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Intuitive Surgical, Inc.

Intuitive Surgical, Inc. Recalls

All product recalls associated with Intuitive Surgical, 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 1381–1400 of 21319 recalls

8MM Force Bipolar (Intuitive Surgical) – Grip Cable Failure (2024)

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Moderate

FDADec 19, 2024AL, AK, AZ +49 more• Intuitive Surgical, Inc.

8MM Curved Bipolar Dissector (Intuitive Surgical) – Grip Cable Failure (2024)

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Moderate

FDADec 19, 2024AL, AK, AZ +49 more• Intuitive Surgical, Inc.

8MM Small Grasping Retractor (Intuitive Surgical) – Grip Cable Failure (2024)

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Moderate

FDADec 19, 2024AL, AK, AZ +49 more• Intuitive Surgical, Inc.

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GE Healthcare Discovery NM 630 (GE Medical Systems) – Nuclear Medicine System Issue (2024)

GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.

High

FDADec 18, 2024Nationwide• GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel

GE Healthcare Infinia I (GE Medical Systems) – Nuclear Medicine System Issue (2024)

High

FDADec 18, 2024Nationwide• GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel

GE Healthcare Brivo NM 615 (GE Medical Systems) – Nuclear Medicine System Issue (2024)

High

FDADec 18, 2024Nationwide• GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel

GE Healthcare Optima NM/CT 640 (GE Medical Systems) – Nuclear Medicine System Issue (2024)

High

FDADec 18, 2024Nationwide• GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel

GE Healthcare Varicam Millennium (GE Medical Systems) – Nuclear Medicine System Issue (2024)

High

FDADec 18, 2024Nationwide• GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel

Olympus MAJ-891 Forceps/Irrigation Plug (Olympus) – Biomaterial Retention Risk (2024)

Potential for inadvertent retention of biomaterial when the reprocessing procedure is not performed as instructed, so as not completely removing and disassembling the device.

Moderate

FDADec 18, 2024Nationwide• Olympus Corporation of the Americas

Colchicine Capsules 0.6mg (Granules) – dissolution failure (2024)

Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.

Class IIModerate

FDADec 18, 2024Nationwide• Granules Pharmaceuticals Inc.

GlipiZIDE Extended-Release Tablets (Amerisource) – Dissolution Failure (2024)

Failed Dissolution Specifications:

Class IIModerate

FDADec 17, 2024Nationwide• Amerisource Health Services LLC

LithoCrushV Mechanical Lithotriptor (Olympus) – Distal Tip Tearing (2024)

Potential for distal tip tearing of the Mechanical Lithotriptor V.

Moderate

FDADec 16, 2024Nationwide• Olympus Corporation of the Americas

Atropine Sulfate Ophthalmic Solution (Somerset) – Impurity Specifications (2024)

Failed Impurities/Degradation Specifications

Class IIILow

FDADec 16, 2024Nationwide• SOMERSET THERAPEUTICS LLC

Panther Fusion GBS Assay (Hologic) – Pouch Seal Weakness (2024)

Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or incorrect results leading to a possible delay of treatment.

Moderate

FDADec 13, 2024AR, CA, CT +17 more• Hologic, Inc.

Clobazam Tablets (Amerisource) – Foreign Tablet Contamination (2024)

Presence of Foreign Tablets/Capsules

Class IIModerate

FDADec 13, 2024Nationwide• Amerisource Health Services LLC

Horizon Organic Whole Milk (Horizon) - Premature Spoilage (2024)

Potential for premature product spoilage during shelf life.

Class IIModerate

FDADec 13, 2024AZ, CA, IN +1 more• Horizon Organic Dairy, LLC

VALITUDE CRT-P (Boston Scientific) – Safety Mode Potential (2024)

A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.

Moderate

FDADec 12, 2024Nationwide• Boston Scientific Corporation