Medical Device Recalls

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7,979 medical device recalls from federal enforcement feeds.

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Showing 6,351–6,400 of 7,979

Medical Device Recall · April 15, 2024
Philips North America Llc
Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728144
Metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive CT system, may become compromised, resulting in potential contact with other gantry components located within the Incisive CT system during rotation. Resulting in a fragment of a damaged component expelled at a low velocity
Class II
Medical Device Recall · April 15, 2024
CareFusion 303, Inc.
BD Pyxis(TM) Anesthesia Station 4000, REF: 338
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
Class II
Medical Device Recall · April 15, 2024
Stryker Orthopaedics
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software: TKA 2.0.it.1+TKA 1.0.1.it.1+
Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdown or a Mako System restart is not performed prior to switching between applications (i.e. TKA to THA), resulting in delay in treatment
Class II
Medical Device Recall · April 15, 2024
Stryker Orthopaedics
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software: TKA 2.0 + TKA 1.0.1 + THA 4.
Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdown or a Mako System restart is not performed prior to switching between applications (i.e. TKA to THA), resulting in delay in treatment
Class II
Medical Device Recall · April 15, 2024
CareFusion 303, Inc.
BD Pyxis" Anesthesia Station ES, REF: 327
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
Class II
Medical Device Recall · April 15, 2024
Stryker Orthopaedics
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1 Software: TKA 2.0.de.1+TKA 1.0.1.de.1+P
Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdown or a Mako System restart is not performed prior to switching between applications (i.e. TKA to THA), resulting in delay in treatment
Class II
Medical Device Recall · April 15, 2024
CareFusion 303, Inc.
BD Pyxis MedStation 4000 System, REF: 303, Medication Cabinet
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
Class II
Medical Device Recall · April 15, 2024
Stryker Orthopaedics
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software:TKA 2.0.fr.1+TKA 1.0.1.fr.1+P
Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdown or a Mako System restart is not performed prior to switching between applications (i.e. TKA to THA), resulting in delay in treatment
Class II
Medical Device Recall · April 15, 2024
Stryker Orthopaedics
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1 Software: TKA 2.0.es.1 + PKA 3.0.2.es.1
Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdown or a Mako System restart is not performed prior to switching between applications (i.e. TKA to THA), resulting in delay in treatment
Class II
Medical Device Recall · April 15, 2024
Stryker Orthopaedics
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software: TKA 2.0 + TKA 1.0.1 + THA 4.
Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdown or a Mako System restart is not performed prior to switching between applications (i.e. TKA to THA), resulting in delay in treatment
Class II
Medical Device Recall · April 15, 2024
CareFusion 303, Inc.
BD Pyxis MedStation 4000 7-Drawer Auxiliary Tower, REF: 306
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
Class II
Medical Device Recall · April 12, 2024
Medartis Inc.
APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation system.
Screw is 16mm long instead of 22mm long.
Class II
Medical Device Recall · April 11, 2024
FUJIFILM Healthcare Americas Corporation
Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24
AC adapters of Noblus can heat up, and cause smoke in the worst case, when an excessive mechanical stress is applied to the socket for power cable (frequent insertion/removal of the power cable).
Class II
Medical Device Recall · April 11, 2024
FUJIFILM Healthcare Americas Corporation
FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routin
Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, could result in patient injury
Class II
Medical Device Recall · April 11, 2024
Securitas Healthcare LLC
Arial mobile application, model numbers 54640, 54630, and 54630-SMA, that utilizes Apple iOS 17.4 and Apple iOS 17.5, a component of the Arial Emergency and Nurse Call System.
The Arial Mobile Application utilizing Apple iOS 17.4 and iOS 17.5 is frequently restarting causing the app to receive alerts for all pending alarm notifications and other events when the app restarts, experience difficulty in placing and maintaining staff-to-staff phone calls, and frequently appears offline while the app restarts.
Class II
Medical Device Recall · April 10, 2024
Preat Corp
9006767 Astra EV 4.8mm Milled Titanium Abutment Milled abutments are too be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.
Due to incorrect milled titanium abutment being packaged and labeled.
Class II
Medical Device Recall · April 10, 2024
LEICA BIOSYSTEMS NUSSLOCH GMBH
Leica HistoCore PEGASUS Tissue Processor, REF 14048858005.
Poorly processed and/or damaged biopsy tissue specimens on the device resulting from reagent levels exceeding the maximum fill level marks on reagent bottles or in the paraffin tanks.
Class II
Medical Device Recall · April 9, 2024
Baxter Healthcare Corporation
Spectrum IQ Infusion pump, Product Code 357009
There is a potential for cracks on the mount of the front panel of the device.
Class II
Medical Device Recall · April 9, 2024
QUIDELORTHO
VITROS Immunodiagnostic Products Free T3 Reagent Pack-IVD is for the quantitative measurement of free triiodothyronine (FT3) in human serum and plasma (EDTA or heparin). Product Code: 131 5589
T3 Reagent Packs used with Free T3 Calibrators may produce positively biased results for patient and quality control samples. The positive bias may cause erroneous patient results or a delay in testing that may impact patient management, clinical assessment, and the results of other thyroid function tests.
Class II
Medical Device Recall · April 9, 2024
Sophysa S.A.
The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pressure and temperature with tunneling (PSO-VTT) indicated for use
An increase in claims related to leakage of cerebrospinal fluid (CSF) from the proximal end of the catheter. In the event of a leak going undetected during implantation, it could pose an infectious risk to the patient. The cause of the leaks is indicated to be manufacturing error involving perforation of the inner channel of the catheter during stylet insertion.
Class II
Medical Device Recall · April 9, 2024
Sophysa S.A.
The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pressure with tunneling (PSO-VT) indicated for use in intraventricu
An increase in claims related to leakage of cerebrospinal fluid (CSF) from the proximal end of the catheter. In the event of a leak going undetected during implantation, it could pose an infectious risk to the patient. The cause of the leaks is indicated to be manufacturing error involving perforation of the inner channel of the catheter during stylet insertion.
Class II
Medical Device Recall · April 9, 2024
GE Medical Systems Information Technologies Inc
GE HealthCare CRITIKON ONE-CUF blood pressure cuffs, Model numbers: 1. ONE-A1-1B, ONE-CUF, SMALL ADULT, 1 TB BAYONET, 17 - 25 CM, 20/BOX; 2. ONE-A1-2A, ONE-CUF, SMALL ADULT, DINACLICK 80369-5, 1
Use of the blood pressure cuffs could result in inaccurate non-invasive blood pressure measurements.
Class II
Medical Device Recall · April 9, 2024
QUIDELORTHO
VITROS Immunodiagnostic Products Free T3 Calibrators-IVD are for use with Free T3 Reagent Pack for the quantitative measurement of free triiodothyronine (FT3) in human serum and plasma (EDTA or hepari
Free T3 Calibrators used with T3 Reagent Packs may produce positively biased results for patient and quality control samples. The positive bias may cause erroneous patient results or a delay in testing that may impact patient management, clinical assessment, and the results of other thyroid function tests.
Class II
Medical Device Recall · April 8, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline procedural kits labeled as: 1) FETAL SURGERY-LF, Pack Number CDS840214Q; 2) FETAL SURGERY CDS-LF, Pack Number CMPJ26754O
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Class II
Medical Device Recall · April 8, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline procedural kits labeled as: 1) ARTHROGRAM TRAY, Pack Number MNS11965A; 2) ARTHROGRAPH TRAY, Pack Number MNS12670A; 3) CIRCUMCISION TRAY, Pack Number CIT6860A; 4) CIRCUMCISION TRAY, Pa
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Class II
Medical Device Recall · April 8, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits labeled as: 1) CYSTO PACK, Pack Number DYNJ42742D; 2) CYSTO PACK, Pack Number DYNJ42799
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Class II
Medical Device Recall · April 8, 2024
MEDLINE INDUSTRIES, LP - Northfield
See RES description
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Class II
Medical Device Recall · April 8, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline convenience kits labeled as: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398281J ; 2) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AG; 3) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AI; 4)
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Class II
Medical Device Recall · April 8, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits, labeled as: 1) TRACH CDS-LF , Pack Number CDS983142B ; 2) MER TRACH CDS , Pack Number CDS984376B ; 3) Flexible LMA Pack with Syringe and Lube, Size 1, Pack Number DYN
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Class II
Medical Device Recall · April 8, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits labeled as: 1) KIT MANIFOLD CSTM-NORTHRIDGE, Pack Number 129736 ; 2) KIT LEFT HEART-VA MED, Pack Number 132701; 3) KIT MANIFOLD CSTM-RENAISSANC, Pack Number 134085 ;
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Class II
Medical Device Recall · April 8, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits labeled as: 1) EP DRAPE PACK-LF, Pack Number DYNJ0209716K ; 2) MERCY COMBINED PACK-LF, Pack Number DYNJ0233004D ; 3) E P DRAPE PACK-LF , Pack Number DYNJ0373061J ; 4)
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Class II
Medical Device Recall · April 8, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline procedure packs containing Shenli syringes, labeled as follows: 1) CVC INSERT BUNDLE 16CM, Pack Number ECVC3260; 2) VANTEX 7FR 3L 20CM CVC BUNDLE US, Pack Number ECVC8045
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Class II
Medical Device Recall · April 8, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits, labeled as: 1) TRACHEOTOMY TRAY, Pack Number DYNDA1894; 2) TRACHEOSTOMY, Pack Number DYNJ45495G ; 3) TRACH PACK, Pack Number DYNJ46518G ; 4) EH EMERGENCY TRACH TRAY
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Class II
Medical Device Recall · April 8, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline procedure kits labeled as: 1) CONTINUOUS BLOCK, Pack Number DYNJRA0960C; 2) COMBINED SPINAL AND EPIDURAL, Pack Number DYNJRA1268C; 3) WAL- UNIVERSAL BLOCK TRAY, Pack Number DYNJRA1638C;
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Class I
Medical Device Recall · April 8, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits labeled as: 1) PSP - VAMC LONG BEACH, Pack Number 146255; 2) INSERTION TRAY, Pack Number CVI5080; 3) INCISION & DRAINAGE TRAY, Pack Number DYNDA1063; 4) DRAINAGE ACCE
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Class II
Medical Device Recall · April 8, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits, labeled as: 1) TRACHEOTOMY TRAY, Pack Number DYNDA1894; 2) ULTRASOUND GUIDED PIV KIT, Pack Number MNS9580;
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Class II
Medical Device Recall · April 8, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits, labeled as: 1) NERVE BLOCK TRAY-LF, Pack Number DYNJRA0377B; 2) PERIPHERAL NERVE BLOCK, Pack Number PAIN0137
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Class II
Medical Device Recall · April 8, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline procedural kits labeled as: 1) LEEP PACK, Pack Number DYNJ40348G; 2) TRAB BUCKLE DSC, Pack Number DYNJ63036B
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Class II
Medical Device Recall · April 8, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits labeled as: 1) GB GENERAL ENDO , Pack Number CDS984155G ; 2) BAPTIST FLOYD ENDO GI KIT , Pack Number DYKE1455B; 3) ENDO KIT, Pack Number DYKE1487C; 4) BRONCH ENDO W/O
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Class II
Medical Device Recall · April 8, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits labeled as: 1) NHP BREAST BIOPSY PACK, Pack Number DYNJ17400B; 2) BREAST BIOPSY TRAY, Pack Number DYNJ32049A ; 3) BREAST BIOPSY PACK, Pack Number DYNJ44987G ; 4) BREA
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Class II
Medical Device Recall · April 8, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline procedural kits labeled as: CIRCUMCISION TRAY, Pack Number DYNDA2271
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Class II
Medical Device Recall · April 8, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits labeled as: HSG TRAY, Pack Number DYNDH1453
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Class II
Medical Device Recall · April 8, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits labeled as: 1) ADMIT KIT , Pack Number DYKA1225B; 2) BRANSON SUPPLEMENTAL PACK , Pack Number DYNDA3019; 3) L & D PACK-LF , Pack Number DYNJ16121O ; 4) FAMILY PLANNING
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Class II
Medical Device Recall · April 8, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits labeled as: 1) KIT GENERAL CLOSURE , Pack Number DYKMBNDL200A ; 2) KIT GENERAL CLOSURE , Pack Number DYKMBNDL200AH; 3) CUST CHEST TUBE INSERTION X , Pack Number DYNDA24
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Class II
Medical Device Recall · April 8, 2024
MEDLINE INDUSTRIES, LP - Northfield
Centurion procedure kits labeled as: 1) BONE MARROW TRAY, Pack Number SPEC0255; 2) CT/ULTRASOUND BIOPSY, Pack Number SPEC0262; 3) FINE LACERATION KIT, Pack Number SUT17215; 4) INFECTION DRIVE
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Class II
Medical Device Recall · April 8, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits labeled as: 1) GER ARTH BASIN PK RFID-LF , Pack Number DYNJ0100999K ; 2) PEDIATRIC MAJOR BASIN PACK-LF , Pack Number DYNJ0154061C ; 3) EYE BASIN PACK-LF , Pack Number DYNJ
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Class II
Medical Device Recall · April 8, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits labeled as: 1) INFECTION DRIVELINE MANAGEMENT KIT, Pack Number DM645; 2) PICU LINE TRAY, Pack Number DYNDC1960A; 3) ULTRASOUND GUIDE BREAST BIOPSY, Pack Number DYNDH131
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Class II
Medical Device Recall · April 8, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits, labeled as: aa1) BURN PACK-LF, Pack Number DYNJ0781678S ; 2) BURN PACK , Pack Number DYNJ0976092P ; 3) BURN PACK-LF, Pack Number DYNJ42829B ; 4) BURN PACK , Pack Nu
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Class II
Medical Device Recall · April 8, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits labeled as: 1) OR CLEAN UP KIT, Pack Number DYK1002355X3, 2) CLEANING & CUTTING, Pack Number DYNJ84657
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Class II
Medical Device Recall · April 8, 2024
MEDLINE INDUSTRIES, LP - Northfield
Centurion procedure kits labeled as: UMBILICAL VESSEL TRAY, Pack Number UVT1100
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Class II