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Roche Diagnostics Corp.

Roche Diagnostics Corp. Recalls

All product recalls associated with Roche Diagnostics Corp..

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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 17461–17480 of 21320 recalls

Roche Diagnostics Corp.: Roche MagNA Pure LC Workstation; Product Numbers: 1223693...

Laceration Risk

Protruding screw threads may cut the user when cleaning the interior of the instrument.

FDAFeb 9, 2009Nationwide• Roche Diagnostics Corp.

Siemens Medical Solutions USA, Inc: syngo Imaging model number 10014063. Affected systems are...

An issue concerning archived image data that is sporadically saved with corrupted data may occur. This issue may occur when syngo Imaging is configured to archive image data on a network file system (NFS) connected via a connected archive (Mount Point Solution).

FDAFeb 9, 2009Nationwide• Siemens Medical Solutions USA, Inc

Medtronic Sofamor Danek USA Inc: Medtronic INTREPID Spinal System SPACER, 32X23, 8 DEG, Si...

The firm received complaints regarding the use of the product in patients with poor bone quality, translational instability, difficulty implanting the cover plate and case of cover plate detachment.

1...872 873874875 876...1066

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FDAFeb 6, 2009Nationwide• Medtronic Sofamor Danek USA Inc

Medtronic Inc: Medtronic STREAMLINE Bipolar Temporary Myocardial Pacing ...

Medtronic is recalling one lot of STREAMLINE Bipolar Myocardial Temporary Pacing Leads, Model 6495, Lot JGD880205F. This lot of product contains incorrect inner pouch labeling, instead of 6495 it is labeled 6500. The outer carton, shelf box labeling, and instructions for use are correct, and the actual product shipped was consistent with the product ordered. No adverse patient effects have b

FDAFeb 6, 2009Nationwide• Medtronic Inc

Digisonics, Inc: Digisonics, Digiview and ERS software releases 3.6.44, 3....

Left ventricle volume was inaccurate when the volumes were measured from images having different scales.

FDAFeb 6, 2009Nationwide• Digisonics, Inc

Computerized Medical Systems Inc: Focal Radiation Treatment Planning System, Focal Release...

Focal Software: if individual MLC leaf position edits are made, the original MLC aperture is retained. A subsequent aperture edit should not affect the MLC leaf positions however it was found that instead the leaves will then snap (unintentionally) back to the original aperture. Also, if the patient is sent to XiO after the MLC is edited, an isocenter shift made in XiO will also cause the MLCs to

FDAFeb 6, 2009Nationwide• Computerized Medical Systems Inc

Medtronic Sofamor Danek USA Inc: Medtronic SOFAMOR DANEK INTREPID SPINAL SYSTEM, 5.5MM TAP...

The firm received complaints regarding the use of the product in patients with poor bone quality, translational instability, difficulty implanting the cover plate and case of cover plate detachment.

FDAFeb 6, 2009Nationwide• Medtronic Sofamor Danek USA Inc

Respironics: Remstar Pro M-Series Heated Humidifier System.

Malfunction of the J3 connection between the Heater Plate Main printed circuit assembly (PCA) and the heater plate may have an intermittent connection which may lead to excessive heat build-up on the humidifier PCA.

FDAFeb 5, 2009AZ, IN, KY +5 more• Respironics

Cyberkinetics Neurotechnology Systems, Inc.: Cyberkinetics Inserter Wand & V2 Trigger Assembly, Expira...

Sterility of product cannot be assured

FDAFeb 4, 2009Nationwide• Cyberkinetics Neurotechnology Systems, Inc.

Medtronic Spine LLC, formerly Kyphon Inc: KyphX Xpander Inflatable Bone Tamp, size 15/3, Catalog Nu...

Product not sterile: 10 units were released for distribution without undergoing sterilization process.

FDAFeb 4, 2009FL, IN, OH• Medtronic Spine LLC, formerly Kyphon Inc

Toshiba American Medical Systems Inc: Toshiba Aquilion ONE CT SystemTSX-301 A/2D

ECG Gated Dynamic Volume Prospective scan may stop if preset eXam Plan is confirmed and CTA On is changed to CTA OFF, due to exposure control PWB.

FDAFeb 3, 2009Nationwide• Toshiba American Medical Systems Inc

Ethicon, Inc. US: Orthocord Blue Braided Composite Suture, DePuy Mitek, A J...

Sterility Issue: The firm decided to remove the product because it cannot assure the sterility of the products due to a failure in the sterilization process.

FDAFeb 2, 2009PR• Ethicon, Inc. US

Ethicon, Inc. US: PDS Plus Antibacterial (polydioxanone) Suture Sutures ar...

Sterility Issue: The firm decided to remove the product because it cannot assure the sterility of the products due to a failure in the sterilization process.

FDAFeb 2, 2009PR• Ethicon, Inc. US

Zoe Medical Incorporated: The Well@Home Monitor by Patient Care technologies Model ...

Touch panel may become unresponsive.

FDAFeb 2, 2009Nationwide• Zoe Medical Incorporated

GE Medical Systems, LLC: AdvantageSim MD versions 7.4 through 7.6, Model 5160092. ...

It was reported by a customer site that when using Advantage Sim MD on Advantage Workstation, the series could be incorrectly labeled in image view when multiple series of an exam are loaded simultaneously in Advantage Sim MD and if their series dates are different. A mismatch of series label for structure sets may lead to under-treatment of a tumor due to too small coverage of volume treated.

FDAFeb 2, 2009AL, AZ, CA +38 more• GE Medical Systems, LLC

Ethicon, Inc. US: MONOCRYL (poliglecaprone 25 ) Suture, Ethicon Inc., A Joh...

Sterility Issue: The firm decided to remove the product because it cannot assure the sterility of the products due to a failure in the sterilization process.

FDAFeb 2, 2009PR• Ethicon, Inc. US

Sunrise Medical Inc: Manual Wheelchairs with Transit System Option, Model: Qui...

The stabilizer bar was inadvertently omitted during the manufacturing process.

FDAFeb 2, 2009Nationwide• Sunrise Medical Inc

Ethicon, Inc. US: Coated VICRYL Plus Antibacterial (polyglactin 910) Suture...

Sterility Issue: The firm decided to remove the product because it cannot assure the sterility of the products due to a failure in the sterilization process.

FDAFeb 2, 2009PR• Ethicon, Inc. US

Ethicon, Inc. US: Orthocord Suture, DePuy Mitek, a Johnson & Johnson Compan...

Sterility Issue: The firm decided to remove the product because it cannot assure the sterility of the products due to a failure in the sterilization process.

FDAFeb 2, 2009PR• Ethicon, Inc. US

Ethicon, Inc. US: MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture; E...

Sterility Issue: The firm decided to remove the product because it cannot assure the sterility of the products due to a failure in the sterilization process.

FDAFeb 2, 2009PR• Ethicon, Inc. US