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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)

145

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 2201–2220 of 37661 recalls

8MM Tip-Up Fenestrated Grasper (Intuitive Surgical) – Grip Cable Failure (2024)

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

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

8MM Mega Needle Driver (Intuitive Surgical) – Grip Cable Failure (2024)

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

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

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

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

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

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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.

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

KARL STORZ Uretero-Renoscope (Karl Storz) – Reprocessing Modality Issue (2024)

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

FDADec 19, 2024Nationwide• Karl Storz Endoscopy

KARL STORZ Pediatric Uretero-Renoscope (Karl Storz) – Reprocessing Issue (2024)

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

FDADec 19, 2024Nationwide• Karl Storz Endoscopy

KARL STORZ Uretero-Renoscope (Karl Storz) – Reprocessing Modality Issue (2024)

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

FDADec 19, 2024Nationwide• Karl Storz Endoscopy

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.

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

Stryker Blueprint Mixed Reality Pin Guide (Tornier) – Device Disassembly Risk (2024)

The Pin Guide is being recalled because the metal tube may disassemble from the plastic handle. This can result in the Blueprint Mixed Reality headset being unable to detect the Pin Guide and potentially prolonging surgery time or changing of surgical method from guided to conventional.

FDADec 18, 2024AK, ID, KY +4 more• Tornier S.A.S. 161 Rue Lavoisier Montbonnot-Saint-Martin France

GE Healthcare Infinia I (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.

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)

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.

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)

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.

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)

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.

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

Alpha Test (Iovate) - Cathine Presence (2024)

Presence of cathine in product

Class IIModerate

FDADec 18, 2024AZ, CA, CO +27 more• Iovate Health Sciences USA Inc.

HemosIL Heparin Calibrators (Instrumentation Laboratory) – Quality Control Problem (2024)

Control indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range.

FDADec 18, 2024Nationwide• Instrumentation Laboratory

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.

FDADec 18, 2024Nationwide• Olympus Corporation of the Americas

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

Failed Dissolution Specifications:

Class IIModerate

FDADec 17, 2024Nationwide• Amerisource Health Services LLC

Tesla Model 3 (Tesla) – Tire Pressure Monitor Malfunction (2024)

Tesla, Inc. (Tesla) is recalling certain 2024 Cybertruck, 2017-2025 Model 3, and 2020-2025 Model Y vehicles. The tire pressure monitoring system (TPMS) warning light may not remain illuminated between drive cycles, failing to warn the driver of low tire pressure. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 138, "Tire Pressure Monitoring Systems."

NHTSADec 17, 2024Nationwide• TESLA

CODMAN CERTAS Plus Valve (Integra) – Incorrect Product Labels (2024)

Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.

FDADec 16, 2024Nationwide• Integra LifeSciences Corp.