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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 261–280 of 309 recalls

Disetronic Medical Systems, Inc.: Accu-Chek Ultraflex soft DUS 1 infusion set; 8 mm (60 cm)...

The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia

FDAMar 31, 2006Nationwide• Disetronic Medical Systems, Inc.

Disetronic Medical Systems, Inc.: Accu-Chek FlexLink 1 infusion set; 8/30; Ref number 04540...

The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia

FDAMar 31, 2006Nationwide• Disetronic Medical Systems, Inc.

Disetronic Medical Systems, Inc.: Accu-Chek Ultraflex 1-infusion set; 8 mm 24'' (60 cm); Ca...

The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia

1...12 131415 16

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FDAMar 31, 2006Nationwide• Disetronic Medical Systems, Inc.

Disetronic Medical Systems, Inc.: Disetronic Ultraflex 8/80 infusion set; Catalog number 44...

The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia

FDAMar 31, 2006Nationwide• Disetronic Medical Systems, Inc.

Disetronic Medical Systems, Inc.: Accu-Chek Ultraflex-2 infusion set; 8 mm 24'' (60 cm); Ca...

The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia

FDAMar 31, 2006Nationwide• Disetronic Medical Systems, Inc.

Disetronic Medical Systems, Inc.: Accu-Chek Ultraflex-8 infusion set; Catalog number 454477...

The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia

FDAMar 31, 2006Nationwide• Disetronic Medical Systems, Inc.

Disetronic Medical Systems, Inc.: Accu-Chek FlexLink Cannula 8; Ref number 04541219001. (D...

The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia

FDAMar 31, 2006Nationwide• Disetronic Medical Systems, Inc.

Disetronic Medical Systems, Inc.: Disetronic Ultraflex 10/110 infusion set; (Distributed o...

The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia

FDAMar 31, 2006Nationwide• Disetronic Medical Systems, Inc.

Disetronic Medical Systems, Inc.: Accu-Chek Ultraflex-10 infusion set; Catalog number 45447...

The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia

FDAMar 31, 2006Nationwide• Disetronic Medical Systems, Inc.

Disetronic Medical Systems, Inc.: Disetronic Ultraflex 8/110 infusion set; (Distributed ou...

The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia

FDAMar 31, 2006Nationwide• Disetronic Medical Systems, Inc.

Merit Convenience Kits (Merit Medical) - Sterility Concerns (2006)

Lack of Assurance of Sterility: Procedure kits contain a balanced salt solution that may be contaminated with endotoxins.

FDAFeb 24, 2006CT, MD, OH +1 more• Merit Medical Systems, Inc

Bard Access Systems, Inc: Groshong NXT ClearVue 4 Fr Single-Lumen PICC, Bard Access...

Multiple pages in the Instructions For Use booklet were missing print. Booklets were missing either pages 1,4,5,8,9,12,13,and 15, or 2,3,6,7,10,11,14, and 15. These pages contain product description, indications, contraindications, warnings, precautions, possible complications, and insertion instructions.

FDADec 20, 2005Nationwide• Bard Access Systems, Inc

Bard Access Systems, Inc: Groshong NXT 5 Fr. Dual-Lumen Reverse Taper PICC.

Multiple pages in the Instructions For Use booklet were missing print. Booklets were missing either pages 1,4,5,8,9,12,13,and 15, or 2,3,6,7,10,11,14, and 15. These pages contain product description, indications, contraindications, warnings, precautions, possible complications, and insertion instructions.

FDADec 20, 2005Nationwide• Bard Access Systems, Inc

Varian Medical Systems Inc: Varian brand Radiation Therapy Linear Accelerator VARiS; ...

The export of multi-static segment BrainLab M 3 MLC from VARiS Vision may produce undesirable result, which could lead to mistreatment.

FDANov 23, 2005AZ, AR, CA +33 more• Varian Medical Systems Inc

Merit Medical Systems, Inc: IntelliSystem II Thermal Dot Matrix printer 110 V adapter...

Dot matrix printer, as a component of a pressure monitoring system, may overheat and pose a fire hazard.

FDANov 7, 2005AL, IN, MD +8 more• Merit Medical Systems, Inc

Merit Medical Systems, Inc: Viceroy Inflation Syringe, 60mL, Sterile, Rx only.

Inflation device may not hold vacuum during angioplasty procedure.

FDAOct 21, 2005FL, OR, UT• Merit Medical Systems, Inc

Merit Medical Systems, Inc: Merit Custom Procedure Kit

Component of procedure kits may allow higher than desired amount of IV solution to be infused in to patient during pressure monitoring procedure.

FDASep 2, 2005MD, OR, VA +1 more• Merit Medical Systems, Inc

Varian Medical Systems Inc 3100 Hansen Way M/S E-210 Palo Alto CA 94304: Clinac (linear accelerator); Model 21EXS Silhouette Machi...

Emergency Off Switch located on the device may not function correctly resulting in the device remaining powered on after the switch is activated.

FDAMar 30, 2005CA, CT, IL +13 more• Varian Medical Systems Inc 3100 Hansen Way M/S E-210 Palo Alto CA 94304

Varian Medical Systems Inc 3100 Hansen Way M/S E-210 Palo Alto CA 94304-1030: Varian brand Clinac 600C (CD, EX) and Portal Vison with D...

Treatment beam may not completely pause while device changes field shape; Potential for mistreatment could occur.

FDAFeb 4, 2005IN• Varian Medical Systems Inc 3100 Hansen Way M/S E-210 Palo Alto CA 94304-1030

Alaris Medical Systems Inc: Model 8100 Series Medley Medication Safety System Pump Mo...

The device modification is being implemented in response to information received from the field regarding a specific method of misloading the medication administration tubing set into the infusion system pump module. To date there have been complaints from three (3) different customer locations.

FDANov 10, 2004Nationwide• Alaris Medical Systems Inc