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BioFire Diagnostics, LLC

BioFire Diagnostics, LLC Recalls

All product recalls associated with BioFire Diagnostics, LLC.

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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 161–180 of 21319 recalls

BioFire Respiratory Panel 2.1 (BioFire) – False Negative Risk (2025)

Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.

Moderate

FDAOct 22, 2025Nationwide• BioFire Diagnostics, LLC

CareLink Clinic (Medtronic) – Graph Data Inaccuracy (2025)

Software error causing incorrect data to be displayed on the 24-hour Sensor Glucose Overview Graph, any potential therapy decisions were made based on the incorrect data displayed on the 24-hour sensor glucose overview graph may lead to hypoglycemia or hyperglycemia.

Moderate

FDAOct 21, 2025Nationwide• Medtronic MiniMed, Inc.

VerifyNow PRUTest (Accriva) – Unauthorized Device Distribution (2025)

Due to an device without a premarket clearance being incorrectly package and distributed.

Moderate

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FDA

Oct 21, 2025

Nationwide

• Accriva Diagnostics, Inc.

Sevoflurane V90 Vaporizer (Mindray) – Anesthesia Leakage Risk (2025)

Potential for anesthesia leakage.

Moderate

FDAOct 20, 2025Nationwide• Mindray DS USA, Inc. dba Mindray North America

NIACIN Extended-Release Tablets (Golden State) – Dissolution Failure (2025)

Failed Dissolution Specifications

Class IIModerate

FDAOct 20, 2025Nationwide• Golden State Medical Supply Inc.

HR-ACT Cartridges (Medtronic) – External Label Contamination (2025)

Medtronic personnel observed trace amounts of dry blood on the external carton label and Instructions for Use (IFU) in five boxes of one lot of ACT Cartridges.

Low

FDAOct 20, 2025Nationwide• Medtronic Perfusion Systems

Isoflurane V90 Vaporizer (Mindray) – Anesthesia Leakage Risk (2025)

Potential for anesthesia leakage.

Moderate

FDAOct 20, 2025Nationwide• Mindray DS USA, Inc. dba Mindray North America

IntelePACS (Intelerad) – Software Communication Bug (2025)

Software application that receives digital images and data to be communicated, processed, manipulated, enhanced, stored, displayed has a bug that could cause data loss in Relevant Clinical Info field when modifying studies through Case Editor in either Technologist Portal or Referring Physician Portal, which could result in loss of clinical information, which could impact clinical decision-making.

Moderate

FDAOct 17, 2025Nationwide• INTELERAD MEDICAL SYSTEMS INCORPORATED 800, Boul. de Maisonneuve Est 12th floor Montreal Canada

MAHURKAR Catheter Tray (Mozarc) – Packaging Seal Integrity (2025)

A potential issue with the seal integrity of header bag packaging.

Low

FDAOct 17, 2025Nationwide• Mozarc Medical US LLC

EZDilate Nephrostomy Catheter (Olympus) – Incorrect Balloon Size (2025)

Device kits contained an incorrectly sized 4mm x 4cm urinary tract balloon catheter (BURS0404) instead of the correct 8mm x 15cm nephrostomy tract balloon catheter (BPCN0815). All other components in the kits were correctly included and packaged in the kit.

Moderate

FDAOct 17, 2025AK, CA, IA +3 more• Olympus Corporation of the Americas

Prazosin Hydrochloride 2mg Capsules (Amerisource) – Impurity Risk (2025)

Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit

Class IIModerate

FDAOct 16, 2025Nationwide• Amerisource Health Services LLC

VANTAGE GALAN 3T (Canon Medical) – Electrode Distance Compliance (2025)

Affected system contains components that do not meet the required distance between electrodes for compliance with the IEC 60601-1 standard for medical electrical equipment.

Moderate

FDAOct 16, 2025NV, OH• Canon Medical System, USA, INC.

Ceiling Type X-Ray Tube Support (Shimadzu) – Mounting Shaft Risk (2025)

Due to an issue (potential breakage) with the shaft for the mounting of the X-ray tube assembly that could potentially result assembly coming off the rotating shaft.

High

FDAOct 16, 2025Nationwide• SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Nishinokyo Kuwabara Cho Nakagyo-Ku

Prazosin Hydrochloride 5mg Capsules (Amerisource) – Impurity Risk (2025)

Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit

Class IIModerate

FDAOct 16, 2025Nationwide• Amerisource Health Services LLC

Prazosin Hydrochloride 1mg Capsules (Amerisource) – Impurity Risk (2025)

Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit

Class IIModerate

FDAOct 16, 2025Nationwide• Amerisource Health Services LLC

IC Bus CESB (IC Bus) – Transmission Actuator Fault (2025)

International Motors, LLC (International) is recalling certain 2026 IC Bus CESB school buses. The transmission shift actuator may not have been calibrated properly, preventing the transmission from shifting into reverse.

High

NHTSAOct 15, 2025Nationwide• IC BUS

EVIS EXERA III Duodenovideoscope (Olympus) – Reprocessing Update (2025)

Continued reports of positive cultures and infections have identified updates to the reprocessing materials to minimize potential deviations in TJF duodenoscope reprocessing. Olympus is informing users of these changes, reminding users to closely follow the operation and reprocessing instructions, and providing updated materials to users.

Moderate

FDAOct 14, 2025Nationwide• Olympus Corporation of the Americas