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Roche Diagnostics Operations, Inc.

Roche Diagnostics Operations, Inc. Recalls

All product recalls associated with Roche Diagnostics Operations, Inc..

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Recall Summary

Total Recalls

1000

Past Year

88

Class I (Serious)

98

Most Recent

Nov 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 1–20 of 2399 recalls

The Elecsys Anti-TSHR immunoassay is a three-step competi... (Roche Diagnostics Operations, Inc.) – issues identified: 1) results vary by... (2025)

Issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. Issues may lead to delayed or incorrect diagnosis, as well as delay of treatment or incorrect treatment.

FDANov 21, 2025Nationwide• Roche Diagnostics Operations, Inc.

Sheathes3D Seamless Viral Barrier, Latex-Free, 7/8"D Tape... (Sheathing Technologies Inc) – vaginal/rectal ultrasound probe cover... (2025)

Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk.

FDANov 17, 2025Nationwide• Sheathing Technologies Inc

Oven Dried Fish (African Food on Wheels) – Botulinum Risk (2025)

Clostridium botulinum (uneviscerated fish)

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Class I

High

FDANov 5, 2025IN, NY• African Food on Wheels Inc.

Peach Salsa (JFE Franchising) – Listeria Risk (2025)

Peaches provided by Moonlight Peaches potentially contaminated with Listeria.

FDAOct 29, 2025AL, AZ, CO +15 more• JFE FRANCHISING INC

5008X CAREsystem (Fresenius) – Software Anomaly Risk (2025)

Several software anomalies with the potential to impact patient treatment, of which one includes the possibility to result in treatment stop if certain conditions are fulfilled.

FDAOct 25, 2025LA, MA, MN• Fresenius Medical Care Holdings, Inc.

EchoLakeFoods Precooked Eggs (Echo Lake Foods) – Listeria Contamination (2025)

Potential Listeria monocytogenes contamination.

FDAOct 23, 2025CA• Echo Lake Foods, Inc.

Mozzarella Parmesan Cheese Blend (Great Lakes) – Metal Fragments (2025)

Potential metal fragments from supplier raw material (downstream recall)

Class IIModerate

FDAOct 3, 2025AL, AZ, AR +29 more• Great Lakes Cheese Co Inc

Pizza Cheese Blend (Great Lakes) – Metal Fragments (2025)

Potential metal fragments from supplier raw material (downstream recall)

Class IIModerate

FDAOct 3, 2025AL, AZ, AR +29 more• Great Lakes Cheese Co Inc

Aldi Italian Cheese Blend (Great Lakes) – Metal Fragments (2025)

Potential metal fragments from supplier raw material (downstream recall)

Class IIModerate

FDAOct 3, 2025AL, AZ, AR +29 more• Great Lakes Cheese Co Inc

Food Club Pizza Cheese Blend (Great Lakes) – Metal Fragments (2025)

Potential metal fragments from supplier raw material (downstream recall)

Class IIModerate

FDAOct 3, 2025AL, AZ, AR +29 more• Great Lakes Cheese Co Inc

Mozzarella Shredded Cheese (Great Lakes) – Metal Fragments (2025)

Potential metal fragments from supplier raw material (downstream recall)

Class IIModerate

FDAOct 3, 2025AL, AZ, AR +29 more• Great Lakes Cheese Co Inc

Mozzarella Provolone Cheese (Great Lakes) – Metal Fragments (2025)

Potential metal fragments from supplier raw material (downstream recall)

Class IIModerate

FDAOct 3, 2025AL, AZ, AR +29 more• Great Lakes Cheese Co Inc

Italian Shredded Cheese Blend (Great Lakes) – Metal Fragments (2025)

Potential metal fragments from supplier raw material (downstream recall)

Class IIModerate

FDAOct 3, 2025AL, AZ, AR +29 more• Great Lakes Cheese Co Inc

Optiflux Dialyzer (Fresenius) – Cap Configuration (2025)

To provide further information to the user to ensure proper use of the medical device. the caps had been changed from a threaded version to a press-on version whereby the user must press the caps firmly onto the dialyzer to securely affix the cap.

FDAAug 29, 2025Nationwide• Fresenius Medical Care Holdings, Inc.

Cyclobenzaprine Tablets (Unichem) – Labeling Mix-Up (2025)

Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in color).

FDAAug 27, 2025Nationwide• Unichem Pharmaceuticals USA Inc.

Taurine Performance (PrimeNutrition) – Unapproved Claims (2025)

Unapproved Drug Claims and Misbranded.

FDAAug 6, 2025AL, AZ, AR +46 more• Hi-Tech Pharmaceuticals Inc.

Joint-RX (Hi-Tech Pharmaceuticals) – Unapproved Claims (2025)

Unapproved Drug Claims.

FDAAug 6, 2025AL, AZ, AR +46 more• Hi-Tech Pharmaceuticals Inc.

Battle Hardener Platinum (LG Sciences) – Unapproved Claims (2025)

Unapproved Drug Claims.

FDAAug 6, 2025AL, AZ, AR +46 more• Hi-Tech Pharmaceuticals Inc.

Pine Bark (Hi-Tech Pharmaceuticals) – Unapproved Claims (2025)

Unapproved Drug Claims and Misbranded.

FDAAug 6, 2025AL, AZ, AR +46 more• Hi-Tech Pharmaceuticals Inc.

L-Glutamine Powder (Hi-Tech Pharmaceuticals) – Unapproved Claims (2025)

Unapproved Drug Claims.

FDAAug 6, 2025AL, AZ, AR +46 more• Hi-Tech Pharmaceuticals Inc.