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Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany Recalls

All product recalls associated with Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt 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 61–80 of 624 recalls

LINK MP Reconstruction System (Waldemar Link) – Incorrect Label Size (2024)

Error on the main label and the patient label. The labels indicate a size XXL, this is a standard-size neck segment.. All further information on the labels is correct (Length, CCD and Offset).

Low

FDADec 5, 2024Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

Surgical Sheath 20 Fr (Trokamed) – Inflow Speed Risk (2024)

If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly build up of intrarenal pressure.

High

FDANov 27, 2024IN, PA• Trokamed GmbH Kleine Breite 17 Geisingen Germany

Surgical Sheath 20 Fr (Trokamed) – Inflow Speed Risk (2024)

If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly build up of intrarenal pressure.

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High

FDANov 27, 2024IN, PA• Trokamed GmbH Kleine Breite 17 Geisingen Germany

Surgical Sheath 18 Fr (Trokamed) – Inflow Speed Risk (2024)

If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly build up of intrarenal pressure.

High

FDANov 27, 2024IN, PA• Trokamed GmbH Kleine Breite 17 Geisingen Germany

Surgical Sheath 18 Fr (Trokamed) – Inflow Speed Risk (2024)

If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly build up of intrarenal pressure.

High

FDANov 27, 2024IN, PA• Trokamed GmbH Kleine Breite 17 Geisingen Germany

VACUETTE SAFELINK (Greiner Bio-One) – Blood Leakage Risk (2024)

The VACUETTE SAFELINK Holder with male luer lock may leak blood due to the protective rubber sleeve bunching up and not retracting when using the device.

Moderate

FDANov 19, 2024Nationwide• Greiner Bio-One GmbH Bad Haller Strase

mint Lesion Software 3.9.0 (Mint Medical) – Orientation Label Error (2024)

Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images.

Moderate

FDANov 15, 2024Nationwide• Mint Medical GmbH Friedrich-Ebert-Str. 2 Dossenheim Germany

Wegmans Asian Sesame Salad – Undeclared Egg (2024)

Undeclared Egg

Contains undeclared egg

Class IHigh

FDANov 8, 2024DE, MD, MA +6 more• Wegmans Food Markets, Inc.

2022 GMC Savana (GMC) – Transmission Software Problem (2024)

General Motors, LLC (GM) is recalling certain 2022-2023 Chevrolet Express and GMC Savana vehicles. Incorrect software in the transmission control module (TCM) may result in harsh shifting, reduced power, unintended deceleration, rear wheel lockup, or cause the vehicle to move in an unintended direction.

High

NHTSANov 7, 2024Nationwide• GMC

Essenz HLM (LivaNova) – Touchscreen Interruption (2024)

Heart-Lung Machine GUI touchscreen may go dark for 10-15 seconds, safety/performance functions remain operational before reset, control maintained through backup control panel, but second reset may occur, may lead to gas blender standby, then gas blender must be reactivated using user interface on blender, sensors deactivated until new case started; GUI reset can lead to Hypoxia and Hypoperfusion.

High

FDAOct 18, 2024Nationwide• LivaNova Deutschland GmbH Lindberghstr. 25 Munich Germany

GMC Sierra EV (GMC) – Turn Signal Brightness Issue (2024)

General Motors, LLC (GM) is recalling certain 2024 GMC Sierra EV vehicles. The front turn signal lights and parking lights may be too similar in brightness, making it difficult to see the front turn signals when they are activated. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 108, "Lamps, Reflective Devices, and Associated Equipment."

High

NHTSAOct 10, 2024Nationwide• GMC

GMC Sierra 3500 (GMC) – Airbag Curtain Inflator Issue (2024)

General Motors, LLC (GM) is recalling certain 2018 Chevrolet Silverado 1500, GMC Sierra 1500, 2018-2019 Chevrolet Silverado 2500, 3500, and GMC Sierra 2500, 3500 Crew Cab trucks. The left or right-side roof-rail air bag (RRAB) inflator end cap may detach from the inflator or the inflator sidewall may rupture.

High

NHTSAOct 10, 2024Nationwide• GMC

GMC Canyon (GMC) – Seat Fastener Problem (2024)

General Motors, LLC (GM) is recalling certain 2023-2024 Chevrolet Colorado and 2023 GMC Canyon vehicles. The left or right front seat may have a seat belt buckle attachment bolt that was not tightened properly.

Moderate

NHTSASep 19, 2024Nationwide• GMC

GMC Canyon (GMC) – Headlight Flickering (2024)

General Motors, LLC (GM) is recalling certain 2024 GMC Canyon vehicles. The headlights may flicker while driving and while the vehicle is in park. As such, these vehicles fail to comply with the requirements of Federal Motor Safety Standard number 108, "Lamps, Reflective Devices, and Associated Equipment."

Moderate

NHTSASep 12, 2024Nationwide• GMC

GMC Yukon XL (GMC) – Brake Fluid Warning (2024)

General Motors, LLC (GM) is recalling certain 2023 Chevrolet Silverado 1500, GMC Sierra 1500, 2023-2024 Chevrolet Tahoe, Suburban, GMC Yukon, Yukon XL, Cadillac Escalade, and Escalade ESV vehicles. The electronic brake control module software may fail to display a warning light when a loss of brake fluid occurs. As such, these vehicles fail to comply with the requirements of Federal Vehicle Safety Standard number 135, "Light Vehicle Brake Systems."

Moderate

NHTSASep 12, 2024Nationwide• GMC

LINK Universal Handle (Waldemar Link) – Material Failure Risk (2024)

Some lots of the LINK Universal Handle, with quick coupling, Stainless Steel, straight may suffer an immediate material failure intraoperatively when the instrument is used for the first time. The instrument can break in the middle.

High

FDASep 11, 2024Nationwide• Waldemar Link GmbH & Co. KG (Corp. Hq.) Barkhausenweg 10 Hamburg Germany

Leica Biosystems Cryostat (Leica) – Flammable Spray Risk (2024)

As part of our post market surveillance, we recognized that some customers are using flammable freezing sprays within the cryostat chamber. All flammable freezing sprays can potentially ignite and therefore can cause serious injuries. The flammability is indicated on the labelling of these sprays. The cryostat labelling, however, did not include any specific warning about usage of flammable freezing sprays prior to 2019.

High

FDASep 4, 2024Nationwide• LEICA BIOSYSTEMS NUSSLOCH GMBH Heidelberger Str. 17-19 Nussloch Germany

ViewPoint Imaging System (GE Healthcare) - Cybersecurity Vulnerability (2024)

The National Institute of Standards and Technology (NIST) has identified in the National Vulnerability Database (NVD) that NexGen Healthcare Mirth Connect, prior to version 4.4.1, has a potential vulnerability allowing the deserialization of untrusted data (CVE-2023-43208). Mirth products may have been installed and configured with your ViewPoint / ViewPoint 6 system by GE HealthCare. This vulnerability could allow a malicious actor to access the system and potentially manipulate patient data.

FDAAug 8, 2024Nationwide• GE Healthcare GmbH Oskar-Schlemmer-Str. 11 Munich Germany

Biolox Option Taper Sleeve (Zimmer) - Mislabeling Concern (2024)

Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck sleeve, however, the product within the box is a -6mm neck sleeve, and vice versa. The neck of the sleeve can be identified by the device etching as either STD or -6

FDAAug 8, 2024Nationwide• Zimmer GmbH Sulzerallee 8 Winterthur Switzerland

ViewPoint 6 System (GE Healthcare) - Cybersecurity Vulnerability (2024)

FDAAug 8, 2024Nationwide• GE Healthcare GmbH Oskar-Schlemmer-Str. 11 Munich Germany