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Disetronic Medical Systems, Inc.

Disetronic Medical Systems, Inc. Recalls

All product recalls associated with Disetronic Medical Systems, Inc..

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Recall Summary

Total Recalls

309

Past Year

15

Class I (Serious)

3

Most Recent

Oct 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 161–180 of 309 recalls

Disetronic Medical Systems, Inc.: Roche ACCU-CHEK Spirit insulin pump. Part numbers 454049...

The "up" and "down" buttons, which are used for changing the program in the menu or to administer additional insulin through a bolus delivery, may experience intermittent failure or completely cease to operate.

FDAApr 30, 2009Nationwide• Disetronic Medical Systems, Inc.

Cardiovascular Systems, Inc.: Diamondback 360 Orbital Atherectomy Device, 1.50 LT Class...

CSI is correcting (8) packages of Diamondback 360 due to a missing "Use By Date" on the device labeling. The labelling should have been a 12 month shelf life (2010-02) rather than no information for shelf life. The units affected by this correction are sterilized products, and CSI believes that there is no immediate risk to health associated with these distributed products recognizing the valid s

FDAApr 16, 2009Nationwide• Cardiovascular Systems, Inc.

Merit Medical Systems, Inc.: 7F Prelude Short Sheath Introducer, 4CM in Length with Ma...

1...7 8910 11...16

Page 9 of 16Next

External tubing may separate during use, allowing blood loss.

FDAApr 14, 2009CA, CO, GA +4 more• Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: 5F Prelude Short Sheath Introducer, 4CM in Length with Ma...

External tubing may separate during use, allowing blood loss.

FDAApr 14, 2009CA, CO, GA +4 more• Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: Prelude Short Sheath Introducer, Carolina Kidney and Endo...

External tubing may separate during use, allowing blood loss.

FDAApr 14, 2009CA, CO, GA +4 more• Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: 8F Prelude Short Sheath Introducer, 4CM in Length with Ma...

External tubing may separate during use, allowing blood loss.

FDAApr 14, 2009CA, CO, GA +4 more• Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: 6F Prelude Short Sheath Introducer, 4CM in Length with Ma...

External tubing may separate during use, allowing blood loss.

FDAApr 14, 2009CA, CO, GA +4 more• Merit Medical Systems, Inc.

Cardiovascular Systems, Inc.: Diamondback 360, CSI ViperWire Orbital Atherectomy Guide ...

CSI is recalling 10 devices due to a mislabeling of the shelf life as shown on the device labeling. The labeling shown on the affected devices represents a 24 month shelf life rather than a 6 month shelf life that should have been indicated.

FDAMar 16, 2009Nationwide• Cardiovascular Systems, Inc.

Trumpf Medical Systems, Inc.: ILED Surgical Light, Model numbers: ILED3, ILED5 and ILED5K

Cracks may form around the screw connections of the cover plates causing brittleness, which may lead to fragments breaking off and falling into the operating area.

FDAFeb 27, 2009Nationwide• Trumpf Medical Systems, 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

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

Merit Medical Systems, Inc.: Custom Angiographic Kit, K09-MS3084, Sterile EO, Merit Me...

A manufacturing defect may prevent adequate sterilization of the entire device.

FDAJan 29, 2009Nationwide• Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: University Health System Custom Cardiac Cath Pack, K09T-0...

A manufacturing defect may prevent adequate sterilization of the entire device.

FDAJan 29, 2009Nationwide• Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: Jeanes Hospital Custom Cath Procedure Tray, K09T-08945, S...

A manufacturing defect may prevent adequate sterilization of the entire device.

FDAJan 29, 2009Nationwide• Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: Custom Cardiac Cath Pack Kit, K09-08945, Sterile EO, Meri...

A manufacturing defect may prevent adequate sterilization of the entire device.

FDAJan 29, 2009Nationwide• Merit Medical Systems, Inc.

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

Focal: the couch position can be moved between scans of the same CT study. When the images are imported into Focal, the software is not checking the DICOM Image Position (Patient) tag and therefore is not aligning the images sets if there are different couch positions indicated. A shift between image sets will exist of the same amount that the CT couch was moved.

FDAJan 19, 2009Nationwide• Computerized Medical Systems Inc

Toshiba American Medical Systems Inc: Aquilion 64 CT System; Model number TSX-101 A/D The pro...

Toshiba America Medical Systems Inc (TAMS) has initiated a field correction on the Aquilion 32 CT Scanners due to the potential for the bolus tracking software (SureStart) to cause delay of the helical scan, up to 10 seconds, when large volumes of data are being reconstructed on the secondary console.

FDAJan 8, 2009Nationwide• Toshiba American Medical Systems Inc

Toshiba American Medical Systems Inc: Aquilion 32 CT System; Model number TSX-101 A/E The pro...

Toshiba America Medical Systems Inc (TAMS) has initiated a field correction on the Aquilion 32 CT Scanners due to the potential for the bolus tracking software (SureStart) to cause delay of the helical scan, up to 10 seconds, when large volumes of data are being reconstructed on the secondary console.

FDAJan 8, 2009Nationwide• Toshiba American Medical Systems Inc

Computerized Medical Systems Inc: XiO Radiation Treatment Planning System, XiO Release 4.3....

XiO Software: Under certain conditions, when the port shape is altered, dose is not recalculated. The port-change flag is not being set correctly when the port shape is regenerated. The dose distribution will not match the blocking displayed and the mis-match might not be obvious. Monitor Unit calculations will also be based on an incorrect dose distribution. This problem has existed since Re

FDADec 9, 2008Nationwide• Computerized Medical Systems Inc

C.R. Bard Access Systems, Inc: Bard Access Systems, Inc., Bard* Deluxe Guidewire PEG (Pe...

Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal during use, necessitating retrieval of the remaining piece.

FDADec 4, 2008Nationwide• C.R. Bard Access Systems, Inc