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Fisher Diagnostics

Fisher Diagnostics Recalls

All product recalls associated with Fisher Diagnostics.

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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 1101–1120 of 21319 recalls

Pacific Hemostasis Thromboplastin-D (Fisher Diagnostics) – Incorrect ISI Label (2025)

The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.

Low

FDAMar 6, 2025PA• Fisher Diagnostics

Venue Fit Models R3/R4 (GE Medical Systems) – Battery Fire Risk (2025)

Fire/Burn Risk

The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.

High

FDAMar 6, 2025Nationwide• GE Medical Systems, LLC

HiResolution Bionic Ear Battery Charger (Advanced Bionics) – Incorrect Packaging (2025)

Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified.

Low

FDA

1...54 555657 58...1066

Page 56 of 1066Next

Mar 5, 2025

AZ, FL, MI +3 more

• Advanced Bionics, LLC

Prasugrel Tablets (Golden State Medical) – Dissolution Failure (2025)

Failed Dissolution Specifications

Class IIModerate

FDAMar 5, 2025Nationwide• Golden State Medical Supply Inc.

ID NOW Influenza A/B Test (Abbott) – High Invalid Rate (2025)

The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.

Moderate

FDAMar 4, 2025Nationwide• Abbott Diagnostics Scarborough, Inc.

ID NOW RSV Test (Abbott) – High Invalid Rate (2025)

The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.

Moderate

FDAMar 4, 2025Nationwide• Abbott Diagnostics Scarborough, Inc.

InPen Smart Insulin Pen (Medtronic) – Assembly Error (2025)

Insulin pens may have been incorrectly assembled therefore users could experience the following: either the insulin cartridge will not fit into the cartridge holder; or the cartridge holder may be difficult to remove from the insulin pen. If the issue is present, and if the user does not have backup insulin they may experience temporary hyperglycemia.

Moderate

FDAMar 4, 2025AL, AZ, AR +38 more• Medtronic MiniMed, Inc.

ID NOW COVID-19 Test (Abbott) – High Invalid Rate (2025)

The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.

Moderate

FDAMar 4, 2025Nationwide• Abbott Diagnostics Scarborough, Inc.

Stimulation RC Programmer (Medtronic) – Software Communication Fault (2025)

There is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific intraoperative programming sequence is used.

Moderate

FDAMar 4, 2025Nationwide• Medtronic Neuromodulation

Gabapentin Capsules (Sun Pharmaceutical) – Cross Contamination (2025)

Cross Contamination

Class IIILow

FDAMar 4, 2025Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Gabapentin Capsules (Sun Pharmaceutical) – Cross Contamination (2025)

Cross Contamination

Class IIILow

FDAMar 4, 2025Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Tolterodine Tartrate (Major Pharmaceuticals) – Dissolution Failure (2025)

Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.

Class IIILow

FDAMar 4, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Comprehensive Shoulder Stem (Zimmer) – Surgical Insertion Problem (2025)

Five complaints received where surgeon was unable to remove and/or connect the inserter with the stem during surgery due to excess material remaining within the taper. Issue may lead to clinically significant extension of surgery to find a replacement.

Moderate

FDAMar 3, 2025Nationwide• ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY Deerpark Industrial Estate Oranmore Ireland

Phoroptor VRx Digital Refraction System (Reichert) – Head Detachment Risk (2025)

The head of the phoropter head could come loose and potentially detach due to a default in the assembly.

Moderate

FDAFeb 28, 2025Nationwide• Reichert, Inc.

Spectral CT on Rails (Philips) – Software Scanning Problems (2025)

Multiple problems identified with the software version leading to various scanning and image issues, and unintended device movement.

Moderate

FDAFeb 28, 2025MN• Philips Medical Systems Nederland B.V. Veenpluis

Duloxetine Capsules 20mg (Breckenridge) – Nitrosamine Impurity (2025)

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.

Class IIModerate

FDAFeb 28, 2025Nationwide• Breckenridge Pharmaceutical, Inc.

Carvedilol Tablets 25mg (Glenmark) – Nitrosamine Risk (2025)

CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit

Class IIModerate

FDAFeb 28, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Duloxetine Capsules 60mg (Breckenridge) – Nitrosamine Impurity (2025)

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.

Class IIModerate

FDAFeb 28, 2025Nationwide• Breckenridge Pharmaceutical, Inc.

Carvedilol Tablets 12.5mg (Glenmark) – Nitrosamine Risk (2025)

CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit

Class IIModerate

FDAFeb 28, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Carvedilol Tablets 3.125mg (Glenmark) – Nitrosamine Risk (2025)

CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit

Class IIModerate

FDAFeb 28, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA