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Staar Surgical Company

Staar Surgical Company Recalls

All product recalls associated with Staar Surgical Company.

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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 3301–3320 of 21320 recalls

EVO+VISIAN Lens (Staar Surgical) – Specification Concerns (2023)

Their is a potential that intraocular implant devices may not meet specifications.

Moderate

FDASep 29, 2023AZ, AR, CA +35 more• Staar Surgical Company

ION*Sinus Spray (Biomic Sciences) – microbial contamination (2023)

Microbial contamination of Non-Sterile Products

Class IHigh

FDASep 29, 2023Nationwide• Biomic Sciences, LLC dba ION Intelligence of Nature

ION* Sinus Support Nasal Spray (Biomic Sciences) – microbial contamination (2023)

Microbial contamination of Non-Sterile Products

Class IIModerate

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Page 166 of 1066Next

FDA

Sep 29, 2023

Nationwide

• Biomic Sciences, LLC dba ION Intelligence of Nature

Atrium Thoracic Catheter (Atrium) – Expiration Date Error (2023)

A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled expiration date.

Moderate

FDASep 29, 2023AL, AZ, CA +11 more• Atrium Medical Corporation

Restore Sinus Spray (Biomic Sciences) – microbial contamination (2023)

Microbial contamination of Non-Sterile Products

Class IIModerate

FDASep 29, 2023Nationwide• Biomic Sciences, LLC dba ION Intelligence of Nature

Liposomal Multivitamins (Solaray) – Packaging concern (2023)

This recall involves Solaray Liposomal Women's in 60 and 120 count, Solaray Universal Multivitamin in 60 and 120 count, and Solaray Liposomal Women's 50+ Multivitamin in 120 count. The bottles are a clear silver color with white pop top lids. The white label on the front of the bottles displays the Solaray logo, product name, product type and size count. The 60 count bottles are contained in cartons, which are substantially similar in appearance to the bottles inside. All lots are included in the recall. Name Count SKU Solaray Liposomal Women's 60 076280193251 Solaray Liposomal Women's 120 076280339536 Solaray Universal Multivitamin 60 076280640168 Solaray Universal Multivitamin 120 076280830385 Solaray Liposomal Women's 50+ Multivitamin 120 076280154832

High

CPSCSep 28, 2023Nationwide• Nutraceutical Corporation, of Salt Lake City, Utah

Tracheal Intubation Fiberscope (Olympus) – Flow Rate Issue (2023)

Fiberscopes do not have adequate data to support that the suction flow rate meets the device specification.

Moderate

FDASep 28, 2023Nationwide• Olympus Corporation of the Americas

StealthStation S8 (Medtronic) – Surgical Data Shift (2023)

Due to a software anomaly which potentially could result in the surgical planning data shifting to an unintended location.

High

FDASep 27, 2023Nationwide• Medtronic Navigation, Inc.

EXALT Duodenoscope (Boston Scientific) – Image Quality Problem (2023)

Poor image quality due to fluid ingress in the lens.

Moderate

FDASep 27, 2023Nationwide• Boston Scientific Corporation

Micro Spike Adapter (B. Braun) – Potential Leakage Risk (2023)

Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-threatening situations to occur requiring additional medical intervention.

High

FDASep 26, 2023Nationwide• B. Braun Medical, Inc.

TheraSphere Admin Set (B. Braun) – Potential Leakage Risk (2023)

High

FDASep 26, 2023Nationwide• B. Braun Medical, Inc.

Grafton Plus DBM Paste (Medtronic) – Packaging Inspection Issue (2023)

Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.

Moderate

FDASep 26, 2023Nationwide• Medtronic Sofamor Danek USA Inc

RapidPoint 500e System (Siemens) – Drug Interference Risk (2023)

There are potential drug interferences from Perhexiline Maleate or Atomoxetine Hydrochloride that may cause falsely elevated sodium results reported on the RAPIDPoint 500 and RAPIDPoint 500e Blood Gas Systems. The erroneous sodium levels with positive bias may lead to unrecognized hyponatremia and/or the inappropriate treatment of hypernatremia may lead to iatrogenic hyponatremia, resulted in a delay in patient diagnosis and optimal patient management.

High

FDASep 26, 2023Nationwide• Siemens Healthcare Diagnostics Inc