Class IIOngoingZ-1697-2026
Intuitive Surgical, Inc. recalls Brand Name: da Vinci S
Due to increased complaints for broken/frayed grip cables for reusable instruments.
Intuitive Surgical, In…CAApr 8, 2026
Recalls: Process control
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 169–180 of 816 recalls
Class IIOngoingZ-1696-2026
Intuitive Surgical, Inc. recalls Brand Name: da Vinci S
Due to increased complaints for broken/frayed grip cables for reusable instruments.
Intuitive Surgical, In…CAApr 8, 2026
Class IIOngoingZ-1695-2026
Olympus Corporation Of The Americas recalls Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE Pro Las…
Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable.…
Olympus Corporation of…PAApr 8, 2026
Class IIOngoingZ-1694-2026
Olympus Corporation Of The Americas recalls Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Pre…
Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable.…
Olympus Corporation of…PAApr 8, 2026
Class IIOngoingZ-1689-2026
Ultradent Products, Inc. recalls Jiffy Original Composite Polisher Cups (Coarse) 12pk
Composite polisher cups may crumble and break apart easily, which could cause a delay in patient treatment.
Ultradent Products, In…UTApr 8, 2026
Class IIOngoingZ-1657-2026
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Enzymatic Hemoglobin A1c (A1c_E)
A potential for depressed results for Atellica CH A1c_E when processing Atellica CH RCRP on the same analyzer. Customers processing A1c_E and RCRP on separate analyzers are not impacted by the recall.…
Siemens Healthcare Dia…NYApr 8, 2026
Class IOngoingZ-1637-2026
Baxter Healthcare Corporation recalls Blue Ventilator Adapter Module
Urgent Medical Device Correction for the Volara system single-patient use circuit due to the potential that patients or caregivers may be unaware of a possible decrease in oxygen levels (oxygen desaturation), or potentia…
Baxter Healthcare Corp…ILApr 8, 2026
Class IIOngoingZ-1634-2026
AMO Puerto Rico Manufacturing, Inc. recalls Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: T…
Due to identifying a limited quantity of intraocular lenses that may have a haptic that sticks to the optic which prevents the lens from unfolding as consistently as expected.
AMO Puerto Rico Manufa…PRApr 1, 2026
Class IIOngoingZ-1633-2026
Straumann USA LLC recalls Custom Abutment AS Ti
A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly identified as a Titanium Bar Ti Gr…
Straumann USA LLCMAApr 1, 2026
Class IIOngoingZ-1632-2026
Straumann USA LLC recalls Custom Abutment Ti
A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly identified as a Titanium Bar Ti Gr…
Straumann USA LLCMAApr 1, 2026
Class IOngoingZ-1579-2026
Merit Medical Systems, Inc. recalls BioFlo DuraMax Catheter
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss o…
Merit Medical Systems,…UTApr 1, 2026
Class IOngoingZ-1578-2026
Merit Medical Systems, Inc. recalls DuraMax Chronic Hemodialysis Catheter
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss o…
Merit Medical Systems,…UTApr 1, 2026