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LEICA BIOSYSTEMS NUSSLOCH GMBH Heidelberger Str. 17-19 Nussloch Germany

LEICA BIOSYSTEMS NUSSLOCH GMBH Heidelberger Str. 17-19 Nussloch Germany Recalls

All product recalls associated with LEICA BIOSYSTEMS NUSSLOCH GMBH Heidelberger Str. 17-19 Nussloch Germany.

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Recall Summary

Total Recalls

624

Past Year

Class I (Serious)

Most Recent

Dec 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 121–140 of 624 recalls

Leica HistoCore PEGASUS (Leica) – Tissue Processing Issue (2023)

There is an issue regarding poorly processed and/or damaged biopsy tissue specimens on the HistoCore PEGASUS / HistoCore PEGASUS Plus resulting from an incorrect assignment of the carryover value set for created or edited protocols.

FDANov 20, 2023Nationwide• LEICA BIOSYSTEMS NUSSLOCH GMBH Heidelberger Str. 17-19 Nussloch Germany

SagiPlan 2.2 (Bebig) – measurement accuracy issue (2023)

Due to software malfunction, numerical values may be rounded resulting in inaccurate measurements.

FDAOct 17, 2023MD• Bebig Isotopentechnik Gmbh Robert-Rossle-Str. 10 Berlin Germany

GMC Acadia (GMC) – windshield assembly risk (2023)

General Motors, LLC (GM) is recalling certain 2023 GMC Acadia and 2024 Cadilac XT5 and XT6 vehicles. The windshield may have been assembled without the proper urethane sealant required to bond the windshield to the vehicle body.

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NHTSA

Oct 12, 2023

Nationwide

• GMC

D-Clip Applier (Peter Lazic) – Surgery Failure Risk (2023)

Customer complaint received that reported the applier failed during surgery. The applier did not release the clip. The applier remained attached to the clip.

FDAOct 6, 2023Nationwide• Peter Lazic Gmbh Immelmannweg 2 Tuttlingen Germany

D-Clip Applier (Peter Lazic) – Surgery Failure Risk (2023)

Customer complaint received that reported the applier failed during surgery. The applier did not release the clip. The applier remained attached to the clip.

FDAOct 6, 2023Nationwide• Peter Lazic Gmbh Immelmannweg 2 Tuttlingen Germany

Therascreen KRAS RGQ PCR Kit (Qiagen) – Handbook Revision Issue (2023)

Handbook Revision (Rev13) a dilution step is indicated as an Action when having the Flag SAMPLE_INT_CTRL_FAIL. A dilution of CRC tissue could lead to a false negative result. To remove ambiguity, an alteration must be made to the S the sample result with this flag should be interpreted as invalid

FDAAug 22, 2023Nationwide• Qiagen GmbH Qiagen Str. 1 Hilden Germany

Exoplan Software (Exocad) – Export Filtering Error (2023)

A software library filtering error has been discovered which occurs when users are using the Step-by-Step Full Drill Protocol export functionality of exoplan 3.1 Rijeka. When a guided surgery treatment approach is selected, along with a Step-by-Step Full Drill Protocol export implant library, exoplan software does not filter out unsupported sleeve height positions for a particular sub-full drill protocol and instead shows ALL possible sleeve height positions for all sub-full drill protocols. The use of an improper sleeve height position in a surgical guide could result in patient injury

FDAAug 17, 2023Nationwide• Exocad GmbH Julius-Reiber-Str. 37 Darmstadt Germany

Oculus Myopia Master (Oculus) – Coating Measurement Risk (2023)

Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.

FDAAug 8, 2023Nationwide• Oculus Optikgeraete GMBH Munchholzhauser Str. 29 Wetzlar Germany

Oculus Pentacam AXL Wave (Oculus) – Coating Measurement Risk (2023)

Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.

FDAAug 8, 2023Nationwide• Oculus Optikgeraete GMBH Munchholzhauser Str. 29 Wetzlar Germany

Oculus Pentacam AXL (Oculus) – Coating Measurement Risk (2023)

Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.

FDAAug 8, 2023Nationwide• Oculus Optikgeraete GMBH Munchholzhauser Str. 29 Wetzlar Germany

3T Heater Cooler System (LivaNova) – maintenance schedule error (2023)

The firm's labeling (Quick Reference Guide) contains incorrect information in the maintenance schedule for the Heater-Cooler device.

FDAAug 3, 2023Nationwide• LivaNova Deutschland GmbH Lindberghstr. 25 Munich Germany

Henke-Ject-2 Syringes (Wolf) – sterile barrier damage (2023)

Sterile barrier might be damaged compromising the sterility of the device.

FDAJul 27, 2023Nationwide• Wolf, Henke Sass, Gmbh Kronenstrasse 16 Tuttlingen Germany

OptiStem Rasp Handle (Waldemar Link) – weld crack risk (2023)

A crack in the weld of the rasp handle may lead to a fracture of the frontal sleeve when the rasp is further impacted or extracted. The rasp remains intact. The rasp would need to be pulled out by a clamp leading to a prolongation of surgery or modified surgery

FDAJul 26, 2023GA, IN, TX• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

L-Aneurysm Clip (Peter Lazic) – Incorrect Color (2023)

Wrong product coloring. The paddle clips should be blank, but they are colored blue.

FDAJul 14, 2023Nationwide• Peter Lazic Gmbh Immelmannweg 2 Tuttlingen Germany

MobileLink Acetabular Cup (Waldemar Link) – Incorrect Offset (2023)

Product is labeled with incorrect offset.

FDAJul 14, 2023AL, NV, NJ• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size ... (Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany) – increased force may be required to re... (2023)

Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue

FDAJul 3, 2023Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

UroLift Visual Obturator (Scholly Fiberoptic) – Weld Defect (2023)

There is an improperly performed weld between the cone of the sheath lock and tube of the obturator; mechanical load capacity is impaired, and fracture of the welded joint may occur. Contamination can occur in this capillary gap, which is not covered by the reprocessing validations performed.

FDAJun 23, 2023Nationwide• Scholly Fiberoptic Gmbh Robert-Bosch-Str. 1-3 Denzlingen Germany

DxA Automation System (Beckman Coulter) – Test Sample Compatibility (2023)

A software defect in the DxA Automation System may cause tests to be run on patient samples in tube types not compatible with the requested test, leading to erroneous patient results

FDAJun 2, 2023AL, CA, FL +16 more• Beckman Coulter Biomedical GmbH Sauerbruchstr. 50 Munchen Germany

UFSK Treatment Chair 500 XLE (UFSK) – Drive Mechanism Wear (2023)

Service life of the electrical seat part drive of the treatment chair may be shortened unexpectedly after several years of use due to a potential wear-related reduction in the self-locking of the drive and may remain undetected. A worsened self-locking of the seat drive can lead to overriding the drive s end position when positioning the patient with the seat part in an inclined position

FDAMay 31, 2023Nationwide• UFSK International OSYS Gmbh Kirchhoffstr. 1 Ratisbon Germany

GE Vivid S60N Ultrasound (GE Vingmed) – System Boot Delay (2023)

GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely fashion. If this occurs, it can delay availability of the device in time-critical emergency situations.

FDAMay 30, 2023Nationwide• GE Vingmed Ultrasound As Strandpromenaden 45 Horten Norway