Medical Device Recalls
RSS ↗8,689 medical device recalls from federal enforcement feeds.
Showing 6,701–6,750 of 8,689
- Class II
Medical Device Recall · May 17, 2024
The VASOVIEW HemoPro Endoscopic Vessel Harvesting Systems are designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope,Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead to the device not providing cautery or providing cautery when not intended.
- Class II
Medical Device Recall · May 17, 2024
SEASPINE ORTHOPEDICS CORPORATION
Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 35-55mm Model/Catalog Number: MR2102035 Product Description: Cranial Caudal Blade Component: Yes, a component of a retractor blaCranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure
- Class II
Medical Device Recall · May 17, 2024
SEASPINE ORTHOPEDICS CORPORATION
Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 50-80mm Model/Catalog Number: MR2102050 Product Description: Cranial Caudal Blade Component: Yes, a component of a retractor blaCranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure
- Class II
Medical Device Recall · May 17, 2024
Stimuplex A, 30 DEG, 24GX1", 0.55x25mm, Catalogue Number: 4894251.The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.
- Class II
Medical Device Recall · May 17, 2024
Stimuplex A, 30 DEG, 21GX4", 0.80x100mm, Catalogue Number: 4894260The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.
- Class II
Medical Device Recall · May 17, 2024
RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hip hemi-arthroplasty Item Number: 11-16520641 mm acetabular outer heads were potentially assembled with a 42 mm locking ring, may lead to joint instability leading requiring surgical intervention
- Class II
Medical Device Recall · May 17, 2024
The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the following: 1. VasoView Hemopro 2, Model Number: VH-4000. 2. VasoView Hemopro 2 with Vasoshield. Model Number: VH-4001. ThePotential for there to be a fluid ingress into the handle of the harvesting tool, which may lead to the device not providing cautery or providing cautery when not intended.
- Class II
Medical Device Recall · May 17, 2024
Cascade IOMAX Cortical Module, REF: 190296-200Electroneurodiagnostic medical device may contain a defective printed circuit board which may cause damage to the other internal components resulting in unintended electrical stimulation.
- Class I
Medical Device Recall · May 16, 2024
Inspire Model 3028, IV Implantable Pulse GeneratorThere is a potential manufacturing defect which can lead to electrical leakage in the sensing circuit which causes a system malfunction and requires a revision surgery to replace the IPG,
- Class II
Medical Device Recall · May 16, 2024
Proclaim 5 Elite Implantable Pulse Generator, REF 3660, Sterile EO, Rx OnlyThe duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
- Class II
Medical Device Recall · May 16, 2024
Abbott Proclaim XR 7 Implantable Pulse Generator, REF 3662, Sterile EO, Rx OnlyThe duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
- Class II
Medical Device Recall · May 16, 2024
Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx OnlyThe duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
- Class II
Medical Device Recall · May 16, 2024
Abbott Proclaim Plus 7 Implantable Pulse Generator, REF 3672, Sterile EO, Rx OnlyThe duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
- Class II
Medical Device Recall · May 16, 2024
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Allura Xper FD20 system with an ADN7NT patient table. Model Number: 722012, Software Version Number 8.1.100.When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table.
- Class II
Medical Device Recall · May 16, 2024
Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLYDeep brain stimulation system will first turn off after approximately 50 days after the system is activated and subsequently, this same action will recur approximately every 50 days thereafter. This unexpected lost of stimulation may result in loss of therapy.
- Class II
Medical Device Recall · May 16, 2024
Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3670, Sterile EO, Rx OnlyThe duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
- Class II
Medical Device Recall · May 16, 2024
Abbott Proclaim DRG Implantable Pulse Generator, REF 3664, Sterile EO, Rx OnlyThe duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
- Class II
Medical Device Recall · May 16, 2024
Abbott Proclaim 7 Implantable Pulse Generator, REF 3667, Sterile EO, Rx OnlyThe duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
- Class II
Medical Device Recall · May 16, 2024
Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3671, Sterile EO, Rx OnlyThe duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
- Class II
Medical Device Recall · May 16, 2024
Abbott Proclaim 5 Implantable Pulse Generator, REF 3665, Sterile EO, Rx OnlyThe duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
- Class II
Medical Device Recall · May 16, 2024
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0104 (6 kit test) The BIOFIRE FILMARRAY GastrointestiDue to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium.
- Class II
Medical Device Recall · May 16, 2024
Proclaim 7 Elite Implantable Pulse Generator, REF 3662, Sterile EO, Rx OnlyThe duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
- Class II
Medical Device Recall · May 16, 2024
Abbott Proclaim 7 Implantable Pulse Generator, REF 3663, Sterile EO, Rx OnlyThe duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
- Class II
Medical Device Recall · May 16, 2024
Abbott Proclaim 5 Implantable Pulse Generator, REF 3661, Sterile EO, Rx OnlyThe duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
- Class II
Medical Device Recall · May 16, 2024
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Allura Xper FD20 Biplane system with an ADN7NT patient table. Model Number: 722013, Software Version Number 8.1.100.When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table.
- Class II
Medical Device Recall · May 16, 2024
TourniKwik Tourniquet Set (CFN 79012)Incorrect component placed in four manufactured lots of the TourniKwik" Tourniquet Set.
- Class II
Medical Device Recall · May 16, 2024
Fresenius Medical Care Holdings, Inc.
US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic Part Numbers: G02020110 Fresenius Part Number: 24-090A-1Concentrate Flow was exceeding the maximum 19.9 bar set point. The standard default set point range is between 4 and 18.Error message (F020104, "concentrate pressure alarm limit exceeded") concentrate pressure is too high and stops the dialysis water supply.
- Class II
Medical Device Recall · May 16, 2024
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Allura Xper FD10 system with an ADN7NT patient table. Model Number: 722010, Software Version Number 8.1.100.When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table.
- Class I
Medical Device Recall · May 15, 2024
Ventilator HAMILTON-C6, PN: 160021Ventilator may enter sensor fail mode, ventilation may not re-initiate, after patient is reconnected, which may cause hypoxia, if this sequence occurs: 1)User presses O2 enrichment, 2)User disconnects endotracheal tube for open suctioning, 3)Sensor error initiated, sensor fail mode occurs, 4)Patient is re-connected with sensor fail mode active, 5) Ventilation is not re-initiated by the ventilator.
- Class II
Medical Device Recall · May 15, 2024
KNEE SCOPE Procedure tray Catalog Number: COKN48LEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
KNEE ARTHROSCOPY PACK-Procedure Kit Catalog Number: WEKA15BEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
A610 Clinician Programmer (CP) Software Application (app) with the following versions: Version 2.0.x (2.0.4584, 2.0.4594, 2.0.4605, 2.0.4630, and 2.0.4648), Version 3.0.x (3.0.1057, 3.0.1062, 3.0.1081Patients implanted with a pocket adaptor (Model 64001 and/or 64002) are limited to HEAD ONLY MRI eligibility.
- Class II
Medical Device Recall · May 15, 2024
ACL, ST LUKES METHODIST 1CS Catalog Number: LMAC10AAEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
KNEE ARTHROSCOPY-Procedure Kit Catalog Number: SLAR14GEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
HAND PACK 297829--Procedure Kit Catalog Number: RGHN04IEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
KNEE ARTHROSCOPY PACK-Procedure Kit Catalog Number: SFAR60AEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
TOTAL KNEE -Procedure Kit Catalog Number: QPTK95AEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
TOTAL KNEE, ST LUKES Catalog Number: LMTK17APEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
KNEE ARTHROSCOPY PACK Catalog Number: MEKA12REthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
UPPER EXTREMITY PK, STRL F G Catalog Number: IHUE40AGEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
BPKN15C KNEE BASIN PACK BHS- Procedure tray Catalog Number: BPKN15CEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
ARTHRO KNEE BEACHES PACK BHS- Procedure tray Catalog Number: BPKB46BEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
HAND WRIST FOREARM-LF Procedure tray Catalog Number: CCHD17BEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
KNEE ARTHROSCOPY-Procedure Kit Catalog Number: QPKA35AEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
ARTHROSCOPY WOLFSON PACK BHS Procedure tray Catalog Number: BPAR65AEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
AHAR50K STANDARD ARTHROSCOPY PACK - 291852. Procedure tray Catalog Number: AHAR50KEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
Happiest Baby, Inc Pre-loved SNOO Smart Sleeper Model:S1000This recall is retroactively being reported. Refurbished bassinets failed to meet quality standards prior to distribution.
- Class II
Medical Device Recall · May 15, 2024
ARTHROSCOPY SUP JOI PACK Procedure tray Catalog Number: BPAS17CEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
HAND PACK-Procedure Kit Catalog Number: WEHD16BEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter ULT16.0-38-25-P-6S-MCL-HC--Intended for percutaneous drainage in a variety of drainage applications (e.g., nephrostomy, biliary and absceProduct labels state the incorrect expiration dates that extends beyond their true expiration date