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Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc. Recalls

All product recalls associated with Siemens Healthcare Diagnostics, Inc..

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Recall Summary

Total Recalls

1000

Past Year

1000

Class I (Serious)

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 3841–3860 of 21320 recalls

Atellica CH HDL Cholesterol- In vitro diagnostic use in ... (Siemens Healthcare Diagnostics, Inc.) – potential for reagent carryover on th... (2023)

Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atellica CH Total Bilirubin_2 (TBil_2), Atellica CH LDL Cholesterol (LDLC), Atellica CH Gamma-Glutamyl Transferase (GGT) and Atellica CH HDL Cholesterol (HDLC)

Moderate

FDAJul 10, 2023Nationwide• Siemens Healthcare Diagnostics, Inc.

Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnost... (Siemens Healthcare Diagnostics, Inc.) – potential for reagent carryover on th... (2023)

Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from AtellicaCH Total Bilirubin_2 (TBil_2), Atellica CH LDL Cholesterol (LDLC), Atellica CH Gamma-Glutamyl Transferase (GGT) and Atellica CH HDL Cholesterol (HDLC)

Moderate

FDAJul 10, 2023Nationwide• Siemens Healthcare Diagnostics, Inc.

1...191 192193194 195...1066

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Atellica CH LDL Cholesterol- In vitro diagnostic use in t... (Siemens Healthcare Diagnostics, Inc.) – potential for reagent carryover on th... (2023)

Moderate

FDAJul 10, 2023Nationwide• Siemens Healthcare Diagnostics, Inc.

SPICER DRIVESHAFT – dana incorporated (dana) is recalling... (2023)

Dana Incorporated (Dana) is recalling certain Dana-Spicer Driveshafts, model number SPL100 DS/CS. The driveshafts can break under certain loading conditions.

High

NHTSAJul 10, 2023Nationwide• SPICER

Tiagabine Hydrochloride Tablets (Sun Pharma) – Impurity Failure (2023)

Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing

Class IIModerate

FDAJul 10, 2023Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Atellica CH Total Bilirubin_2 -In vitro diagnostic use in... (Siemens Healthcare Diagnostics, Inc.) – potential for reagent carryover on th... (2023)

Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atellica CH Total Bilirubin_2 (TBil_2), AtellicaCH LDL Cholesterol (LDLC), Atellica CH Gamma-Glutamyl Transferase (GGT) and AtellicaCH HDL Cholesterol (HDLC)

Low

FDAJul 10, 2023Nationwide• Siemens Healthcare Diagnostics, Inc.

Lipton Diet Green Tea (Pepsico) – Undeclared aspartame (2023)

Undeclared Allergen

Undeclared aspartame and lack of Phenylketonurics warning on immediate container (16.9fl.oz. bottle)

Class IIILow

FDAJul 8, 2023IN, KY, OH +1 more• Pepsico Inc

Procedural kits containing ultrasonic transmission gel, I... (Advance Medical Designs, Inc.) – mislabeling (2023)

Ultrasound gel mislabeled with inappropriate use.

Low

FDAJul 7, 2023Nationwide• Advance Medical Designs, Inc.

ASG-001; Ultrasound gel (Advance Medical Designs, Inc.) – mislabeling (2023)

Ultrasound gel mislabeled with inappropriate use.

Low

FDAJul 7, 2023Nationwide• Advance Medical Designs, Inc.

50-GEL20; Ultrasound gel (Advance Medical Designs, Inc.) – mislabeling (2023)

Ultrasound gel mislabeled with inappropriate use.

Low

FDAJul 7, 2023Nationwide• Advance Medical Designs, Inc.

TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only (Johnson & Johnson Surgical Vision, Inc.) – their is a potential that intraocular... (2023)

Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks.

Moderate

FDAJul 6, 2023Nationwide• Johnson & Johnson Surgical Vision, Inc.

Medtronic InterStim Ground Pad REF 041826 (Medtronic Neuromodulation) – lot of interstim self-adhesive ground... (2023)

Lot of InterStim Self-Adhesive Ground Pad is being recalled due to the product being labeled with the incorrect expiration date.

Low

FDAJul 6, 2023Nationwide• Medtronic Neuromodulation

TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00,... (Johnson & Johnson Surgical Vision, Inc.) – their is a potential that intraocular... (2023)

Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks.

Moderate

FDAJul 6, 2023Nationwide• Johnson & Johnson Surgical Vision, Inc.

Loteprednol Eye Suspension (Sun Pharma) – Potency Issue (2023)

Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.

Class IIILow

FDAJul 5, 2023Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Sunitinib Capsules (Teva) – Moisture Limit Failure (2023)

Failed Moisture Limits: Water (moisture) content above the approved product specifications.

Class IIModerate

FDAJul 5, 2023Nationwide• Teva Pharmaceuticals USA Inc

Sodium Chloride Injection (B. Braun) – Sterility Leak Risk (2023)

Lack of assurance of sterility: bags have the potential to leak.

Class IIModerate

FDAJul 5, 2023Nationwide• B. Braun Medical Inc.

Wireless Foot Switch distributed with Philips Allura Xper... (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands) – loss of availability of the wireless ... (2023)

Loss of availability of the wireless foot switch during procedures.

Moderate

FDAJun 30, 2023Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Vegan Lemon Pie Ice Cream (Sweet Alchemy) – Undeclared Coconut (2023)

Ice cream grab n go Pint containers' labels do not declare any ingredients including allergens Coconut and Wheat.

Class IIModerate

FDAJun 30, 2023IN, WA• Sweet Alchemy Ice Creamery, Inc

Dough or Die Ice Cream (Sweet Alchemy) – Undeclared Allergens (2023)

Ice cream grab n go Pint containers' labels do not declare any ingredients including allergens Egg, Milk, Soy, and Wheat.

Class IIModerate

FDAJun 30, 2023IN, WA• Sweet Alchemy Ice Creamery, Inc

Vegan Monkey Berry Bash Ice Cream (Sweet Alchemy) – Undeclared Coconut (2023)

Ice cream grab n go Pint containers' labels do not declare any ingredients including allergens Coconut.

Class IIModerate

FDAJun 30, 2023IN, WA• Sweet Alchemy Ice Creamery, Inc