Class IIOngoingZ-2403-2026
Boston Scientific Neuromodulation Corporation recalls Boston Scientific TCN Electrodes: REF: TCN-5
Reusable electrodes may not meet expected performance levels.
Boston Scientific Neur…CAJun 17, 2026
Class II recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 241–252 of 3,846 recalls
Class IIOngoingZ-2402-2026
Boston Scientific Neuromodulation Corporation recalls Boston Scientific CSK Electrodes: REF: CSK-TC10
Reusable electrodes may not meet expected performance levels.
Boston Scientific Neur…CAJun 17, 2026
Class IIOngoingZ-2401-2026
Fresenius Medical Care Holdings, Inc. recalls Bicarby Dialysate
There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and printed labeling on the product correctly identifies the product code and the solution contained in…
Fresenius Medical Care…MAJun 17, 2026
Class IIOngoingZ-2400-2026
Inter-Med LLC recalls Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit
Some units of Aluminum Chloride Gel contain the package insert for Ferric Sulfate Gel. The incorrect insert misidentifies the product and contains different first aid instructions, most critically in that the Ferric Sulf…
Inter-Med LlcWIJun 17, 2026
Class IIOngoingZ-2399-2026
DT MedTech, LLC recalls Hintermann Series Talar Implant
Through customer complaints, the ankle replacement system was found to contain incorrect devices: Left implant packaging and labeling bears a right implant device.
DT MedTech, LLCTNJun 17, 2026
Class IIOngoingZ-2398-2026
Siemens Healthcare Diagnostics, Inc. recalls Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC)
A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge.
Siemens Healthcare Dia…DEJun 17, 2026
Class IIOngoingZ-2362-2026
The Binding Site Group, Ltd. recalls Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A…
It was reported that plates 2 and 3 were marked as passed , although it appeared that QC had not been performed on these plates, despite samples being measured.…
The Binding Site Group…Jun 17, 2026
Class IIOngoingZ-2361-2026
Medartis AG recalls Medartis APTUS
The cannulation of the CCS screw is not centered.
Medartis AGJun 17, 2026
Class IIOngoingZ-2356-2026
Sagemax Bioceramics, Inc. recalls NexxZr T Multi A3.5 W98-16mm
Yttrium-stabilized zirconium oxide discs for fixed all-ceramic dental restorations may have reduced or missing dentin layer and when used clinically in the patient's mouth there is an increased risk of fractures under f…
Sagemax Bioceramics, I…WAJun 17, 2026
Class IIOngoingZ-2355-2026
In2bones USA, LLC recalls NeoSpan¿ SuperElastic Compression Staple w/Instruments Catalog Number and Product Nam…
Due to the Magnetic Resonance Conditional Symbol missing on the carton, inner tray, and patient label.
In2bones USA, LLCTNJun 17, 2026
Class IIOngoingZ-2354-2026
Philips North America LLC recalls DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035.
System was delivered without the required Seismic kit for Wall Stand VS2, which is designed to prevent damage and ensure stability of the Wall Stand VS2 during seismic events.
Philips North America…MAJun 17, 2026
Class IIOngoingZ-2353-2026
Micromed S.P.A. recalls SD LTM 64 PLUS
Natus has become aware of two complaints related to the SD LTM 64 PLUS where the EEG traces acquired from two or four different amplifiers used in a multiple amplifier configuration (128 or 256 channels) running firmware…
Micromed S.p.A.Jun 17, 2026