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
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
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
DonJoy IceMan Classic 3 Recall
The DonJoy IceMan Classic 3 cold therapy unit (Model 11-1424) is being recalled because a broken connector can temporarily interrupt your prescribed cold …
DJO, LLC
Boston Scientific VALITUDE & VISIONIST CRT-P Recall
Boston Scientific has recalled several models of its VALITUDE and VISIONIST cardiac resynchronization therapy pacemakers (CRT-Ps) because updated software …
Boston Scientific Corporation
Medline Blood Culture Kit Recall
Medline medical kits containing Webcol Large Alcohol Prep Pads are being recalled because the pads are non-sterile due to bacterial contamination. These kits …
Medline Industries, LP
AVID Medical Cardiac Cath Tray Shands JAX Recall
AVID Medical has recalled the Halyard Cardiac Cath Tray Shands JAX kit (models SHND401-04 and SHND401-05) because a syringe rotating adapter inside the kit may …
AVID Medical, Inc.
Insulet Omnipod 5 Pod Recall: PT-001662
Insulet Corporation is recalling certain Omnipod 5 Pods (model PT-001662) from 49 manufacturing lots because a defect in the soft cannula can cause insulin to …
Insulet Corporation
Arjo Tenor Patient Lift Recall
Certain Arjo Tenor mobile patient lifts may have a defective internal component in the actuator that could suddenly lose its ability to hold the load, causing …
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
LSL Healthcare Wound Closure Tray Recall
LSL Healthcare Wound Closure Tray Model 7554 contains alcohol prep pads that were not properly sterilized. Non-sterile materials used during wound closure can …
LSL Healthcare Inc.
Angiodynamics Soft-Vu Catheter Recall
Angiodynamics' Soft-Vu Angiographic Catheter (Kumpe, non-braided) has a manufacturing defect that may block the guidewire from passing through the catheter hub. …
Angiodynamics, Inc.
Philips ALLURA Xper FD20 Biplane Recall
The Philips ALLURA Xper FD20 Biplane X-ray system may fail to initiate imaging or produce only intermittent X-ray exposure when using the wired foot switch, …
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
AccuVu Angiographic Catheter Recall
AccuVu Angiographic Catheters with certain catalog and product numbers contain a manufacturing defect that may prevent a guidewire from passing through the …
Angiodynamics, Inc.
Philips Respironics Trilogy Evo Universal Ventilator Recall
Philips Respironics has recalled the Trilogy Evo Universal home ventilator running software version 1.05.15.00. When a non-pneumatic nebulizer is used with the …
Philips Respironics, Inc.
Philips Respironics Trilogy EV300 Ventilator Recall
Philips Respironics is recalling the Trilogy EV300 home ventilator running software version 1.05.15.00. When a non-pneumatic nebulizer is used with this device, …
Philips Respironics, Inc.
Civco eTRAX Needle System Recall
Civco Medical Instruments is recalling the eTRAX Needle System Starter Kit 18G (for Aurora Trackers) due to a programming error that may cause the needle tip …
Civco Medical Instruments Co. Inc.
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