Lead medical devices recalls
39 FDA Class I medical devices recall events since Jan 1, 2025 whose stated reason matches “Lead”. Grouping is by keyword in FDA's reason text — see methodology.
Recalls
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Draeger, Inc. medical device recall: VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310…
Potential cracks in the hose, which could lead to leakage or the hose falling off.
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CooperSurgical, Inc. medical device recall: Inca
Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pressure,…
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Medline Industries, LP medical device recall: Medline Convenience Kits: 1) KIT ANESTHESIA L&D A- LINE SET
The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of…
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Bd Switzerland Sarl medical device recall: BD Alaris Pump Infusion Sets 10561554* 10885403232565 50885403232563…
Due to discrepancies in specific attributes in the performance data for infusion sets, which may lead to inappropriate pump performance.
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Boston Scientific Neuromodulation Corporation medical device recall: Infinion Cx Lead Kit
Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high impedance measurements or lead fractures, which may lead to…
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Medline Industries, LP medical device recall: Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item…
Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of residual material. If devices with residual particulates on…
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Baxter Healthcare Corporation medical device recall: Hillrom VOLARA System P.CIRCUIT KIT
There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level…
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Insulet Corporation medical device recall: Omnipod 5 Pods. Includes the below Model/REF Numbers: 1.…
External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus…
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Arrow International, LLC medical device recall: Paracentesis Kit
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and…
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Kayserbetten Gmbh & Co. Kg medical device recall: Pediatric care bed
If the adjustment functions of the hand control, as instructed in the Manual, are not locked with the provided key when the patient (child) is unattended, there is an…
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Abiomed, Inc. medical device recall: Automated Impella Controller
Retrospective submission for following issues identified: 1. Alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing were…
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Abiomed, Inc. medical device recall: Automated Impella Controller
A retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. These hardware updates have been…
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Ventec Life Systems, Inc. medical device recall: VOCSN V+Pro package
Respiratory system intended to provide continuous/intermittent ventilator support, may not have been evaluated under all intended high-pressure conditions during…
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North American Rescue LLC. medical device recall: AIDBAGs are first aid kits of convenience composed of individually…
Kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that has been recalled for an issue with the software design of the E-5 Error Code…
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Insulet Corporation medical device recall: Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS…
Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have an internal soft cannula tear that results in insulin leaking into the Pod instead of being…
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Trividia Health, Inc. medical device recall: Owner's Booklets and Instructions for Use that are used with the…
The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and…
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Olympus Corporation of the Americas medical device recall: Olympus High Flow Insufflation Unit. Model Number: UHI. Used for…
Issue with software algorithm which may lead to overpressure events.
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Medline Industries, LP medical device recall: Medline ReNewal Reprocessed Webster CS Catheters: Webster CS Catheter…
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic…
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Medline Industries, LP medical device recall: Anesthesia Circuit Kits and other various kits that contain…
Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia,…
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Medline Industries, LP medical device recall: Reprocessed Livewire Steerable Electrophysiology Catheter Item…
Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on…
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Abiomed, Inc. medical device recall: Automated Impella Controller
Specific Automated Impella Controllers (AICs) that have a Pump Driver Circuit Assembly do not meet current specifications. This may lead to decreased pump performance or…
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Dexcom, Inc. medical device recall: Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product…
The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) and…
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Tandem Diabetes Care, Inc. medical device recall: Battery Operated infusion pumps. t:slim X2 G5
Insulin pumps manufactured with speakers from Revision A and B may malfunction ("Malfunction 16") which prevents audible alerts and causes the pumps to become inoperable…
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Boston Scientific Corporation medical device recall: Endotak Reliance G/Sg
Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early…
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Hamilton Medical AG medical device recall: Breathing circuit set
Ventilator coaxial breathing circuit may have a crack in blue tubing, which is used to deliver fresh gas to the patient. The crack will compromise inspiratory and…
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Given Imaging Ltd. medical device recall: Bravo CF capsule delivery device
It has been determined that misapplied adhesive on the Bravo CF capsule delivery device may lead to its malfunction. Specifically, the misapplied adhesive may prevent…
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SunMed Holdings, LLC medical device recall: Broselow Pediatric Emergency Rainbow Tape
The impacted tape was manufactured with incorrect information on the tape. Incorrect values are printed in the Red zone, Orange zone, and Grey zone. Using the incorrect…
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Dexcom, Inc. medical device recall: Dexcom G6 Glucose Receiver
Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or high blood…
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SunMed Holdings, LLC medical device recall: Adult Manual Resuscitator with Medium Adult Mask
Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient port instead of the exhalation port). If not noticed prior to patient…
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Smiths Medical ASD, Inc. medical device recall: CADD Solis HSPCA Pump ***Updated 5/27/26*** Scope updated to apply…
Pumps may experience Wireless Connection Modules intermittent connection alarms, which will interrupt an active infusion. Interruption or delay of therapy can lead to…
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Smiths Medical ASD, Inc. medical device recall: CADD-Solis HPCA Ambulatory Infusion Pump
Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of…
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Bard Access Systems, Inc. medical device recall: BD 4 Fr Single-Lumen PowerPICC Catheters
Catheters indicated for short-or-long term access to the central venous system have tubing that exceeded melt flow index specification (higher), which could lead to…
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Tandem Diabetes Care, Inc. medical device recall: t:slim X2 Insulin Pump with Interoperable Technology
A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, will cause the pump to…
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Calyxo, Inc. medical device recall: CVAC Aspiration System
Aspiration system, for endoscopic examination/treatment of urinary tract and kidney interior, to have labeling update adding additional instructions, for patients with…
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Bard Peripheral Vascular Inc medical device recall: Rotarex Atherectomy System and Instructions for Use
Atherectomy Catheter eIFU updated to clarify and emphasize procedural steps intended to reduce the likelihood of catheter breakage events. Catheter has an outer cylinder…
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Micro Therapeutics, Inc. medical device recall: Medtronic Pipeline Vantage Embolization Device with Shield Technology
Use of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wall apposition and/or braid deformation (fish-mouthing/braid…
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Getinge Usa Sales Inc medical device recall: Vaporizer Sevoflurane
Sevoflurane used with the vaporizer may degrade to hydrogen fluoride, which could present a risk to patients or health care providers through inhalation and/or skin…
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Baxter Healthcare Corporation medical device recall: Welch Allyn
There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
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Nova Biomedical Corporation medical device recall: StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685.…
A software bug within the Gen 2 StatStrip Hospital Meter firmware leads to transmission of erroneous glucose patient test results to a healthcare institution's data…