CGuard Prime Carotid Stent Recall
The CGuard Prime Carotid Stent System (model CND0840) may encounter deployment complications that prevent the stent from being placed properly during the …
INSPIREMD Inc
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
Surgify Halo Surgical Burr Recall
Surgify Halo 5.4 mm Medium burr drills (Model 54.085.SHD.H1) used in spinal surgery can break during the procedure. A broken burr could complicate surgery or …
SURGIFY MEDICAL OY
Residential Elevators StrikeLock Door Lock Recall
Residential Elevators is recalling its StrikeLock hoistway door locking device, which is used to secure a landing door on residential elevators. The device can …
Residential Elevators StrikeLock Hoistway Door Locking Device
Avanos MIC Safety PEG Kit Recall
Avanos Medical's MIC Safety Percutaneous Endoscopic Gastrostomy (PEG) Kit 24 Fr PUSH OTW (Model 7170-24) contains lidocaine hydrochloride injection with quality …
Avanos Medical, Inc.
Avanos CORFLO Safety PEG Kit Recall
Avanos Medical is recalling CORFLO Safety PEG kits with ENFit connectors because they contain lidocaine injection from a supplier with quality issues. This …
Avanos Medical, Inc.
CORFLO Safety PEG Kit ENFit Connector Recall
Avanos Medical is recalling the CORFLO Safety PEG Kit with ENFit Connector (Model 50-4320) because some kits contain lidocaine hydrochloride injection with …
Avanos Medical, Inc.
BD Spinal Tray Whitacre Needle 405645 Recall
Becton Dickinson is recalling a spinal anesthesia tray because one of its drug components, bupivacaine hydrochloride in dextrose injection, was made at a …
Becton Dickinson & Company
Covidien Mon-a-Therm Temperature Probe Recall
Covidien Mon-a-Therm temperature probe (9 Fr, REF 90050) was sold without FDA clearance. The company initiated a voluntary withdrawal because these devices lack …
Covidien LLC
BD PurPrep Povidone-Iodine Recall
BD PurPrep povidone-iodine sterile skin prep solution (25 applicators per carton) may not be sterile due to potential product contamination. Using a non-sterile …
CareFusion 213, LLC
BD PurPrep Povidone-Iodine Recall
BD PurPrep povidone-iodine sterile solution applicators (10.5 mL, 25-pack) are being recalled because the manufacturer cannot confirm they are properly …
CareFusion 213, LLC
GE Allia IGS 3 Pulse X-ray System Recall
An electrical cable defect in certain GE Allia IGS 3 Pulse angiographic X-ray systems equipped with Gaia generators poses a risk of electrical shock to service …
GE Medical Systems, LLC
Philips SmartPath dStream MRE Recall
Philips SmartPath to dStream 3.0T MR Elastography systems can produce incorrect stiffness measurements when certain image settings are used together. This may …
Philips North America
Physio-Control LIFEPAK Defibrillator Recall 2026
Physio-Control is recalling certain LIFEPAK defibrillators that were serviced between July 2023 and November 2025 without confirmed completion of a required …
Physio-Control, Inc.
BARD Dynamic Tip Steerable Recall
The BARD Dynamic Tip Steerable medical device (Product Number 6DYNTP001) has incomplete seals on its sterile packaging, which could allow contamination. The …
Stryker Sustainability Solutions
BARD Dynamic Deca Steerable Recall
BARD Dynamic Deca Steerable electrophysiology catheters (Product Number 201101) have incomplete seals on their sterile packaging, which could allow …
Stryker Sustainability Solutions
BD GasPak EZ CO2 Pouch Recall
BD GasPak EZ CO2 Pouch System (Catalog Number 260684) gas-generating sachets may produce carbon dioxide levels below the specified amount, potentially affecting …
Becton Dickinson & Co.
MicroVention LVIS Stent Device Recall
MicroVention's LVIS Intraluminal Support Device (stent) may have incorrect dimensions or configuration due to a manufacturing issue. If the stent is the wrong …
MICROVENTION INC.
One Step K Diagnostic Test Recall
One Step K in vitro diagnostic test (model REF: 81A4) is being recalled because it was distributed without required FDA clearance. The safety and effectiveness …
DFI Co., Ltd.
GE Revolution CT ES Security Vulnerability Recall
GE Medical Systems has identified a security vulnerability in the AW Server software used in certain Revolution Apex, Revolution Ascend, and Revolution CT …
GE Medical Systems, LLC
Olympus OER-ELITE Endoscope Tubes Recall
Olympus has recalled OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2115) due to a defect that could affect proper sterilization and reprocessing …
Olympus Corporation of the Americas
Remel Yeastone Broth Recall
Remel Yeastone Broth test kits may give incorrect results during quality control checks, potentially delaying treatment decisions for fungal infections. …
Remel, Inc
Medline Heart Cath Pack-LF Manifold Recall
Medline has recalled its Heart Cath Pack-LF medical convenience kits (kit number DYNJ36478B) because particulate matter was found inside the fluid path of the …
Medline Industries, LP
Olympus Thunderbeat II Shears Recall
Olympus Thunderbeat II Shears (Model TB2-0545FC) can lose a component from the tip during surgery, potentially leaving debris in the patient. If you use this …
Olympus Corporation of the Americas
Gentuity HF-OCT Imaging System Recall
The Gentuity HF-OCT Imaging System Model G10-01 with certain software versions can produce repeated frames during imaging pullbacks, which may lead to …
Gentuity, LLC
Prodisc C SK PDSXL5 Implant Recall
Centinel Spine has recalled Prodisc C SK Extra Large cervical disc replacement implants because some 5mm implants were mislabeled as 6mm, and some 6mm implants …
Centinel Spine, Inc.
Medline Neuro Sponges Recall
Medline Neuro Sponges in multiple sizes have been found to contain higher-than-expected endotoxin levels, which can cause serious reactions if used in sterile …
Medline Industries, LP
Medline Spine Pack Neuro Sponges Recall
Medline is recalling medical procedure kits containing Neuro Sponges (SPINE PACK-LF, SKU PHS719414B) because they may have higher-than-expected endotoxin …
Medline Industries, LP
Medline Neuro Sponges Kit Recall
Medline is recalling certain medical procedure kits containing Neuro Sponges due to higher-than-expected endotoxin levels, which may not meet safety …
Medline Industries, LP
Medline Microdisectomy Pack Recall
Medline Microdisectomy Packs containing Neuro Sponges have higher-than-expected endotoxin levels, which can cause infection or inflammatory reactions during …
Medline Industries, LP
Medline Neuro Sponge Procedure Kits Recall
Medline medical procedure kits containing neuro sponges have been recalled because some units contain higher-than-expected endotoxin levels, which can cause an …
Medline Industries, LP
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