalls from September 2026