GE Healthcare SIGNA Premier MRI Recall
GE Healthcare SIGNA Premier MRI systems may have steel fittings instead of brass in the magnet assembly. If a technician accesses the system while the magnet is …
GE Healthcare 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.
125 recalls · updated Jun 11, 2026
Medline NAMIC Angiographic Syringe Recall
Medline Industries is recalling several sizes of NAMIC Angiographic Control Syringes because the rotating adaptor may unwind during use, causing the syringe to …
Medline Industries, LP
Medline NAMIC RA Control Syringe Kit Recall
Medline has recalled three medical convenience kits containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes. The rotating adaptor on the syringe …
Medline Industries, LP
Medline Convenience Kits Syringes Recall
Medline Convenience Kits containing 10mL polycarbonate colored syringes are being recalled due to unapproved design changes that were not reviewed by the FDA. …
Medline Industries, LP
Medline 10mL Syringes Convenience Kits Recall
Medline has recalled certain 10mL polycarbonate colored syringes in its Convenience Kits due to unapproved design changes that were not reviewed by the FDA. …
Medline Industries, LP
Medline Namic Guidewires Recall
Medline has recalled certain Namic Guidewires used in medical procedures because their regulatory clearances have been rescinded and they should no longer be …
Medline Industries, LP
Medline Heart Transplant Biopsy Kit Recall
Medline Heart Transplant Biopsy Kit (Model DYNJ37543A) is being withdrawn because certain components, Control Syringes, Guidewires, and/or High-Pressure Tubing, …
Medline Industries, LP
Masimo Radius VSM ECG Set Recall
Masimo's Radius VSM ECG pre-connected set may incorrectly detect abnormal heart rates in patients with normal rhythms, potentially triggering false alarms that …
Masimo Corporation
XTANT MEDICAL Xpress Pedicle Screw Recall
XTANT MEDICAL Xpress Pedicle Screw System units (Part Number X073-6555-DL, 6.5 x 50 mm) from one lot were mislabeled with an incorrect part number, making the …
XTANT Medical Holdings, Inc
Artoura Breast Tissue Expanders Recall
Artoura Breast Tissue Expanders may come with infusion set needles that are dull or blunt, making them difficult to advance and risking breakage during use. …
Mentor Texas, LP.
Medline Thoracic Robot DYNJ908777B Recall
Medline thoracic robot kits contain recalled Olympus biopsy valves that may shed rubber fragments. These fragments can lodge in the airway and require surgical …
Medline Industries, LP
Medtronic MiniMed Paradigm Pump Insulin Recall
Medtronic MiniMed Paradigm REAL-Time insulin pumps can deliver too much or too little insulin depending on how the pump is positioned relative to the infusion …
Medtronic MiniMed, Inc.
Medtronic MiniMed 720G Insulin Pump Recall
Medtronic MiniMed insulin pumps can deliver too much or too little insulin depending on the pump's height relative to the infusion site. Over-delivery can cause …
Medtronic MiniMed, Inc.
Burlington Medical Wrap Aprons Recall
Burlington Medical Wrap Aprons may degrade over time, which could reduce their protective lifespan. The manufacturer has voluntarily recalled these aprons.
Burlington Medical, LLC
Orthalign Drill Plate Recall 402567
Orthalign's Drill Plate component for the Lantern Knee System (Trimax, Size 6-7, REF 402567) may be manufactured out of specification, causing the device to cut …
Orthalign, Inc
Orthalign Drill Plate Lantern Knee System Recall
Orthalign's Drill Plate component for the Lantern Knee System can be manufactured out of specification, causing bone cuts larger than intended during surgery. …
Orthalign, Inc
React Health PHOENIX 5L Oxygen Concentrator Recall
Some React Health PHOENIX 5L Oxygen Concentrators were shipped without passing quality checks. The devices may not work as intended, which could affect oxygen …
3B Medical, Inc.
Olympus MAJ-210 Biopsy Valve Recall
Olympus single-use biopsy valves (Model MAJ-210) may shed rubber fragments during use. Healthcare providers should stop using affected units and contact Olympus …
Olympus Corporation of the Americas
Olympus MAJ-1218 Biopsy Valve Recall
Olympus Single Use Biopsy Valve (Model MAJ-1218) has been recalled because rubber fragments can detach during use. If fragments enter the endoscope or are not …
Olympus Corporation of the Americas
B. Braun CESK Harris Methodist Recall
B. Braun's CESK Harris Methodist adhesive component (model 555498) contains tubing that may crack during manufacturing, making it unusable. The defect was …
B Braun Medical Inc
Abiomed Impella RP Flex SmartAssist Recall
Abiomed has recalled the Impella RP Flex with SmartAssist heart pump (Product Code 1000323) because a pressure sensor inside the device may malfunction and give …
Abiomed, Inc.
I.T.S. HCS Headless Compression Screw Recall
I.T.S. GmbH's HCS Headless Compression Screw System may heat up more than expected during MRI scans. The manufacturer has updated safety information to reflect …
I.T.S. GmbH
I.T.S. Foot Locking Plates & Hallux Osteotomy Recall
The FLS Foot Locking Plates System and HOL Hallux Osteotomy Locking Plate may heat up more than expected during an MRI scan. Updated safety testing found higher …
I.T.S. GmbH
GEM Premier 5000 PAK Cartridge Recall
GEM Premier 5000 PAK cartridges may repeatedly eject during warm-up due to detection errors, requiring cartridge replacement and potentially delaying test …
Instrumentation Laboratory
First Aid Only BZK Antiseptic Towelette Recall
First Aid Only BZK Antiseptic Towelettes (5x7 bulk size) are being recalled due to manufacturing defects. The product may not meet quality standards for an …
ACME UNITED CORPORATION
MediHoney Gel Leptospermum Recall
MediHoney Gel with Active Leptospermum Honey wound dressings (models 31805 and 31815) are being recalled due to potential packaging failures that could …
Integra LifeSciences Corp. (NeuroSciences)
Endo-Model Replacement Plateau Recall
The Endo-Model Replacement Plateau implant (Item Number 15-0027/11) is being recalled because the bushing on the plateau screw can detach from the shaft due to …
Waldemar Link GmbH & Co. KG (Mfg Site)
Medline Dialysis On/Off Kit Recall
Medline Dialysis On/Off Kits with Tego Connectors may have defective silicone seals that can tear or dome, blocking fluid flow during dialysis or causing …
Medline Industries, LP
Medline Dialysis Dressing Change Kit Recall
Medline dialysis dressing change convenience kits with Tego Connectors may have defective silicone seals that can tear or dome, blocking the fluid path and …
Medline Industries, LP
Medline Convenience Kits Recall
Medline is recalling multiple surgical convenience kits due to sterilization equipment calibration issues that may have compromised the sterility of these …
Medline Industries, LP
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