FDA recall, , Moderate risk
Stryker Leibinger Precision Pointer Electromagnetic
The Precision Pointer Electromagnetic may fracture during use, and loose parts may fall out while inside the patient.
Summary by Recall Canary from the FDA notice
What happened
Stryker Leibinger GmbH & Co. KG, based in Freiburg Im Breisgau, Germany, voluntarily initiated a recall of the Precision Pointer Electromagnetic (8000-050-001) on September 24, 2026. The device may fracture during use at the laser welded joint on the pointer tube, and if this happens, loose parts may fall out of the product while the device is inside the patient.
The recall was added to the FDA's Enforcement Report on October 29, 2026, and classified by the FDA on the same date.
Distribution included US nationwide states such as 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, and Washington, as well as countries including Austria, Canada, Denmark, Finland, France, Germany, Ireland, Italy, Japan, Norway, Portugal, South Korea, Spain, Switzerland, and the UK.
Customers were notified by letter.
What to do
The FDA notice gives no instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Precision Pointer Electromagnetic (8000-050-001)
- UDI-DI
- 07613327413205
- Lot code
- 7000413361
Recall details
- Posted by FDA
- Recall began
- Status
- Open
- Weekly archive
- Listed the week of Oct 26, 2026
- Sold in
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.
- Recalled by
- Stryker Leibinger GmbH & Co. KGFreiburg Im Breisgau, Germany
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- FDA event number
- 99855
- Recall number
- Z-0314-2027
- Recall type
- Voluntary: Firm initiated
- How the company first told customers
- Letter
All recalls from Stryker Leibinger GmbH & Co. KG
Timeline
FDA's Enforcement Report is its public list of recalls; FDA posts a recall by adding it there.
Stryker Leibinger GmbH & Co. KG began the recall
FDA posted the recall to its Enforcement Report and rated it Class II (moderate risk)
Added to Recall Canary
Summary updated
