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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

1000

Past Year

899

Class I (Serious)

125

Most Recent

Jan 2026

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 681–700 of 17592 recalls

Posterior Femoral Augment (Waldemar Link) – Missing Thread Screw (2025)

The device was delivered with a preassembled Femoral Augment screw that was missing its thread.

Low

FDAApr 3, 2025Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

HistoCore PELORIS 3 (Leica Biosystems) – Tubing Leakage Issue (2025)

There is a leakage issue associated with the tubing in the manifold of the instrument.

Low

FDAApr 2, 2025AZ, CA, FL +11 more• Leica Biosystems Melbourne Pty Ltd

Italian Style Seafood Burgers (Caraluzzi's) – Undeclared Egg (2025)

Undeclared Egg

Product contains undeclared egg.

Class IHigh

1...33 343536 37...880

Page 35 of 880Next

FDA

Apr 2, 2025

• Caraluzzi's Markets

myQA iON (IBA Dosimetry) – Analysis Result Inaccuracy (2025)

Wrong analysis results can occur if the user creates two structures with the same name, except for one differing by a special character.

Moderate

FDAApr 1, 2025Nationwide• IBA Dosimetry GmbH Bahnhofstr. 5 Schwarzenbruck Germany

Triton Ultrasonic Cleaning Systems (Ultra Clean) – Sensor Degradation (2025)

During routine preventative maintenance checks, it was revealed that carbon filter sensors were breaking down due to electrochemical degradation.

Low

FDAMar 31, 2025Nationwide• Ultra Clean Systems, Inc.

enVista Monofocal IOL (Bausch & Lomb) – Toxic Segment Syndrome (2025)

In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs, and certain enVista monofocal lenses in the U.S.

High

FDAMar 27, 2025Nationwide• Bausch & Lomb Surgical, Inc.

enVista Envy IOL (Bausch & Lomb) – Toxic Segment Syndrome (2025)

High

FDAMar 27, 2025Nationwide• Bausch & Lomb Surgical, Inc.

DxI 9000 Access Immunoassay Analyzer (Beckman Coulter) – Host System Connectivity (2025)

When DxI 9000 Access Immunoassay Analyzer is connected to a host system (laboratory information system (LIS) or middleware) and has accumulated canceled QC test results that were not sent by LIS, the analyzer may lose communication with the host system. The lost connection interrupts sample processing, which delays reporting patient test results and may subsequently delay patient treatment.

Moderate

FDAMar 27, 2025Nationwide• Beckman Coulter, Inc.

Oatmeal Raisin Cookie Dough (Craftmark Bakery) – Plastic Contamination (2025)

Potential contamination with foreign material (plastic)

Class IIModerate

FDAMar 27, 2025CA, IL, MD• Craftmark Bakery, LLC

Cromer Chicken Salad (Cromer Food Services) – Undeclared Milk (2025)

Undeclared Milk

Undeclared Milk - During an FDA inspection the firm was notified that milk was not declared on the label.

Class IHigh

FDAMar 27, 2025GA, SC• Cromer Food Services, Inc

CraftMark Oatmeal Cranberry Raisin Cookie Dough (Craftmark Bakery) – Plastic Contamination (2025)

Potential contamination with foreign material (plastic)

Class IIModerate

FDAMar 27, 2025CA, IL, MD• Craftmark Bakery, LLC

Premium Monster Cookie (Craftmark Bakery) – Plastic Contamination (2025)

Potential contamination with foreign material (plastic)

Class IIModerate

FDAMar 27, 2025CA, IL, MD• Craftmark Bakery, LLC

Unisom SleepMinis (Chattem) – Nitrosamine Impurity (2025)

CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake Limit

Class IIModerate

FDAMar 26, 2025Nationwide• Chattem Inc

Duloxetine Capsules (Breckenridge) – Nitrosamine Impurity (2025)

CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.

Class IIModerate

FDAMar 26, 2025Nationwide• Breckenridge Pharmaceutical, Inc.

Desert Farms Jalapeno Mustard – process violation (2025)

The product is in violation for not having an approved filed process and for not having monitoring records.

Class IIModerate

FDAMar 26, 2025Nationwide• The Truck Farm, LLC

Restor3d Cordera Hip System (Conformis) – Incorrect Liner Labeling (2025)

The hip cup liner that was packaged with the incorrect labeling. HDL-060-C22S-000101 from Lot 1788258 contained a hooded liner, but it was labeled to have a standard liner.

Low

FDAMar 25, 2025Nationwide• Conformis Inc.

Intera 1.5T (Philips) – Coil Seal Adhesive Failure (2025)

Laceration Risk

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.

High

FDAMar 24, 2025Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

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

Recall Summary

Posterior Femoral Augment (Waldemar Link) – Missing Thread Screw (2025)

HistoCore PELORIS 3 (Leica Biosystems) – Tubing Leakage Issue (2025)

Italian Style Seafood Burgers (Caraluzzi's) – Undeclared Egg (2025)

myQA iON (IBA Dosimetry) – Analysis Result Inaccuracy (2025)

Triton Ultrasonic Cleaning Systems (Ultra Clean) – Sensor Degradation (2025)

enVista Monofocal IOL (Bausch & Lomb) – Toxic Segment Syndrome (2025)

enVista Envy IOL (Bausch & Lomb) – Toxic Segment Syndrome (2025)

DxI 9000 Access Immunoassay Analyzer (Beckman Coulter) – Host System Connectivity (2025)

Oatmeal Raisin Cookie Dough (Craftmark Bakery) – Plastic Contamination (2025)

Cromer Chicken Salad (Cromer Food Services) – Undeclared Milk (2025)

CraftMark Oatmeal Cranberry Raisin Cookie Dough (Craftmark Bakery) – Plastic Contamination (2025)

Premium Monster Cookie (Craftmark Bakery) – Plastic Contamination (2025)

Unisom SleepMinis (Chattem) – Nitrosamine Impurity (2025)

Duloxetine Capsules (Breckenridge) – Nitrosamine Impurity (2025)

Desert Farms Jalapeno Mustard – process violation (2025)

Restor3d Cordera Hip System (Conformis) – Incorrect Liner Labeling (2025)

Intera 1.5T (Philips) – Coil Seal Adhesive Failure (2025)

Intera 1.5T Omni/Stellar (Philips) – Coil Seal Adhesive Failure (2025)

Intera 3.0T Quasar Dual (Philips) – Coil Seal Adhesive Failure (2025)

SmartPath to dStream (Philips) – Coil Seal Adhesive Failure (2025)