Medical Device Recalls | FDA Device Safety Alerts And Recall Notices

Medical Device Recall Alerts List

Showing 401 - 425 of 1,678 matching product recalls.

Product Recall	Source	Type	Risk	Date	Action
Digital Angiography System Trinias:UD150G-40 / D150GC-40; Digital Angiography System BRANSIST safire:UD150G-40 / D150GC-40; Digital Angiography System BRANSIST alexa:UD150G-40 / D150GC-40; Digital Radiography System RADspeed Pro: UD150B-40 / UD150V-40 / UD150L-40 / UD150L-40E/D150BC-40 / D150VC-40 / D150LC-40 / D150LC-40E/D150BC-41 / D150VC-41 / D150LC-41; Digital Radiography System RADspeed safire: UD150B-40 / D150BC-40; Radiography System RADspeed fit: N/A (Integrated in the system); X-RAY R/F SYSTEM SONIALVISION safire17:UD150B-40 / D150BC-40; X-RAY R/F SYSTEM SONIALVISION safire Plus: UD15 Electromagnetic contactors within high voltage generator may weld together, resulting in current being supplied to power supply even if power is off.	FDA Z-2294-2026	Medical Device	High	Jun 10, 2026 Recall: Apr 20, 2026	Details
BD Pyxis Anesthesia Station ES REF: 327 Medication cabinet Fingerprint scanner may overheat to a temperature to cause 1st degree burn.	FDA Z-2299-2026	Medical Device	High	Jun 10, 2026 Recall: Apr 30, 2026	Details
The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004. Potential for the Cassette Loading Lever to break.	FDA Z-2274-2026	Medical Device	High	Jun 10, 2026 Recall: Feb 4, 2026	Details
BD¿Spinal Tray with BD¿Quincke Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405609. This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.	FDA Z-2248-2026	Medical Device	High	Jun 10, 2026 Recall: Apr 27, 2026	Details
ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.	FDA Z-2205-2026	Medical Device	High	Jun 10, 2026 Recall: Mar 9, 2026	Details
BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 2 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405658. This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.	FDA Z-2254-2026	Medical Device	High	Jun 10, 2026 Recall: Apr 27, 2026	Details
BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in., BD¿Quincke Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405741. This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.	FDA Z-2253-2026	Medical Device	High	Jun 10, 2026 Recall: Apr 27, 2026	Details
Spinal Needle procedure kits: Material Description (Material Number) 24GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333867); 25GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333862); GOVP24BK 24G PENCAN TRAY W/ BUP & DEXTROS (332607); P24BK 24G PENCAN TRAY W/BUP & DEXTROSE (333868); P25BKAY PENCAN SPINAL TRAY (333865); P27BK PENCAN SPINAL W/BUPIVAC (333871); P25BK SPINAL TRAY (333851) These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huon Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspection.	FDA Z-2276-2026	Medical Device	High	Jun 10, 2026 Recall: May 6, 2026	Details
PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050 The recall is being conducted due to corrosion of the internal metallic spring within the sprayer component. This condition is caused by material incompatibility between the product solution and the stainless steel spring and may result in visible discoloration and the presence of trace levels of metallic elements (including iron, chromium, and nickel) in the solution during use.	FDA Z-2275-2026	Medical Device	High	Jun 10, 2026 Recall: Apr 27, 2026	Details
BD¿Spinal Tray with BD¿Quincke Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 405621, 405735. This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.	FDA Z-2249-2026	Medical Device	High	Jun 10, 2026 Recall: Apr 27, 2026	Details
BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 400866, 405672, 405673, 405674, 405675, 405709, 405721, 405723, 406704. This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.	FDA Z-2255-2026	Medical Device	High	Jun 10, 2026 Recall: Apr 27, 2026	Details
TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis Due to incorrect functional length on device labeling.	FDA Z-2308-2026	Medical Device	High	Jun 10, 2026 Recall: Apr 3, 2026	Details
Philips Azurion 7M20, Model Numbers: 722079, 722224 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.	FDA Z-2291-2026	Medical Device	High	Jun 10, 2026 Recall: Dec 7, 2023	Details
ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS icono floor Model 11327700. interventional fluoroscopic x-ray system During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.	FDA Z-2206-2026	Medical Device	High	Jun 10, 2026 Recall: Mar 9, 2026	Details
Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.	FDA Z-2287-2026	Medical Device	High	Jun 10, 2026 Recall: Dec 7, 2023	Details
Brand Name: B. BRAUN MEDICAL INC. Product Name: BPSK, BLOCKJOCKS TRAY Model/Catalog Number: 570246 Software Version: N/A Product Description: BPSK, BLOCKJOCKS TRAY Component: No B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.	FDA Z-2264-2026	Medical Device	High	Jun 10, 2026 Recall: Jan 29, 2026	Details
BD Pyxis MedStation ES REF: 323 Medication cabinet Fingerprint scanner may overheat to a temperature to cause 1st degree burn.	FDA Z-2298-2026	Medical Device	High	Jun 10, 2026 Recall: Apr 30, 2026	Details
Philips Azurion 7M12, Model Numbers: 722078, 722223 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.	FDA Z-2290-2026	Medical Device	High	Jun 10, 2026 Recall: Dec 7, 2023	Details
COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are intended for use in providing tracheal access for airway management. Shiley Tracheostomy Tubes are double cannula tracheostomy tubes with reusable inner cannulae (LPC, FEN, CFS, CFN, LGT) and twist-lock connectors. These Shiley Tracheostomy Tubes have a radiopaque, biocompatible outer cannula constructed of polyvinyl chloride. Due to customer complaint regarding incorrect display box labeling.	FDA Z-2261-2026	Medical Device	High	Jun 10, 2026 Recall: Apr 15, 2026	Details
Brand Name: B. BRAUN MEDICAL INC. Product Name: NES1725KFXL SPINAL EPID CLOSED TIP CATH Model/Catalog Number: 530201 Software Version: N/A Product Description: NES1725KFXL SPINAL EPID CLOSED TIP CATH Component: No B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.	FDA Z-2265-2026	Medical Device	High	Jun 10, 2026 Recall: Jan 29, 2026	Details
Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus Mid Scala Model/Catalog Number: CI-1601-04 Software Version: N/A Product Description: The HiResolution Bionic Ear System is a cochlear implant designed to provide useful hearing to individuals with severe-to-profound hearing loss. It consists of internal and external components. The internal components include the HiRes" Ultra 3D receiver and either the HiFocus" SlimJ electrode or the HiFocus" Mid-Scala (MS) electrode array that are implanted surgically under the skin behind the ear. The external components inc Due to incorrect shelf-life expiration date.	FDA Z-2283-2026	Medical Device	High	Jun 10, 2026 Recall: Apr 30, 2026	Details
BD Pyxis Anesthesia Station 4000 REF: 338 Medication cabinet Fingerprint scanner may overheat to a temperature to cause 1st degree burn.	FDA Z-2300-2026	Medical Device	High	Jun 10, 2026 Recall: Apr 30, 2026	Details
Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK SHANDS JACKSONVILLE 20055717 Model/Catalog Number: 555884 Software Version: N/A Product Description: CESK SHANDS JACKSONVILLE 20055717 Component: No B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.	FDA Z-2269-2026	Medical Device	High	Jun 10, 2026 Recall: Jan 29, 2026	Details
MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph Software in development inadvertently made available for customer use. Use of this software version can result in clinical information being associated with the incorrect patient. This could impact clinical decision-making.	FDA Z-2306-2026	Medical Device	High	Jun 10, 2026 Recall: Apr 21, 2026	Details
Philips Azurion 7B12/12, Model Numbers: 722067, 722225 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.	FDA Z-2288-2026	Medical Device	High	Jun 10, 2026 Recall: Dec 7, 2023	Details

Showing 401 - 425 of 1,678 product recalls

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Medical Device Recalls Today

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How To Check Medical Device Recalls: FDA Device Safety Alerts And Recall Notices

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Use the linked official notice for final instructions such as repair, replacement, refund, disposal, software update, stop-use or company contact.