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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 5121–5140 of 21320 recalls

Da Vinci S/Si Large Clip Applier (Intuitive Surgical) – Unexpected Motion Risk (2022)

Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system.

Moderate

FDAJul 1, 2022Nationwide• Intuitive Surgical, Inc.

Lidocaine Cream (Mohnark) – child-resistant packaging (2022)

The recall involves Mohnark Pharmaceuticals Lidocaine 4% Topical Anesthetic Cream. The product was sold in a white tube with a flip-top closure. Mohnark Pharmaceuticals is printed under the blue and green logo on the right side of the product tube. The lot code is located at the bottom of the product tube. The affected lot codes are 01202201, 210201, 210301, 210503, 210505, 210601, 211002 and 210401. The UPC 860002324906 is located on bottom side panel of the packaging.

Low

CPSCJun 30, 2022Nationwide• Mohnark Pharmaceuticals Inc., of Davie, Fla.

Echelon -14 Micro Catheter (Micro Therapeutics) – Packaging Water Damage (2022)

Outer carton packaging of microcatheters were exposed to wet substance during transport.

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Moderate

FDAJun 30, 2022Nationwide• Micro Therapeutics, Inc.

2020 BUICK REGAL (BUICK) – Brake Assist Software Error (2022)

General Motors, LLC (GM) is recalling certain 2018-2020 Buick Regal vehicles. In the event of a vacuum-power brake assist failure, a software error in the electronic brake control module (EBCM) may result in a loss of power brake assist. As such, these vehicles fail to conform to Federal Motor Vehicle Safety Standard No. 135, "Light vehicle brake systems."

High

NHTSAJun 30, 2022Nationwide• BUICK

Echelon -14, 45 Tip Shape (Micro Therapeutics) – Packaging Water Damage (2022)

Outer carton packaging of microcatheters were exposed to wet substance during transport.

Low

FDAJun 30, 2022Nationwide• Micro Therapeutics, Inc.

Orthex External Fixation Wire (OrthoPediatrics) – Wire Tip Fracture Risk (2022)

Manufacturing variance near transition of tip is increasing the likelihood the wire tip may fracture. The fractured tip may be retained in the patient. Retrieval attempts may be made which could result in a delay of surgery and potentially damage soft tissue and increase healing time

High

FDAJun 29, 2022Nationwide• OrthoPediatrics Corp

ATTUNE Measured Sizing Guide (DePuy Orthopaedics) – Incorrect Spring Material (2022)

Manufactured with a Galvanized High Carbon Steel spring instead of the correct 302 Stainless steel spring. has the potential to oxidize and corrode in the ATTUNE Measured Sizing & Rotation Guide, resulting in surgical delay, debris in surgical field, Osteolysis, Poor Joint Mechanics, Soft Tissue Irritation, Pain

Moderate

FDAJun 29, 2022Nationwide• DePuy Orthopaedics, Inc.

GenTeal Tears Night-Time Eye Ointment (Mckesson) – Storage Deviation (2022)

CGMP Deviations: products were stored outside the drug label specifications.

Class IIModerate

FDAJun 29, 2022Nationwide• Mckesson Medical-Surgical Inc. Corporate Office

Systane Balance Eye Drops (Mckesson) – Storage Deviation (2022)

CGMP Deviations: products were stored outside the drug label specifications.

Class IIModerate

FDAJun 29, 2022Nationwide• Mckesson Medical-Surgical Inc. Corporate Office

Systane Zaditor Ketotifen Eye Drops (Mckesson) – Storage Deviation (2022)

CGMP Deviations: products were stored outside the drug label specifications.

Class IIModerate

FDAJun 29, 2022Nationwide• Mckesson Medical-Surgical Inc. Corporate Office

Racepinephrine Inhalation Solution (Mckesson) – Storage Deviation (2022)

CGMP Deviations: products were stored outside the drug label specifications.

Class IIModerate

FDAJun 29, 2022Nationwide• Mckesson Medical-Surgical Inc. Corporate Office

Triple Antibiotic Ointment (Mckesson) – Storage Deviation (2022)

CGMP Deviations: products were stored outside the drug label specifications.

Class IIModerate

FDAJun 29, 2022Nationwide• Mckesson Medical-Surgical Inc. Corporate Office

Asthmanefrin Racephinephrine Inhalation Solution (Mckesson) – Storage Deviation (2022)

CGMP Deviations: products were stored outside the drug label specifications.

Class IIModerate

FDAJun 29, 2022Nationwide• Mckesson Medical-Surgical Inc. Corporate Office

Dakin's Solution 0.125% Sodium Hypochlorite (Mckesson) – Storage Deviation (2022)

CGMP Deviations: products were stored outside the drug label specifications.

Class IIModerate

FDAJun 29, 2022Nationwide• Mckesson Medical-Surgical Inc. Corporate Office

Testosterone Gel 1% (Teva) – Superpotent Drug Issue (2022)

Superpotent Drug: Out of specification assay result was obtained during stability testing.

Class IIModerate

FDAJun 29, 2022Nationwide• Teva Pharmaceuticals USA Inc

Telmisartan Hydrochlorothiazide Tablets (Glenmark) – Packaging Issue (2022)

Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .

Class IIModerate

FDAJun 29, 2022Nationwide• Glenmark Pharmaceuticals Inc., USA

Naphcon A Eye Drops (Mckesson) – Storage Deviation (2022)

CGMP Deviations: products were stored outside the drug label specifications.

Class IIModerate

FDAJun 29, 2022Nationwide• Mckesson Medical-Surgical Inc. Corporate Office

Desmopressin Acetate Tablets (Glenmark) – Manufacturing Deviation (2022)

CGMP Deviations

Class IIModerate

FDAJun 29, 2022IN, TX• Glenmark Pharmaceuticals Inc., USA

Debrox Earwax Removal Aid (Mckesson) – Storage Deviation (2022)

CGMP Deviations: products were stored outside the drug label specifications.

Class IIModerate

FDAJun 29, 2022Nationwide• Mckesson Medical-Surgical Inc. Corporate Office

Telmisartan Hydrochlorothiazide Tablets (Glenmark) – Packaging Issue (2022)

Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .

Class IIModerate

FDAJun 29, 2022Nationwide• Glenmark Pharmaceuticals Inc., USA