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Combat Medical Systems, LLC

Combat Medical Systems, LLC Recalls

All product recalls associated with Combat Medical Systems, LLC.

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Recall Summary

Total Recalls

1000

Past Year

353

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 1481–1500 of 3680 recalls

Whole Blood Transfusion Set (Combat Medical) – Needle Defect (2020)

There is the potential of a bent or disconnected needle in one of the components of the convenience kits.

Moderate

FDADec 23, 2020Nationwide• Combat Medical Systems, LLC

Whole Blood Transfusion Set (Combat Medical) – Needle Defect (2020)

There is the potential of a bent or disconnected needle in one of the components of the convenience kits.

Moderate

FDADec 23, 2020Nationwide• Combat Medical Systems, LLC

Low Titer Blood Collection Set (Combat Medical) – Needle Defect (2020)

There is the potential of a bent or disconnected needle in one of the components of the convenience kits.

Moderate

FDADec 23, 2020Nationwide

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• Combat Medical Systems, LLC

Whole Blood Administration Set (Combat Medical) – Needle Defect (2020)

There is the potential of a bent or disconnected needle in one of the components of the convenience kits.

Moderate

FDADec 23, 2020Nationwide• Combat Medical Systems, LLC

Infinity Acute Care System (Draegar) – Patient Monitor Reboot (2020)

The Infinity M540 patient monitor may randomly reboot due to an error to correctly transmit and read the header data of files in the memory of the device. Under this situation, the device will try to reboot to mitigate the error. The device will be available again for use within 30 seconds. If this error continues and the M540 reboots three times in a time span of 10 minutes, it will enter a fail-state. A fail-state will annunciate itself with a continuous sound to alert the user. The M540 will reset to factory default and the user can manually configure and readmit the patient to continue patient monitoring.

Moderate

FDADec 23, 2020Nationwide• Draegar Medical Systems, Inc.

HDL-C/LDL-C Calibrator (Fujifilm) – Label Concentration Error (2020)

FUJIFILM has become aware that incorrect concentration values were printed on the bottle label for all product manufactured as part of Lot EL629. This may result incorrect results when used in testing.

Moderate

FDADec 22, 2020Nationwide• Fujifilm Medical Systems U.S.A., Inc.

Harmony Referral System (Topcon) – Patient ID Mismatch (2020)

Harmony RS integrations with Topcon equipment, TRC NW-400 and the Signal Camera, allowed user input of non-unique patient IDs that caused multiple patient records and images to be combined under the first generated record

Moderate

FDADec 18, 2020AZ, MO, NY +3 more• Topcon Medical Systems, Inc.

Reliance Vision Washer (Steris) – Electrical Contactor Risk (2020)

Fire/Burn Risk

The electrical contactor component present in the drying chamber of the Reliance Vision Single-Chamber Washer/Disinfector may malfunction, potentially leading to the heating elements in the drying chamber to overheat, eventually resulting in smoke and/or fire.

High

FDADec 11, 2020Nationwide• Steris Corporation

Synapse PACS Software (Fujifilm) – Measurement Update Problem (2020)

The software does not update measurements and calculations in the Clinical Reporting Application (CRA) when the ventricular trace is changed in the study by a different user.

Moderate

FDADec 11, 2020Nationwide• Fujifilm Medical Systems U.S.A., Inc.

Canon Interventional Angiography System (Canon) – Table Tilt Fault (2020)

System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose.

High

FDADec 8, 2020Nationwide• Canon Medical System, USA, INC.

Vis-U-All High Temp 5x15 Pouch (Steris) – Ink Migration Issue (2020)

Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s) contained within the pouch

Low

FDADec 2, 2020Nationwide• Steris Corporation

Stay Informed

Combat Medical Systems, LLC Recalls

Recall Summary

Whole Blood Transfusion Set (Combat Medical) – Needle Defect (2020)

Whole Blood Transfusion Set (Combat Medical) – Needle Defect (2020)

Low Titer Blood Collection Set (Combat Medical) – Needle Defect (2020)

Whole Blood Administration Set (Combat Medical) – Needle Defect (2020)

Infinity Acute Care System (Draegar) – Patient Monitor Reboot (2020)

HDL-C/LDL-C Calibrator (Fujifilm) – Label Concentration Error (2020)

Harmony Referral System (Topcon) – Patient ID Mismatch (2020)

Reliance Vision Washer (Steris) – Electrical Contactor Risk (2020)

Synapse PACS Software (Fujifilm) – Measurement Update Problem (2020)

Canon Interventional Angiography System (Canon) – Table Tilt Fault (2020)

Vis-U-All High Temp 5x15 Pouch (Steris) – Ink Migration Issue (2020)

Vis-U-All High Temperature Tubing (Steris) – Ink Migration Issue (2020)

Vis-U-All High Temp 7.5x13.5 Pouch (Steris) – Ink Migration Issue (2020)

Vis-U-All High Temp 4x11 Pouch (Steris) – Ink Migration Issue (2020)

Vis-U-All High Temp 7.5x13 Pouch (Steris) – Ink Migration Issue (2020)

Vis-U-All High Temp 4.5x11 Pouch (Steris) – Ink Migration Issue (2020)

Vis-U-All High Temp 5.5x10 Pouch (Steris) – Ink Migration Issue (2020)

Vis-U-All High Temp 6x10 Pouch (Steris) – Ink Migration Issue (2020)

Vis-U-All High Temp 8x16 Pouch (Steris) – Ink Migration Issue (2020)

Vis-U-All High Temp 13x18 Pouch (Steris) – Ink Migration Issue (2020)