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Brainlab AG Olof-palme-str. 9 Munich Germany

Brainlab AG Olof-palme-str. 9 Munich Germany Recalls

All product recalls associated with Brainlab AG Olof-palme-str. 9 Munich Germany.

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Recall Summary

Total Recalls

1000

Past Year

566

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 1341–1360 of 7756 recalls

Cirq Arm System 2.0 (Brainlab) – Mechanical Instability (2023)

Risk of mechanical instability due to potential manufacturing error of the device

FDAMar 2, 2023TX• Brainlab AG Olof-palme-str. 9 Munich Germany

Clobazam 10mg Tablets (Breckenridge) – CGMP Contamination Risk (2023)

CGMP Deviations: Potential risk of Cross Contamination

Class IIModerate

FDAMar 2, 2023Nationwide• Breckenridge Pharmaceutical, Inc

Alprazolam 0.25mg Tablets (Breckenridge) – CGMP Cross Contamination (2023)

CGMP Deviations: Potential risk of Cross Contamination

Class IIModerate

FDA

1...66 676869 70...388

Page 68 of 388Next

Mar 2, 2023

Nationwide

• Breckenridge Pharmaceutical, Inc

Clobazam 20mg Tablets (Breckenridge) – CGMP Contamination Risk (2023)

CGMP Deviations: Potential risk of Cross Contamination

Class IIModerate

FDAMar 2, 2023Nationwide• Breckenridge Pharmaceutical, Inc

Alprazolam 1mg Tablets (Breckenridge) – CGMP Cross Contamination (2023)

CGMP Deviations: Potential risk of Cross Contamination

Class IIModerate

FDAMar 2, 2023Nationwide• Breckenridge Pharmaceutical, Inc

Alprazolam 0.5mg Tablets (Breckenridge) – CGMP Cross Contamination (2023)

CGMP Deviations: Potential risk of Cross Contamination

Class IIModerate

FDAMar 2, 2023Nationwide• Breckenridge Pharmaceutical, Inc

Alprazolam Tablets (Breckenridge) – CGMP Contamination Risk (2023)

CGMP Deviations: Potential risk of Cross Contamination

Class IIModerate

FDAMar 2, 2023Nationwide• Breckenridge Pharmaceutical, Inc

Leksell Stereotactic System Manuals (Elekta) – Incorrect IFU (2023)

The incorrect IFU was distributed with the devices.

FDAMar 1, 2023Nationwide• Elekta Instrument AB Kungstensgatan 18 Stockholm Sweden

BioPlex 2200 APLS IgM Pack (Bio-Rad) – Reagent Conjugate Mismatch (2023)

APLS IgM reagent kits were packaged with the incorrect conjugate, which could lead to an increase in false-positive and false-negative results.

FDAFeb 28, 2023Nationwide• Bio-Rad Laboratories, Inc.

Butter Toffee (Bruttles) - undeclared milk/soy (2023)

The Butter Toffee, 16oz box, declares butter but does not declare milk. Label does not declare soy which is present in the non-stick spray being used on the Butter Toffee production trays. The Butter Toffee, 4oz part of the SAMPLERS package, declares butter but does not declare milk, and it does not declare soy which is present in the non-stick spray being used on the Butter Toffee production trays.

Class IIModerate

FDAFeb 28, 2023IN, WA• 4 J's Treats, LLC dba Bruttles Gourmet Candies

BODYARMOR SportWater - potential plastic contamination (2023)

Potential for plastic pieces in product

Class IIModerate

FDAFeb 28, 2023AL, AR, IL +8 more• BA Sports Nutrition, LLC

Artificial Eye Ointment (Global Pharma) – Bacterial Contamination (2023)

Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria.

Class IHigh

FDAFeb 24, 2023Nationwide• Global Pharma Healthcare Private Limited

Tempus Pro Patient Monitor (Remote Diagnostic) - Safety Issues (2023)

During internal testing, Regulatory Compliance issues were identified regarding the Monitor and Power Supplies for fluid ingress and basic safety issues.

FDAFeb 23, 2023Nationwide• Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom

Automated Peritoneal Dialysis System (Baxter) - Safety Testing (2023)

The electrical safety testing was not properly performed on the impacted devices and additional testing is required

FDAFeb 22, 2023AL, AZ, AR +7 more• Baxter Healthcare Corporation

Egg Roll Wrappers (Baily International) – Peanut contamination (2023)

Peanut contamination (in sub ingredient)

Class IIILow

FDAFeb 22, 2023CO, FL, GA +17 more• Baily International Foods

Wonton Wrappers (Baily International) – Peanut contamination (2023)

Peanut contamination (in sub ingredient)

Class IIILow

FDAFeb 22, 2023CO, FL, GA +17 more• Baily International Foods

Canton Dry Noodle (Baily Foods) – Peanut Contamination (2023)

Peanut contamination (in sub ingredient)

Class IIILow

FDAFeb 22, 2023CO, FL, GA +17 more• Baily International Foods

BioPlex 2200 Calibrator Set (Bio-Rad) - Result Discrepancy (2023)

Bio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while performing lot-to-lot validation against previous lots. Internal testing at Bio-Rad has demonstrated that Lot No. 301481 exhibits a specificity of 94.5% (95% CI 91.8 96.4) whereas the IFU indicates a specificity of 97.8% (95% CI 96.1 98.8%). The reduction in specificity may lead to an increase in the number of false positivesBio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while performing lot-to-lot validation against previous lots. Internal testing at Bio-Rad has demonstrated that Lot No. 301481 exhibits a specificity of 94.5% (95% CI 91.8 96.4) whereas the IFU indicates a specificity of 97.8% (95% CI 96.1 98.8%). The reduction in specificity may lead to an increase in the number of false positivesBio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while performing lot-to-lot validation against previous lots. Internal testing at Bio-Rad has demonstrated that Lot No. 301481 exhibits a specificity of 94.5% (95% CI 91.8 96.4) whereas the IFU indicates a specificity of 97.8% (95% CI 96.1 98.8%). The reduction in specificity may lead to an increase in the number of false positives.There is no performance issue with the calibrator lot# 53727. They are included in the recall only because the calibrators are lot matched to the impacted reagent pack.

FDAFeb 21, 2023Nationwide• Bio-Rad Laboratories, Inc.

BioPlex 2200 Reagent Pack (Bio-Rad) - Result Discrepancy (2023)

FDAFeb 21, 2023Nationwide• Bio-Rad Laboratories, Inc.

Phenylephrine HCl Syringe (Denver Solutions) – manufacturing deviation (2023)

CGMP DEVIATIONS

Class IIModerate

FDAFeb 21, 2023Nationwide• Denver Solutions, LLC DBA Leiters Health