Cardinal Health Presource Kits Recall
Cardinal Health Presource surgical procedure kits containing MEDICOM Ritmed Neurological Sponges have been recalled due to unexpected variability in endotoxin …
Cardinal Health 200, LLC
Medical Device recalls
The newest FDA medical device recalls, in plain English. We list the device, the affected model or lot numbers, the FDA classification, and the corrective action the manufacturer is taking.
138 recalls · updated Jul 14, 2026
Siemens Atellica CH Urine Albumin Recall
Siemens Atellica CH Urine Albumin test kits may produce falsely low results for urea nitrogen and hemoglobin A1c levels, or experience delayed results due to …
Siemens Healthcare Diagnostics, Inc.
Boston Scientific Rapid Refill Injection System Recall
Boston Scientific's Rapid Refill Continuous Injection System contains a recalled syringe component that may loosen or disconnect from the manifold. This can …
Boston Scientific Corporation
Syva Emit Tox Serum Tricyclic Recall
Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2 contains an out-of-specification concentration of sodium azide. Lab technicians may …
Siemens Healthcare Diagnostics, Inc.
Covidien V-Loc 180 Sutures Recall
V-Loc 180 absorbable wound closure sutures (sterile medical devices) may have tears or holes in their sterile packaging, allowing contamination that can cause …
Covidien, LP
Windstone Medical AMS Nerve Block Tray Recall
Windstone Medical Packaging is recalling three AMS Aligned Medical Solutions medical convenience kits because the Lidocaine HCl injection included in them has …
Windstone Medical Packaging, Inc.
Windstone Medical AMS Kits Recall
Windstone Medical Packaging is recalling multiple AMS Aligned Medical Solutions medical convenience kits that contain Lidocaine HCl injection due to supplier …
Windstone Medical Packaging, Inc.
FARASTAR Ablation Generator Recall
Boston Scientific is replacing certain FARASTAR Pulsed Field Ablation generators that cannot work with the FARAPOINT catheter. If your generator has an …
Boston Scientific Corporation
Faradive Steerable Sheath Clear Recall
The Faradive Steerable Sheath Clear used in cardiac catheterization procedures may allow air to enter the bloodstream if the dilator is inserted incorrectly …
Boston Scientific Corporation
ChloraPrep FREPP Applicators Recall
ChloraPrep FREPP sterile skin antiseptic applicators were distributed without proper sterilization, posing a risk of infection. These applicators are used …
CareFusion 213, LLC
OXOS MC2 Portable X-Ray System Recall
The OXOS Medical MC2 Portable X-Ray System is being recalled due to a defective circuit board that can overheat. The device may pose a fire or burn risk to …
Oxos Medical Inc
Orthofix MINIRAIL M101 Recall
Orthofix MINIRAIL external fixation devices were shipped with incorrect model labels. The M101 was labeled as M103, the M103 was labeled as M101, and the M122 …
Orthofix U.S. LLC
Aquacel Ag Surgical SP Recall
ConvaTec is recalling Aquacel Ag Surgical SP surgical dressings (REF 413556, 9cm x 15cm size) because some were made thicker than the design specification. The …
ConvaTec, Inc
SUNS International SS6291 Elevator Switch Recall
SUNS International is recalling its SS6291 Solenoid Interlock Switch used in residential elevators. The switch can get stuck in a retracted position, leaving …
SUNS SS6291 Solenoid Interlock Switches
Remel GC Agar Base Recall
Remel GC Agar Base laboratory media may not properly recover some strains of Neisseria gonorrhoeae bacteria, potentially leading to missed or delayed diagnoses …
Remel, Inc
Medline Swan-Ganz Catheter Kits Recall
Medline Convenience kits containing Swan-Ganz catheters are being recalled due to failures in the blue proximal injectate lumen hub that can leak or break, …
Medline Industries, LP
Medline Swan-Ganz Catheters Recall
Medline Convenience kits containing Swan-Ganz catheters are being recalled because the blue proximal injectate lumen hub can leak, break, or fail, risking …
Medline Industries, LP
GORE VIABIL Biliary Endoprosthesis Recall
Some GORE VIABIL Short Wire Biliary Endoprosthesis devices were labeled with incorrect specifications. Devices marked as 10 mm diameter x 10 cm without drainage …
W L Gore & Associates, Inc.
Medline Convenience Kits Recall
Medline Convenience Kits containing Huons Lidocaine HCL Injection have been recalled due to quality issues found during an FDA inspection of the supplier's …
Medline Industries, LP
CRE Pro Wireguided Boston Scientific Recall
Boston Scientific's CRE Pro Wireguided devices (12-15mm, 240cm) have a potential sterile packaging breach. If the pouch was damaged or unsealed, the device …
Boston Scientific Corporation
Bard Poly Midline Catheter Recall
Bard Access Systems is recalling Poly Midline Catheters (models CK000495A and CK000566) because the lidocaine supplied with these catheters was made under …
Bard Access Systems, Inc.
RayCare 2024A SP1 Oncology Software Recall
RayCare 2024A SP1 oncology software can lose patient treatment data if beam set delivery notes are edited at the same time or changed during an active treatment …
RAYSEARCH LABORATORIES AB
U2 Total Knee System Adaptor Recall
United Orthopedic's U2 Total Knee System femoral valgus adaptor components have a defective screw that prevents proper assembly of the stem trail. This could …
United Orthopedic Corp.
Medtronic O-arm O2 Imaging System Recall
The Medtronic O-arm O2 Imaging System (Model BI70002000) can produce distorted or incorrect images due to a firmware defect in its detector panel. This imaging …
Medtronic Navigation, Inc.-Boxborough
Inspire Stimulation Lead 4063 Recall
Inspire Stimulation Lead (Model 4063) devices are labeled with incorrect expiration dates that extend beyond their validated three-year shelf life. Using an …
Inspire Medical Systems Inc.
Pilling Wecksorb Neurosponges Recall
Pilling Wecksorb Neurosponges, absorbent cotton sponges used to protect brain and spinal cord tissue during surgery, may contain unsafe levels of endotoxins, …
TELEFLEX LLC
Fresenius Bicarby Dialysate RFP-400-G Recall
Fresenius Bicarby Dialysate (Model RFP-400-G) has an incorrect barcode label that could lead to the wrong potassium concentration being used during dialysis. …
Fresenius Medical Care Holdings, Inc.
Draeger Atlan A350XL Anesthesia Workstation Recall
Draeger has recalled the Atlan A350XL anesthesia workstation (model 8621600) because the device may signal a piston ventilator failure before use, or the …
Draeger, Inc.
B. Braun Spinocan Spinal Needle Kit Recall
B. Braun Medical is recalling three Spinocan spinal needle procedure kits that contain Bupivacaine 0.75% with Dextrose 8.25% injection. The bupivacaine inside …
B Braun Medical Inc
Medline Medical Procedure Kits Recall
Medline Medical Procedure Kits used in cardiac and vascular surgeries have defects in catheter quality, including surface irregularities, loose connectors, and …
Medline Industries, LP
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