Medical device recalls
Recalls
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Medline Industries, LP medical device recall: Medline kits containing Huons Co. Bupivacaine HCL in Dextrose…
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including…
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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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Bolton Medical Inc. medical device recall: RelayPro Thoracic Stent-Graft System
Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system.
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Arrow International, LLC medical device recall: Arrow Edge Hemodialysis Catheterization Product
16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as…
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Windstone Medical Packaging, Inc. medical device recall: Custom Convenience Kit containing recalled Medline Namic Angiographic…
Affected kits contain Medline Namic RA Syringes, which are recalled by their manufacturer due to risk of syringe rotating adapter unwinding during use, which may result…
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Medline Industries, LP medical device recall: Namic Angiographic Manifold
Medline has identified the presence of particulate within the fluid path of the Manifolds.
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Omnicell, Inc. medical device recall: Rolls of label stock used with the Omnicell i.v.Station. 1. Part…
Potential for mislabeled syringe produced by the i.v.STATION device.
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American Contract Systems Inc medical device recall: Convenience kits containing Medline Namic Angiographic Control…
Impacted kits contain syringes recalled by Medline Industries. Syringe rotating adaptor may unwind during use, which may result in a loose connection or full…
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Medical Action Industries, Inc. 306 medical device recall: Medical Action Industries Inc. Pack Cath BHH
Convenience kit contains a syringe in which the rotating adapter may unwind during use, resulting in a loose connection and/or full disconnection between the syringe and…
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AVID Medical, Inc. medical device recall: Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and…
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Cook Incorporated medical device recall: Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN…
Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device…
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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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Intuitive Surgical, Inc. medical device recall: Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05…
Reloads for curved-tipped stapler may potentially produce an incomplete staple line.
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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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Boston Scientific Corporation medical device recall: Boston Scientific Pacemaker
Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers…
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Whill, Inc. medical device recall: WHILL Model C2
Cyber vulnerability of BLE communication was found by CISA VDP program.
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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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B Braun Medical Inc medical device recall: B. Braun Hemodialysis Bloodlines
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
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Medline Industries, LP medical device recall: NAMIC Angiographic Syringe
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose…
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Philips Respironics, Inc. medical device recall: Philips Respironics Trilogy Evo
In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
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Baxter Healthcare Corporation medical device recall: Blue Ventilator Adapter Module
Urgent Medical Device Correction for the Volara system single-patient use circuit due to the potential that patients or caregivers may be unaware of a possible decrease…
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Abiomed, Inc. medical device recall: Purge Cassette
Increased risk of purge leaks with Generation 1 purge cassettes.
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Abiomed, Inc. medical device recall: Automated Impella Controller
Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation Impella 5.5 (0550-0008*)…
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Philips Respironics, Inc. medical device recall: Philips Respironics Trilogy Evo
Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the…
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Merit Medical Systems, Inc. medical device recall: CentrosFLO Hemodialysis Catheters
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay,…
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Navajo Manufacturing Company medical device recall: Handy Solutions Neck & Shoulders Heating Pad
If heating pad is folded while in use, the power density increases in the folded area causing excessive temperatures, which can also be caused by placing pad under the…
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Erbe USA Inc medical device recall: Flexible Cryoprobe
Probes may rupture/burst during activation
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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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Abiomed, Inc. medical device recall: Impella RP with SmartAssist. Product Code: 0046-0035
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
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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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Boston Scientific Corporation medical device recall: AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation…
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SunMed Holdings, LLC medical device recall: Brand Name: Broselow Product Name: Broselow Pediatric Emergency…
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
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Medline Industries, LP medical device recall: MEDLINE beds labeled as: 1) Semi Electric Basic Homecare Bed
Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical scenarios such as operating the bed…
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Abbott Diabetes Care, Inc. medical device recall: FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The…
Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
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AVID Medical, Inc. medical device recall: Halyard ORGAN RECOVERY OR PACK
Devices are not suitable for organ transplant.
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Alcon Research LLC medical device recall: Brand Name: Alcon Laboratories
Ophthalmic procedure packs may have incomplete seals affecting sterility.
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Draeger, Inc. medical device recall: Draeger Vapor 2000. Unheated
A certain component of affected devices was not delivered within specification and contained impurities.
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GE Medical Systems China Co., Ltd. medical device recall: GE Healthcare Carestation anesthesia system
Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in…
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Fresenius Kabi USA, LLC medical device recall: Ivenix Infusion System
Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
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Draeger, Inc. medical device recall: ErgoStar CM 40 Model/Catalog Number: MP01840 Airway connector for…
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
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Fresenius Kabi USA, LLC medical device recall: Ivenix Infusion System
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
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Glycar SA Pty., Ltd. medical device recall: SJM Pericardial Patch
The impacted lot may not meet the required tensile strength specification.
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Olympus Corporation of the Americas medical device recall: Brand Name: Single Use Ligating Device Product Name: Olympus…
Potential that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally fixed around patient anatomy.
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TMJ Solutions Inc medical device recall: TMJ Bilateral Implant REF: CHG020 Sterile EO
Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.
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CareFusion 303, Inc. medical device recall: BD Alaris infusion Pump Module 8100
If infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, which can cause under-infusion, over-infusion, unregulated flow, or pump…
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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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Siemens Medical Solutions USA, Inc medical device recall: MAGNETOM Cima.X Upgrade. Model Number: 11689304
There is a potential for an ice blockage to form or currently exist within the primary and/or the auxiliary venting paths of the magnet helium containment venting…
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Cerenovus Inc medical device recall: CEREPAK Detachable Coil System - Name/REF: UNIFORM 2MM X 2.5…
Detachable coils system may fail to detach, which could result in hemorrhagic and ischemic stroke, procedural delays, or the need for additional surgical intervention.
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Tandem Diabetes Care, Inc. medical device recall: Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps…
Insulin pump includes a vibration motor that gives tactile feedback for any alerts, alarms, or malfunctions. Pump may exhibit false vibration motor failure due to a…