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
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
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.
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
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.
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