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AVID Medical, Inc.

AVID Medical, Inc. Recalls

All product recalls associated with AVID Medical, Inc..

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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 761–780 of 21319 recalls

HVI Cardiac Robot Pack (AVID Medical) – Visualization System Error (2025)

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

Low

FDAJun 11, 2025CA, IL, MD +4 more• AVID Medical, Inc.

Robotic Prostatectomy Pack (AVID Medical) – Visualization System Error (2025)

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

Low

FDAJun 11, 2025CA, IL, MD +4 more• AVID Medical, Inc.

VITROS Chemistry Products (Ortho-Clinical Diagnostics) – QC Drift Issue (2025)

Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are used 2-7 days after reconstitution; however, the label stability claims for the PV fluids is 7 days following reconstitution. This may lead to inaccurate QC results. The use of the PVs when the QC results are outside of the customer s established ranges could result in delayed results for patients due to the need to repeat QC testing or reconstitute new PV fluids and repeat testing. It could also result in erroneous patient results (small positive bias).

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Moderate

FDAJun 10, 2025Nationwide• Ortho-Clinical Diagnostics, Inc.

VersaCross Access Solution (Boston Scientific) – Sterile Barrier Compromise (2025)

Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due to small size and variable location.

High

FDAJun 10, 2025Nationwide• Boston Scientific Corporation

VersaCross Transseptal Sheath Kit (Boston Scientific) – Sterile Barrier Compromise (2025)

High

FDAJun 10, 2025Nationwide• Boston Scientific Corporation

Torflex Transseptal Sheath Kit (Boston Scientific) – Sterile Barrier Compromise (2025)

High

FDAJun 10, 2025Nationwide• Boston Scientific Corporation

VersaCross RF Wire (Boston Scientific) – Sterile Barrier Compromise (2025)

High

FDAJun 10, 2025Nationwide• Boston Scientific Corporation

VITROS Chemistry CHE Slides (Ortho-Clinical Diagnostics) – QC Drift Issue (2025)

Moderate

FDAJun 10, 2025Nationwide• Ortho-Clinical Diagnostics, Inc.

MIGHTYLICIOUS Vegan Cookies – undeclared milk (2025)

Undeclared Allergen

Undeclared Milk

Class IHigh

FDAJun 10, 2025IL, NY, RI• Mightylicious Inc.

Akreos Intraocular Lens (Bausch & Lomb) – Diopter Calculation Error (2025)

An off-power error was identified, which resulted in a diopter of 16, rather than the intended 3 diopter. Implantation of affected intraocular lens could result in functional visual impairment or reduction in visual acuity which could result in the need for optical or surgical correction.

High

FDAJun 6, 2025AZ, CA• Bausch & Lomb Surgical, Inc.

Superion IDS Kit (Boston Scientific) – Performance Consistency Issue (2025)

As a result of a comprehensive product performance review it was determine that the device and instruments are not consistently meeting expected performance levels. Issues include breakage of the instruments and implant/device.

High

FDAJun 6, 2025Nationwide• Boston Scientific Neuromodulation Corporation

Custom Manifold Kit (Merit Medical) – Air Trapping Risk (2025)

High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient.

High

FDAJun 5, 2025Nationwide• Merit Medical Systems, Inc.

Apollo Smoke and CO Detectors (Apollo America) – Alert Failure (2025)

Fire/Burn Risk

This recall involves Apollo America Combination Smoke and Carbon Monoxide Detectors with model number 51000-600. The recalled detector was sold in a white color. The front of the recalled detector has the text "Replace by" followed by a date ranging from 2034/June to 2034/October. "Apollo" and the model number 51000-600 are on the back of the detector. Note: If you choose to dispose of the detector's primary/non-rechargeable lithium battery, do not throw the battery in the trash, or in the general recycling stream (e.g., street-level or curbside recycling bins). Lithium batteries must be disposed of differently than other batteries, because they present a greater risk of fire. Your municipal household hazardous waste (HHW) collection center or battery recycling boxes found at various retail and home improvement stores may accept this lithium battery for disposal. Before taking your battery to a HHW collection center, contact that office ahead of time and ask whether it accepts lithium batteries. If it does not, contact your municipality for further guidance.

Very High

CPSCJun 5, 2025Nationwide• Apollo America Inc., of Auburn Hills, Michigan

ADVIA Calibrator (Siemens Healthcare) – Platelet Value Error (2025)

Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.

Moderate

FDAJun 4, 2025Nationwide• Siemens Healthcare Diagnostics, Inc.

Azurion 7 M20 X-Ray (Philips Medical) – Gearbox Bolt Loosening (2025)

Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose.

High

FDAJun 4, 2025Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

UROSKOP Omnia (Siemens Medical) – Frequency Inverter Fire Risk (2025)

Fire/Burn Risk

A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire.

High

FDAJun 4, 2025Nationwide• Siemens Medical Solutions USA, Inc

ADVIA 3-in-1 Control (Siemens Healthcare) – Platelet Value Error (2025)

Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.

Moderate

FDAJun 4, 2025Nationwide• Siemens Healthcare Diagnostics, Inc.

Stay Informed

AVID Medical, Inc. Recalls

Recall Summary

HVI Cardiac Robot Pack (AVID Medical) – Visualization System Error (2025)

Robotic Prostatectomy Pack (AVID Medical) – Visualization System Error (2025)

VITROS Chemistry Products (Ortho-Clinical Diagnostics) – QC Drift Issue (2025)

VersaCross Access Solution (Boston Scientific) – Sterile Barrier Compromise (2025)

VersaCross Transseptal Sheath Kit (Boston Scientific) – Sterile Barrier Compromise (2025)

Torflex Transseptal Sheath Kit (Boston Scientific) – Sterile Barrier Compromise (2025)

VersaCross RF Wire (Boston Scientific) – Sterile Barrier Compromise (2025)

VITROS Chemistry CHE Slides (Ortho-Clinical Diagnostics) – QC Drift Issue (2025)

MIGHTYLICIOUS Vegan Cookies – undeclared milk (2025)

Akreos Intraocular Lens (Bausch & Lomb) – Diopter Calculation Error (2025)

Superion IDS Kit (Boston Scientific) – Performance Consistency Issue (2025)

Custom Manifold Kit (Merit Medical) – Air Trapping Risk (2025)

Apollo Smoke and CO Detectors (Apollo America) – Alert Failure (2025)

High Pressure Tubing (Merit Medical) – Air Trapping Risk (2025)

Custom Waste Management Kit (Merit Medical) – Air Trapping Risk (2025)

Custom Tubing Kit (Merit Medical) – Air Trapping Risk (2025)

ADVIA Calibrator (Siemens Healthcare) – Platelet Value Error (2025)

Azurion 7 M20 X-Ray (Philips Medical) – Gearbox Bolt Loosening (2025)

UROSKOP Omnia (Siemens Medical) – Frequency Inverter Fire Risk (2025)

ADVIA 3-in-1 Control (Siemens Healthcare) – Platelet Value Error (2025)