Recall Atlas
Drugs & medicalClass II

Stryker Leibinger GmbH & Co. KG recalls Precision Pointer Electromagnetic (8000-050-001)

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.

Read the official notice →
Date
2026-11-04
Country
United States
Brand
Stryker Leibinger GmbH & Co. KG
Product
Precision Pointer Electromagnetic (8000-050-001)
Classification
Class II
Units
Worldwide - US Nationwide distribution in the states of Alabama, Arizona,…
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Stryker Leibinger GmbH & Co. KG recalls

  1. 2024-05-29
  2. Drugs & medicalClass II

    Stryker Leibinger GmbH & Co. KG recalls 8000-021-002, Scopis¿ ENT Software with TGS¿ with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generation solution for…

    Unreleased software was installed on customer systems resulting in the visual feedback on the screen to show the points to be off from the physical reference point of the pointer or suction.

    FDA · DeviceStryker Leibinger GmbH & Co. KGUS Nationwide distribution.Official notice →
  3. 2024-05-15
  4. Drugs & medicalClass II

    Stryker Leibinger GmbH & Co. KG recalls Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, stabilization and rigid fixation of the bony areas…

    Mislabeled: Product labeled 56-90614 (90x90 Gold Mesh), was actually 56-90314 (90x90 Blue Mesh), may cause a delay in procedure

    FDA · DeviceStryker Leibinger GmbH & Co. KGNationwideOfficial notice →
  5. 2023-03-15
  6. Drugs & medicalClass II

    Stryker Leibinger GmbH & Co. KG recalls Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis

    Device was shipped without having regulatory approval.

    FDA · DeviceStryker Leibinger GmbH & Co. KGDistribution of one unit only to a single customer in MA (USA)Official notice →
  7. 2022-03-09
  8. Drugs & medicalClass II

    Stryker Leibinger GmbH & Co. KG recalls MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032

    Inside the packaging of one reported item a non-conforming product was found. Contrary to the design, the barrier layer was manufactured on the inferior side of the implant versus the superior side.

    FDA · DeviceStryker Leibinger GmbH & Co. KGWorldwide distribution - US Nationwide.Official notice →
All 5 Stryker Leibinger GmbH & Co. KG recalls →

Other drugs & medical recalls in the United States

  1. 2026-11-04
  2. Drugs & medicalClass II

    ARJOHUNTLEIGH POLSKA Sp. z.o.o. recalls Carevo, Height-adjustable shower trolley, Model Number BAC1111-01

    The side support of the shower trolley may open unintentionally when the handles are not fully locked and additional force is applied during patient handling. If the side support is not fully locked and an additional…

    FDA · DeviceARJOHUNTLEIGH POLSKA Sp. z.o.o.US Nationwide distribution.Official notice →
  3. Drugs & medicalClass II

    Boston Scientific Neuromodulation Corporation recalls Nalu TD2 Therapy Disc with firmware, REF: 34014-001, and TD2 Patient Kit, REF: 74011, part of the Nalu…

    Therapy Disc (TD) that powers and sends stimulation signals to an Implantable Pulse Generator (IPG), part of a neurostimulation system, has a firmware issue that causes the TD to attempt to restart, then fail, leading…

    FDA · DeviceBoston Scientific Neuromodulation CorporationUS Nationwide distribution in the states of PA, FL, OR, AZ, OH, SC, TX, OR,…Official notice →
  4. Drugs & medicalClass II

    Pentax of America Inc recalls PENTAX Medical Ultrasound Endoscope. Model Numbers. EG-3870UTK, EG-3670URK.

    Warnings added to the IFU for ultrasound endoscopes and water bottle assembly to ensure there is deaerated sterile water in the assembly prior to and during the procedure.

    FDA · DevicePentax of America IncWorldwide - US Nationwide and International distribution - Pending.Official notice →
  5. Drugs & medicalClass II

    Medtronic, Inc. recalls CareLink SmartSync Programmer, Model 24970A, Pulse generator, permanent, implantable

    Software problem has the potential for an inaccurate displayed longevity estimate.

    FDA · DeviceMedtronic, Inc.Worldwide distribution.Official notice →
  6. Drugs & medicalClass II

    BioMerieux SA recalls EMAG system Model/Catalog Number: 418591/418591U Product Description: Nucleic acid sample preparation instrument IVD, automated

    Delayed or no result when analyzing clinical samples with EMAG system (ref: 418591/418591U) due to a randomly occurring software error, Error 10003 Heater timeout after updating to recent firmware SP4 Patch 2

    FDA · DeviceBioMerieux SAWorldwide - US Nationwide distribution in the states of CA, IN, KS, LA, MN,…Official notice →
  7. Drugs & medicalClass II

    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion 5 M12. Model Number: 722227.

    Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced reliability over…

    FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Afghanistan,…Official notice →
See all drugs & medical recalls →