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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

589

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 4521–4540 of 10393 recalls

Atellica CH Total Bilirubin Assay (Siemens) – eltrombopag bias (2020)

Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy

Moderate

FDAFeb 13, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

ADVIA Chemistry Total Bilirubin Assay (Siemens) – eltrombopag bias (2020)

Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy

Moderate

FDAFeb 13, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Banana Pudding Ice Cream (Hunter Farms) – undeclared soy (2020)

Undeclared Soy

The firm was notified that the product contains undeclared soy.

Class II

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Moderate

FDAFeb 11, 2020IN, NC• Harris Teeter Supermarkets, LLC dba Hunter Farms

Donor Human Milk (Mothers' Milk Bank) – foreign object (2020)

Foreign object found in a bottle.

Class IIModerate

FDAFeb 11, 2020IN, LA• Mothers' Milk Bank of Louisiana at Ochsner Baptist

McKesson Cardiology ECG Management (Change Healthcare) – heart rate estimation (2020)

Inaccurate estimation of the heart rate may occur in instances where the user is estimating heart rate counting grid squares using the Sequential ECG format

Low

FDAFeb 10, 2020Nationwide• CHANGE HEALTHCARE CANADA COMPANY

Pelican Flashlights 9410/9415 (Pelican) – equipment issue (2020)

Fire/Burn Risk

Ferrara Fire Apparatus, Inc. (Ferrara) is recalling certain Pelican Flashlights, models 9410 and 9415, supplied with various emergency response vehicles. The battery pack within the flashlights may explode while charging.

High

NHTSAFeb 7, 2020Nationwide• PELICAN FLASHLIGHTS

Desmopressin Tablets (American Health) – Missing Desiccant (2020)

GMP Deviations: Product bottle may be absent of desiccant.

Class IIModerate

FDAFeb 7, 2020Nationwide• American Health Packaging

Desmopressin Tablets (American Health) – Missing Desiccant (2020)

GMP Deviations: Product bottle may be absent of desiccant.

Class IIModerate

FDAFeb 7, 2020Nationwide• American Health Packaging

Sump Pumps (Utilitech) – Fire hazard (2020)

Fire/Burn Risk

This recall involves pedestal sump pumps that are used in residential de-watering. The sump pumps are sold under three brand names: Utilitech, Do It and Star Water Systems. The model and manufacture date codes are printed on the nameplate on the sump pump. Only the following model numbers, date codes and UPC codes of the pumps are included in the recall: Brand Name Model # Manufacturing Date Codes UPC Codes Utilitech #148009 1017 - 0219 054757098483 Do It #433063 0214 - 0219 009326405087 Star Water Systems #3CEH 0715 - 0219 054757000721

High

CPSCFeb 6, 2020Nationwide• Junhe Pumps Holding Co., Ltd., of China

Walk Behind Leaf Blowers (DR Power) – Projectile hazard (2020)

This recall involves DR Walk Behind Leaf Blowers, including DR PREMIER 1200, DR PRO 2000 and DR PRO 2000SP. The blowers are three-wheeled walk behind blowers with an orange circular metal face with a black center with "DR" printed on the front. The model number is printed on the front left side of the main impeller housing and on the serial number label located on the back right side of the main impeller housing. Only the following models are included in the recall: Product name Model Number DR PREMIER 1200 Walk Behind Leaf Blower WB13010DMN DR PRO 2000 Walk Behind Leaf Blower WB15020DMN DR PRO 2000 Walk Behind Leaf Blower WB15020DEN DR PRO 2000SP Walk Behind Leaf Blower WB17020DEN

High

CPSCFeb 6, 2020Nationwide• Country Home Products Inc., d/b/a DR Power Equipment, of South Burlington, Vt.

Prismaflex System (Baxter) – connector safety information (2020)

Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system.

Low

FDAFeb 6, 2020IN, PR• Baxter Healthcare Corporation

IMMULITE 2000 Estradiol (Siemens) – result discrepancy (2020)

Due to high discordant Estradiol results which.potentially affects all patient populations, A falsely elevated estradiol level could lead a clinician to misinterpret a patient as pre-menopausal when truly post- menopausal. This may lead to delayed initiation of a potentially beneficial drug and/or administration of an unnecessary drug in the treatment for hormone receptor positive advanced or metastatic breast cancer.

Moderate

FDAFeb 5, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

IMMULITE 1000 Estradiol (Siemens) – result discrepancy (2020)

Moderate

FDAFeb 5, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

TRUMATCH Orthognathics Kit (Materialise) – incorrect plate labeling (2020)

Custom surgical kits contain a plate different than indicated by the package labeling.

Low

FDAFeb 3, 2020NY• Materialise N.V. Technologielaan 15 Heverlee Belgium

TRUMATCH Orthognathic Kit (Materialise) – incorrect plate labeling (2020)

Custom surgical kits contain a plate different than indicated by the package labeling.

Low

FDAFeb 3, 2020NY• Materialise N.V. Technologielaan 15 Heverlee Belgium

UST-2265-2 Probe (Hitachi) – inner cable miswiring (2020)

These 18 probes may have mis-wiring in the inner cables, causing decreased sensitivity and thus resulting in lower peak velocity readings.

Low

FDAJan 31, 2020CA, FL, GA +5 more• Hitachi Medical Systems America Inc

Presource Procedure Packs (Cardinal Health) – gown manufacturing issue (2020)

The kits contained recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection.

Moderate

FDAJan 31, 2020Nationwide• Cardinal Health 200, LLC

CareLink 2090 Programmer (Medtronic) – cyber vulnerability (2020)

Medtronic Conexus Telemetry has been determined to contain two primary cyber vulnerabilities: improper access control and the cleartext transmission of sensitive information.

Low

FDAJan 30, 2020Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

CareLink Encore Programmer (Medtronic) – cyber vulnerability (2020)

Medtronic Conexus Telemetry has been determined to contain two primary cyber vulnerabilities: improper access control and the cleartext transmission of sensitive information.

Low

FDAJan 30, 2020Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Clonidine Tablets (Unichem) – Benzophenone Migration (2020)

Failed Impurities/Degredation Specifications: This recall is initiated as a precautionary measure due to potential migration of Benzophenone at very low level into product from container label.

Class IIILow

FDAJan 29, 2020Nationwide• UNICHEM PHARMACEUTICALS USA INC