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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

592

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 7701–7720 of 10393 recalls

Siemens Healthcare Diagnostics, Inc: External power supply adaptors that accompany Clinitek St...

The external power supply for the Clintek Status analyzer, which is provided separately, is damaged. It can result in an electric shock to the User.

Class IIModerate

FDASep 19, 2014Nationwide• Siemens Healthcare Diagnostics, Inc

Siemens Healthcare Diagnostics, Inc: External power supply adaptors that accompany Clinitek St...

The external power supply for the Clintek Status analyzer, which is provided separately, is damaged. It can result in an electric shock to the User.

Class IIModerate

FDASep 19, 2014Nationwide• Siemens Healthcare Diagnostics, Inc

Orthohelix Surgical Designs Inc: MaxLock Extreme Mod-Foot Concave Reamer; Individually pac...

1...384 385386387 388...520

Page 386 of 520Next

Incorrect sizing was being laser etched on the MaxLock Extreme Mod-Foot Concave Reamer

Class IIModerate

FDASep 19, 2014IN, MI, MO +10 more• Orthohelix Surgical Designs Inc

Siemens Healthcare Diagnostics: IMMULITE /IMMULITE 1000 Systems COR Cortisol, REF/Catalog...

Customer complaints were received for positive bias reported on the controls used on the IMMULITE /IMMULITE 1000 on the Cortisol Assay reagent lots IMMULITE /IMMULITE 1000 (LKCO1) Lots 381,382 and 383 . Subsequently, the firm confirmed a positive bias on the IMMULITE/IMMULITE 1000 (LKCO1) Lots 381, 382 and 383.

Class IIModerate

FDASep 19, 2014Nationwide• Siemens Healthcare Diagnostics

Baxter Healthcare Corp: Baxter 2B8011 Empty INTRA VIA Container with PVC Ports, ...

Particulate matter found inside the fluid path.

Class IHigh

FDASep 16, 2014Nationwide• Baxter Healthcare Corp

Baxter Healthcare Corp: Baxter 2B8013 Empty INTRA VIA Container with PVC Ports (...

Particulate matter found inside the fluid path.

Class IHigh

FDASep 16, 2014Nationwide• Baxter Healthcare Corp

Siemens Healthcare Diagnostics, Inc: ADVIA Centaur¿¿ Systems HBc Total (HBcT) Kit. For In Vitr...

Increased imprecision and positive bias is observed with patient samples and negative controls and can result in an increase in initial reactive results.

Class IIModerate

FDASep 15, 2014Nationwide• Siemens Healthcare Diagnostics, Inc

Siemens Healthcare Diagnostics, Inc: Siemens ADVIA Centaur¿ Systems HBc Total (HBcT), Reagent....

Increased imprecision and positive bias is observed with patient samples and negative controls and can result in an increase in initial reactive results.

Class IIModerate

FDASep 15, 2014Nationwide• Siemens Healthcare Diagnostics, Inc

Siemens Healthcare Diagnostics, Inc: ADVIA Centaur¿ and ADVIA Centaur¿ XP and ADVIA Centaur¿ C...

Stability of the ADVIA Centaur Cleaning Solution is not assured

Class IIILow

FDASep 12, 2014Nationwide• Siemens Healthcare Diagnostics, Inc

Potassium Chloride Injection (Baxter) – Product Mispack (2014)

Correct Labeled Product Mispack: Shipping cartons labeled as containing Potassium Chloride injection actually contained bags labeled and containing Gentamicin Sulfate injection inside.

Class IIModerate

FDASep 8, 2014Nationwide• Baxter Healthcare Corp

Twix Unwrapped Bites (Mars) – Undeclared Allergens (2014)

Undeclared Nuts

Mars Chocolate North is recalling Twix Brand Unwrapped Bites 7 oz. pouch due to undeclared peanuts and eggs.

Class IHigh

FDASep 5, 2014Nationwide• Mars Chocolate North America

GE Healthcare, LLC: GE Healthcare Precision 500D, Classical R&F System. Pr...

GE Healthcare has become aware of a potential safety issue involving missing screws used for mounting the overhead Video Monitor to the tray assembly on a single monitor suspension. This issue affects the Precision 500D X-ray imaging systems.

Class IIModerate

FDASep 5, 2014Nationwide• GE Healthcare, LLC

Jalapeno Bagels (Wholesome Harvest) – Contamination (2014)

Wholesome Harvest Baking, Inc. ("WHB"), formerly Maple Leaf Bakery, Inc., of Chicago is initiating a voluntary recall of frozen in-store bakery Jalapeno Bagel based on reports of foreign material (glass pieces and stones) in product.

Class IIModerate

FDASep 5, 2014Nationwide• Wholesome Harvest Baking, Inc.

GE Healthcare, LLC: Innova IGS 540 Indicated for use for patients from new...

Loss of imaging - affected devices may experience a loss of real-time interventional imaging and/or gantry motion due to the Electromagnetic (EM) sensitivity of the grid detection mechanism.

Class IIModerate

FDASep 4, 2014CA, CO, FL +2 more• GE Healthcare, LLC

GE Healthcare, LLC: Innova 4100IQ Indicated for use in generating fluorosc...

Loss of imaging - affected devices may experience a loss of real-time interventional imaging and/or gantry motion due to the Electromagnetic (EM) sensitivity of the grid detection mechanism.

Class IIModerate

FDASep 4, 2014CA, CO, FL +2 more• GE Healthcare, LLC

GE Healthcare, LLC: Discovery IGS 740 Indicated for use for patients from ...

Loss of imaging - affected devices may experience a loss of real-time interventional imaging and/or gantry motion due to the Electromagnetic (EM) sensitivity of the grid detection mechanism.

Class IIModerate

FDASep 4, 2014CA, CO, FL +2 more• GE Healthcare, LLC

Baxter Healthcare Corp.: SPECTRUM Pump, Model No. 35700BAX. Intended to be use...

One Service Technician may not have correctly serviced specific Sigma Spectrum Infusion Pumps according to established procedures during the time period of 5/5/2014 through 6/3/2014.

Class IIModerate

FDASep 3, 2014Nationwide• Baxter Healthcare Corp.

HIGHLAND CARRIER Equipment Recall: EQUIPMENT:OTHER:LABELS

Trimas Corporation (Trimas) is recalling certain model Highland-brand Universal Telescopic Bar Carriers (part numbers 2508500 and 25085), Universal Car Roof Top Basket Carriers (part number 35036) and Multi-Purpose Roof Top Bar Carriers (part numbers 2005200 and 20052), and Reese-brand Carry Power Multi-Purpose Bar Carriers (part numbers 13907 and 1390700) and Carry Power Roof Top Multi-Purpose Steel Basket Carriers (part number 1390900). The affected carriers may have inadvertently been packaged without the proper warning labels advising consumers not use the carriers with cargo bags, cargo baskets, cargo boxes or rooftop accessories.

NHTSASep 2, 2014Nationwide• HIGHLAND

Siemens Healthcare Diagnostics, Inc.: Dimension Vista¿ Mass CKMB Isoenzyme Calibrator (MMB CAL)...

Siemens Healthcare Diagnostics has determined that Dimension Vista® Mass CKMB Isoenzyme Calibrator (MMB CAL) shows drift during routine stability monitoring that exceeds our acceptance criteria for drift over the shelf life of this product. Siemens has observed drift from 3% to 12% at MMB concentrations across the assay range. Depending on quality control limits, this drift may not have been d

Class IIModerate

FDAAug 28, 2014Nationwide• Siemens Healthcare Diagnostics, Inc.

Bunk Beds (American Woodcrafters) – fall hazard (2014)

This recall involves Cottage Retreat II bunk beds with a side ladder. The white finish beds were sold in twin over twin, and twin over full combinations. American Woodcrafters, Made in Indonesia and SKU number 6310-9771 are printed on a label attached to the inside of one of the four rails.

CPSCAug 28, 2014Nationwide• American Woodcrafters, of High Point, N.C.