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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 20521–20540 of 21319 recalls

Roche Diagnostics Corp.: Roche brand Reflotron GPT (ALT) 30 test strips; catalog #...

Coating defect may result is falsely decreased patient and/or control results.

FDAJul 14, 2004Nationwide• Roche Diagnostics Corp.

Smiths Medical ASD, Inc.: Thermovent 1200, Heat and Moisture Exchanger Catalog # 5...

Sterility of the device is compromised due to lack of package integrity

FDAJul 13, 2004Nationwide• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: ThermovenT 600, Heat and Moisture Exchangers Catalog #...

Sterility of the device is compromised due to lack of package integrity

FDAJul 13, 2004Nationwide• Smiths Medical ASD, Inc.

1...1025 102610271028 1029...1066

Page 1027 of 1066Next

Smiths Medical ASD, Inc.: Portex Thermovent T, Heat and Moisture Exchangers Catalo...

Sterility of the device is compromised due to lack of package integrity

FDAJul 13, 2004Nationwide• Smiths Medical ASD, Inc.

GE OEC Medical Systems, Inc: InstaTrak 3500 Navigation and Visualization System

Navigation inaccuracy may result if the headset registration method is used with the Axcess System Kit.

FDAJul 12, 2004CA, CT, KY +7 more• GE OEC Medical Systems, Inc

GE OEC Medical Systems, Inc: InstaTrak 3500 Plus Navigation and Visualization System

Navigation inaccuracy may result if the headset registration method is used with the Axcess System Kit.

FDAJul 12, 2004CA, CT, KY +7 more• GE OEC Medical Systems, Inc

GE OEC Medical Systems, Inc: ENTrak Plus Navigation and Visualization System

Navigation inaccuracy may result if the headset registration method is used with the Axcess System Kit.

FDAJul 12, 2004CA, CT, KY +7 more• GE OEC Medical Systems, Inc

Allen Medical Systems One Post Office Square: Neuro Adapter 2 used with the Berchtold B-810 Surgical Ta...

Neuro adapter may fail to engage and adequately clamp to the surgical table, resulting in movement

FDAJul 12, 2004SC• Allen Medical Systems One Post Office Square

GE OEC Medical Systems, Inc: ENTrak Navigation and Visualization System

Navigation inaccuracy may result if the headset registration method is used with the Axcess System Kit.

FDAJul 12, 2004CA, CT, KY +7 more• GE OEC Medical Systems, Inc

Boston Scientific Scimed: WALLSTENT Endoprostheses with UNISTEP Plus Delivery System.

Specific lots of the WALLSTENT Endoprosthesis with UNISTEP Plus Delivery System were packaged without one of the three required directions for use.

FDAJul 9, 2004Nationwide• Boston Scientific Scimed

Siemens Medical Solutions USA, Inc: AXIOM Sensis Programmable diagnostic computer, Model numb...

possible error calculating valve area with the AXIOM Sensis

FDAJul 9, 2004AL, AR, CA +22 more• Siemens Medical Solutions USA, Inc

B. Braun Medical, Inc.: Standard and Custom Spinal Trays with 5% Lidocaine Hydroc...

drug ampuls in kits contain particulates

FDAJul 6, 2004Nationwide• B. Braun Medical, Inc.

Multi-Surface Steam Cleaner (Euroflex) – Performance Issue (2004)

Fire/Burn Risk

Euroflex Monster 55 – 1600-Watt Multi-surface Steam Cleaner with Attachments. The steam cleaner has a red body and black cords and attachments. The word "monster" is written on the side of the steam cleaner.

CPSCJul 6, 2004Nationwide• Euroflex Americas Inc., of New York, N.Y.

Smiths Medical ASD, Inc.: 15963-20 SPINAL(DD) 22G WHITACRE W/DRUGS

Trays contain Hospira recalled 2ml drug ampuls of 5% Lidocaine Hydrochloride with 7.5% Dextrose Injection, (NDC 0074-4712-01, lot number 09-568-DK) Hospira, Inc. was recalling the 2ml drug vials of 5% Lidocaine Hydrochloride w/ 7.5% Dextrose lot number 09-568-DK). The drug is being recalled due to reports of particulate in the product.

FDAJul 2, 2004Nationwide• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: 15830-21 SPINAL(DD) 25G WHITACRE W/DRUGS

FDAJul 2, 2004Nationwide• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: 15545-20 SPINAL(DD) 25G W/DRUGS

FDAJul 2, 2004Nationwide• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: Smiths Medical ASD, Inc. Regional Anesthesia Trays contai...

FDAJul 2, 2004Nationwide• Smiths Medical ASD, Inc.

Stay Informed

Roche Diagnostics Corp. Recalls

Recall Summary

Roche Diagnostics Corp.: Roche brand Reflotron GPT (ALT) 30 test strips; catalog #...

Smiths Medical ASD, Inc.: Thermovent 1200, Heat and Moisture Exchanger Catalog # 5...

Smiths Medical ASD, Inc.: ThermovenT 600, Heat and Moisture Exchangers Catalog #...

Smiths Medical ASD, Inc.: Portex Thermovent T, Heat and Moisture Exchangers Catalo...

GE OEC Medical Systems, Inc: InstaTrak 3500 Navigation and Visualization System

GE OEC Medical Systems, Inc: InstaTrak 3500 Plus Navigation and Visualization System

GE OEC Medical Systems, Inc: ENTrak Plus Navigation and Visualization System

Allen Medical Systems One Post Office Square: Neuro Adapter 2 used with the Berchtold B-810 Surgical Ta...

GE OEC Medical Systems, Inc: ENTrak Navigation and Visualization System

Boston Scientific Scimed: WALLSTENT Endoprostheses with UNISTEP Plus Delivery System.

Siemens Medical Solutions USA, Inc: AXIOM Sensis Programmable diagnostic computer, Model numb...

B. Braun Medical, Inc.: Standard and Custom Spinal Trays with 5% Lidocaine Hydroc...

Multi-Surface Steam Cleaner (Euroflex) – Performance Issue (2004)

Smiths Medical ASD, Inc.: 15963-20 SPINAL(DD) 22G WHITACRE W/DRUGS

Smiths Medical ASD, Inc.: 15830-21 SPINAL(DD) 25G WHITACRE W/DRUGS

Smiths Medical ASD, Inc.: 15545-20 SPINAL(DD) 25G W/DRUGS

Smiths Medical ASD, Inc.: Smiths Medical ASD, Inc. Regional Anesthesia Trays contai...

Smiths Medical ASD, Inc.: 15548-20 REG ANES W/DRUGS

Smiths Medical ASD, Inc.: 15568-20 SPINAL(DD) 25G W/DRUGS

Smiths Medical ASD, Inc.: 15955-21 SPINAL(DD) 25G WHITACRE W/DRUGS