Medical Device Recalls

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8,689 medical device recalls from federal enforcement feeds.

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Showing 4,951–5,000 of 8,689

Medical Device Recall · December 13, 2024
Trinity Sterile, Inc.
Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Transparent Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Number: DC3077LF Software Version: N/A Product Description: Dress
Potential for hole in package compromising sterility of the medical kit.
Class II
Medical Device Recall · December 13, 2024
Trinity Sterile, Inc.
Brand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep 3mL & HaloGUARD Model/Catalog Number: IM46062 Software Version: N/A Product Description: Dressing change kit, case of 30
Potential for hole in package compromising sterility of the medical kit.
Class II
Medical Device Recall · December 13, 2024
Hologic, Inc.
Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.
Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or incorrect results leading to a possible delay of treatment.
Class II
Medical Device Recall · December 13, 2024
Trinity Sterile, Inc.
Brand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa & Statlock CS/30 Model/Catalog Number: DC5090LF Software Version: N/A Product Description: Dressing change kit, case of
Potential for hole in package compromising sterility of the medical kit.
Class II
Medical Device Recall · December 13, 2024
Trinity Sterile, Inc.
Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Cloth Border Tegaderm Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Number: DC3080LF Software Version: N/A Product Descript
Potential for hole in package compromising sterility of the medical kit.
Class II
Medical Device Recall · December 13, 2024
Trinity Sterile, Inc.
Brand Name: Tacy Medical, Inc. Product Name: Dressing Change Tray CS/20 Model/Catalog Number: TM6180CP Software Version: N/A Product Description: Dressing change tray, case of 20, lot #600032, 50
Potential for hole in package compromising sterility of the medical kit.
Class II
Medical Device Recall · December 12, 2024
Medtronic Perfusion Systems
EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr)
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
Class II
Medical Device Recall · December 12, 2024
Boston Scientific Corporation
VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)
A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.
Class I
Medical Device Recall · December 12, 2024
LivaNova USA, Inc.
SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System. Used for Vagus Nerve Stimulation (VNS).
Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanically activated component that may become stuck in a closed position, which may result in patients returning to baseline seizure frequency or depressive symptoms and in the longer term, patients may be required to undergo generator replacement surgery to replace their device.
Class II
Medical Device Recall · December 12, 2024
Abiomed, Inc.
Impella RP Flex with SmartAssist; Product Number: 1000323;
Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm and loss of Central Venous (CV) Placement Signal, Pulmonary Artery (PA) Placement Signal & Pulmonary Artery Pulse Index (PAPi) metrics. Abiomed is reinforcing that there is a risk of potential interaction between the tip of guidewires, indwelling central venous lines or devices and inlet of the Impella pumps listed above during the insertion, manipulation, and removal of those devices. The interaction may result in optical sensor damage, temporary pump stop, or permanent pump stop.
Class I
Medical Device Recall · December 12, 2024
Abiomed, Inc.
Impella RP with SmartAssist; Product Number: 0046-0035;
Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm and loss of Central Venous (CV) Placement Signal, Pulmonary Artery (PA) Placement Signal & Pulmonary Artery Pulse Index (PAPi) metrics. Abiomed is reinforcing that there is a risk of potential interaction between the tip of guidewires, indwelling central venous lines or devices and inlet of the Impella pumps listed above during the insertion, manipulation, and removal of those devices. The interaction may result in optical sensor damage, temporary pump stop, or permanent pump stop.
Class I
Medical Device Recall · December 12, 2024
Boston Scientific Corporation
ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722)
A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.
Class I
Medical Device Recall · December 12, 2024
Boston Scientific Corporation
ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model Number L331)
A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.
Class I
Medical Device Recall · December 12, 2024
Medtronic Perfusion Systems
Select Series Angled Tip Arterial Cannula, Model Number 72422 (22 Fr)
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
Class II
Medical Device Recall · December 12, 2024
Boston Scientific Corporation
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.
Class I
Medical Device Recall · December 12, 2024
LivaNova USA, Inc.
SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation. Used for Vagus Nerve Stimulation (VNS).
Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanically activated component that may become stuck in a closed position, which may result in patients returning to baseline seizure frequency or depressive symptoms and in the longer term, patients may be required to undergo generator replacement surgery to replace their device.
Class II
Medical Device Recall · December 12, 2024
Medtronic Perfusion Systems
DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
Class II
Medical Device Recall · December 12, 2024
Boston Scientific Corporation
ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI (Model Number L131)
A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.
Class I
Medical Device Recall · December 12, 2024
Boston Scientific Corporation
VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228)
A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.
Class I
Medical Device Recall · December 11, 2024
MICROVENTION INC.
MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22 mm, WL 18 mm, Sterile R, CE0297. The intended purpose of the LVIS Device is to serve as a stent-assisted coili
Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer.
Class II
Medical Device Recall · December 11, 2024
HF Acquisition Co LLC
Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12 HealthFirst Mail In Monitoring System, 12 Tests, Item: 1003580
Spore test strip monitoring system, designed for routine monitoring of sterilization processes, may have a printing error on the return envelope that may cause spore test results to be reported to the incorrect customer's account.
Class II
Medical Device Recall · December 11, 2024
Nuwellis Inc
nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is used with the Aquadex SmartFlow or Aquadex FlexFlow System
The AquaFlexFlow UF 500 Plus extracorporeal blood circuit used with the Aquadex SmartFlow and FlexFlow Systems may indicate "Ultrafiltrate Weight Mismatch" or Excessive Weight Mismatch Alarms while in use. If not addressed, this failure could result in excess fluid removal from a patient leading to Acute Volume Depletion. This failure is especially serious when the Aquadex System is being used on pediatric patients.
Class I
Medical Device Recall · December 10, 2024
Encore Medical, LP
EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706
Knee insert package may contain an acetabular system, which may cause surgical delay to get a new product.
Class II
Medical Device Recall · December 10, 2024
Biocartis Nv
Idylla INSTRUMENT, IVD, REF P0010. Intended for the detection of nucleic acid targets in various types of human samples, using disposable Test-specific ldylla Cartridges.
False-positive MSI-H results generated by the Idylla MSI Test.
Class II
Medical Device Recall · December 10, 2024
ev3 Inc
Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM; 2) AB14W050020150, Size: 5MM X 20MM X 150CM; 3) AB14W050040090, Size: 5MM X 40
There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots.
Class II
Medical Device Recall · December 10, 2024
Mercury Enterprises, Inc. dba Mercury Medical
Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 1050832, 1050839, 1050840, 1050841, 1050842
Gas powered emergency resuscitator has a circuit flow controller manufactured with an undersized spring, which may cause resuscitator not reach the high and low ends of the PIP and PEEP pressure ranges, which may cause a loss of positive pressure, impacting effective ventilation of the patient.
Class I
Medical Device Recall · December 9, 2024
Maquet Cardiovascular, LLC
Vasoview Hemopro 2 (w/Vasoshield) Endoscopic Vessel Harvesting System. Model Numbers: VH-4001. Indicated for use in minimally invasive surgery allowing access for vessel harvesting.
Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool
Class I
Medical Device Recall · December 9, 2024
JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD
JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L
Oxygen concentrator may melt or catch on fire during use.
Class I
Medical Device Recall · December 9, 2024
Maquet Cardiovascular, LLC
VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. Indicated for use in minimally invasive surgery allowing access for vessel harvesting.
Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool
Class I
Medical Device Recall · December 6, 2024
DDS Lab
Temporary Titanium Abutments
Certain definitive dental implant restoration cases may have included a temporary titanium abutment (cylinder), rather than a definitive titanium abutment, which may lead the titanium abutment fracture, which may risk loosening of the affixed restoration; fragments could also injure oral mucosa, and could be aspirated.
Class II
Medical Device Recall · December 6, 2024
GE Medical Systems, LLC
Portrait Core Services, a set of software services that enable the communication and interaction of the Portrait Mobile Monitoring Solution components and will integrate into existing healthcare facil
There is a software issue that can result in the loss of patient monitoring on the Portrait Central Viewer Application after 425 days of continuous run-time.
Class II
Medical Device Recall · December 6, 2024
Fresenius Kabi USA, LLC
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Potential pneumatic valve failure that may cause the LVP to stop an active infusion and/or could prevent the pump from being used.
Class I
Medical Device Recall · December 5, 2024
Fresenius Medical Care Holdings, Inc.
Dialyzer Optiflux 160NRe
Potential for internal blood leaks due to cracked polyurethane
Class II
Medical Device Recall · December 5, 2024
QUIDEL ORTHO
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Model/Catalog Number: 8343386 Software Version: Not Applicable Product Description: The VITROS DGXN Slide
Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause negatively biased digoxin results.
Class II
Medical Device Recall · December 5, 2024
QUIDEL ORTHO
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Model/Catalog Number: 8343386 Software Version: Not Applicable Product Description: The VITROS DGXN Slide
Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause negatively biased digoxin results.
Class II
Medical Device Recall · December 5, 2024
Waldemar Link GmbH & Co. KG (Mfg Site)
LINK MP Reconstruction System Neck Segment (with suture holes, standard, uncemented, L= 35 mm, CCD 126¿, Offset= 31 mm, Ti6Al4V, PoroLink, Taper 12/14. Item Number: 99-0984/32 Intended for rev
Error on the main label and the patient label. The labels indicate a size XXL, this is a standard-size neck segment.. All further information on the labels is correct (Length, CCD and Offset).
Class II
Medical Device Recall · December 4, 2024
Augustine Temperature Management, LLC
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC71, 2) Model # WC71R (refurbished); used in conjunction with Warming Blankets
Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining to Power-on self-test error code "EA POST".
Class II
Medical Device Recall · December 4, 2024
Augustine Temperature Management, LLC
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Multiport, Models: 1) Model # WC77, 2) Model # WC77D (Demo), 3) Model # WC77R (Refurbished); used in conjunct
Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining to Power-on self-test error code "EA POST".
Class II
Medical Device Recall · December 4, 2024
Medtronic Navigation, Inc.
Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 The Sterile Percutaneous Reference Pin Set is intended to be used to place and rem
Due to an increase in complaint that the percutaneous reference pin would not fit into the patient reference frame or percutaneous pin adapter.
Class II
Medical Device Recall · December 4, 2024
Augustine Temperature Management, LLC
Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and Mattresses.
Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining to Power-on self-test error code "EA POST".
Class II
Medical Device Recall · December 4, 2024
B. Braun Medical, Inc.
Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of analgesic/anesthetic agent to intrathecal space and epidural space for pain control. Model/Catalog Number: 530159
Incorrect catheter connector within the kit resulting in inability to provide a secure connection to the epidural catheter. The incorrect catheter connector is smaller than the required catheter connector and therefore is unable to be used to administer medication.
Class II
Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: ECONO STERILE SIMS UTERINE SND GRD 13"STER25, Model Numbers: 96-2478 (gynecological use)
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE WEITLANER RETR SH 2X3 4.5"CS25, Model Numbers: 96-2201A; 2) ECONO STERILE WEITLANER RETR BL 2X3 4.5"CS25, Model Numbers: 96-220
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCALPEL HDL #3 W/METRIC CS/25, Model Number 96-3500M
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE PROBE W/EYE CS/50, Model Number 94-5923; 2) ECONO STERIL" PROBE W/EYE 5.5" STERL CS/25, Model Number 96-2361; orthopedic probe
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE FREER ELEV DE S/B 7.25" CS/25, Model Number 96-2483 (multiple purpose); 2) ECONO STERILE LOCKE ELEV #94 NARROW STER 25, M
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VEIN HOOK 1.5MM STERILE CS/25, Model Number 96-4020M; 2) ECONO STERILE VEIN HOOK 2MM STERILE CS/25, Model Number 96-4021M; 3) E
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: ECONO STERILE CEMENT SPATULA #24 STRL CS/25, Model Number 96-2245M, mixing utensil, dental
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE" BUCK EAR CUR BL STR#0STRLCS/25, Model Number 96-2273; 2) ECONO STERILE" BILLEAU EAR LOOP MD STRL CS/25, Model Number 96-
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: ECONO STERILE IUD EXTRACTOR DBL HK 10.5"CS25, Model Number 96-4146A
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II