Medical Device Recalls
RSS ↗8,689 medical device recalls from federal enforcement feeds.
Showing 4,301–4,350 of 8,689
- Class II
Medical Device Recall · March 11, 2025
Siemens Healthcare Diagnostics, Inc.
Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223.Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result.
- Class I
Medical Device Recall · March 11, 2025
BD 4 Fr Single-Lumen PowerPICC Catheters, REF: 3174155, CK000540, 3174118, CK000483, 3174335, 3174355, CK000196, 9174118, CK000955, 3174135, CK000617, CK000839, 3194355, 6174118, 3194135, 3194335, 217Catheters 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 increased material fatigue leaks, which could lead to infiltration, extravasation, discomfort, phlebitis, bleeding, air embolism, foreign body embolism, infection and interruption to therapy.
- Class II
Medical Device Recall · March 11, 2025
BD PYXIS MEDBANK (Name, REF): MEDPASS MODULE, 139088-01; MINI 1FH-1FM, 169-137; MINI 1HH-1FH-1HM, 169-101; MINI 1HH-1HM-1FM, 169-102; MINI 2FH, 138902-01; MINI 2FH, 169-104; MINI 2FM, 169-105;Users trying to restock a single bin location of an automated dispensing cabinet, during pocket exchange restocking workflow, may experience a software issue that results in 2 destock transactions and 2 stock transactions, which results in doubling the bin quantity, which may result in a delay in access to desired medications and/or supplies, which may lead to temporary body function impairment.
- Class II
Medical Device Recall · March 11, 2025
BD Pyxis MedBank CUBIE Replenishment Station Product / Material ID BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P / 155141-01 BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P / 155140-01 BD PYXIS MEDBANK TWR MN CR-Due to a software issue, when attempting to restock the automated dispensing cabinet, user have received the banner message "Stocking window has passed, or item has been removed from purchase order. Please contact Pharmacy for assistance". When this occurs, the medication cannot be restocked and can potentially lead to delays in accessing medication for patients.
- Class II
Medical Device Recall · March 10, 2025
Philips DXR System, DuraDiagnost Rel. 4. Stationary X-Ray System.Potential for collimator to fall as a result of incorrect installation.
- Class II
Medical Device Recall · March 10, 2025
NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, REF: NIM4CM01RF; PATIENT INTERFACE NIM4CPB1 NIM 4.0, REF: NIM4CPB1; PATIENNerve Monitoring System with certain software versions has potential for increased stimulus artifact, which may require troubleshooting, and may lead to procedure delay, extubation, and medical intervention.
- Class II
Medical Device Recall · March 10, 2025
Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System.Potential for collimator to fall as a result of incorrect installation.
- Class II
Medical Device Recall · March 10, 2025
Maquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of the Vasoview Hemopro EVH System (HemoPro 2).Incorrect resistor utilized in the VH-3010 Power Supply, which may cause the jaws of the HemoPro 2 to not adequately heat up.
- Class II
Medical Device Recall · March 8, 2025
TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002;The devices are missing the laser marked depth markings.
- Class II
Medical Device Recall · March 7, 2025
ETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MHIdentified curing issues with the silicone during the needles manufacturing process.
- Class II
Medical Device Recall · March 7, 2025
PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRMIdentified curing issues with the silicone during the needles manufacturing process.
- Class II
Medical Device Recall · March 7, 2025
PDSII¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1Identified curing issues with the silicone during the needles manufacturing process.
- Class II
Medical Device Recall · March 7, 2025
PDS¿PLUS¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1¿MPIdentified curing issues with the silicone during the needles manufacturing process.
- Class II
Medical Device Recall · March 6, 2025
Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and factor assays.The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.
- Class II
Medical Device Recall · March 6, 2025
Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage prothrombin time test and factor assays.The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.
- Class II
Medical Device Recall · March 6, 2025
Venue Fit Models: R3 (Model Number H45303VFSC, H45303VFSW), R4 (Model Number H45314VFS, H45314VFSW), Venue Fit R5 system (Model Numbers H45335VFS, H45335VFSW), R3 Surgery for China, R3 PeriOP for ChinThe battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.
- Class II
Medical Device Recall · March 6, 2025
Venue Go Models: R2 (Model Number H45181VG), R3 (Model Number H45193VG), R4 (Model Number H45114VG), R5 (Model Numbers H45135VG, H45135VGW), R3 Surgery for China (Model Number H45113VGSU), R3 PeriOP fThe battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.
- Class II
Medical Device Recall · March 5, 2025
stryker HoloBlueprint Application, Catalog Number MRUE001; Total Shoulder ArthroplastyStryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.
- Class II
Medical Device Recall · March 5, 2025
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE ReNewal ENT Coblator II PROcise mAx,W/ Integrated Cable Suction & Saline (Blue), Item Number REF EICA88980RMedline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.
- Class II
Medical Device Recall · March 5, 2025
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE ReNewal Coblator II ENT Evac 70 Xtra HP,w/Integrated Cable (Blue/Grey), Number REF EICA58740RMedline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.
- Class II
Medical Device Recall · March 5, 2025
stryker Blueprint Mixed Reality Glenoid Box Lid, Catalog Number MRUE205, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder ArthroplastyStryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.
- Class II
Medical Device Recall · March 5, 2025
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE ReNewal Coblator II Evac 70 Xtra Plasma Wand,w/Integrated Saline Line & Integrated Cable, Item Number REF EICA58720RMedline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.
- Class II
Medical Device Recall · March 5, 2025
stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder ArthroplastyStryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.
- Class II
Medical Device Recall · March 5, 2025
stryker Blueprint Mixed Reality Instrument Check Block, Catalog Number MRUE203, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder ArthroplastyStryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.
- Class II
Medical Device Recall · March 5, 2025
stryker Blueprint Mixed Reality Glenoid Digitizer, Catalog Number MRUE201, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder ArthroplastyStryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.
- Class II
Medical Device Recall · March 5, 2025
stryker Blueprint Mixed Reality Box Base, Catalog Number MRUE204, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder ArthroplastyStryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.
- Class II
Medical Device Recall · March 5, 2025
HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified.
- Class II
Medical Device Recall · March 5, 2025
stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide PPSU + Stainless Steel, Catalog Number MRUE200, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total ShoulStryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.
- Class II
Medical Device Recall · March 5, 2025
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE ReNewal ENT Coblator II PROcise XP Wand,w/Integrated Cable Suction & Saline (Blue), Item Number REF EICA88720RMedline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.
- Class II
Medical Device Recall · March 5, 2025
stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder ArthroplastyStryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.
- Class II
Medical Device Recall · March 5, 2025
stryker Blueprint Mixed Reality Depth Stop Pin, Catalog Number MRUE206; Total Shoulder ArthroplastyStryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.
- Class II
Medical Device Recall · March 4, 2025
Abbott Diagnostics Scarborough, Inc.
Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Description: Respiratory virus panel nucleic acid assay system Component: Nothe impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
- Class II
Medical Device Recall · March 4, 2025
Abbott Diagnostics Scarborough, Inc.
Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Description: Respiratory virus panel nucleic acid assay system Component: NoThe impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
- Class II
Medical Device Recall · March 4, 2025
Abbott Diagnostics Scarborough, Inc.
Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number: 427-000 Software Version: N/A Product Description: Influenza A And Influenza B Multiplex Nucleic Athe impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
- Class I
Medical Device Recall · March 4, 2025
Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT Platform Model/Catalog Number: Model 200 (Catalog Number: 8700-001070-1) Software Version: Version 2.0.1 Product DescriptAutoPulse NXT Resuscitation System may not provide adequate chest compressions or may stop compressions due to code FC1060.
- Class II
Medical Device Recall · March 4, 2025
Cordis, REF: C09060ML, Smart Control Vascular Stent System ILIAC, 9mm X 60mm 6F, SterileEO, Rx Onlyproduct mix-up; Vascular stent labeled as one size but contains a different size.
- Class II
Medical Device Recall · March 4, 2025
InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNAInsulin pens may have been incorrectly assembled therefore users could experience the following: either the insulin cartridge will not fit into the cartridge holder; or the cartridge holder may be difficult to remove from the insulin pen. If the issue is present, and if the user does not have backup insulin they may experience temporary hyperglycemia.
- Class II
Medical Device Recall · March 4, 2025
Abbott Diagnostics Scarborough, Inc.
Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-000 Software Version: N/A Product Description: Simple Point-Of-Care Device To Detect Sar-Cov-2 NucleThe impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
- Class II
Medical Device Recall · March 4, 2025
Abbott Diagnostics Scarborough, Inc.
Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number: 427-000 Software Version: N/A Product Description: Influenza A And Influenza B Multiplex Nucleic AThe impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
- Class II
Medical Device Recall · March 4, 2025
Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Onlyproduct mix-up; Vascular stent labeled as one size but contains a different size.
- Class II
Medical Device Recall · March 4, 2025
Abbott Diagnostics Scarborough, Inc.
Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-000 Software Version: N/A Product Description: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nuclethe impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
- Class II
Medical Device Recall · March 4, 2025
Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis Pro (Model 977118) neurostimulatorsThere is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific intraoperative programming sequence is used.
- Class II
Medical Device Recall · March 3, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, Model Number: DYNJ27333FThere is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
- Class II
Medical Device Recall · March 3, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits used for various procedures: 1) ANGIOGRAPHY DRAPE PACK, Model Number: HCP075G; 2) ENSEMBLE CORONAROGRAPHIE-LF, Model Number: DYNJ64354A; 3) RADIOL ANGIO PACK-LF, Model NuThere is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
- Class II
Medical Device Recall · March 3, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits used for various procedures: 1) BASIC CATARACT, Model Number: DYNJ41097A; 2) PK EYE, Model Number: DYNJ60631B; 3) CATARACT PACK, Model Number: DYNJ80316A; 4) BASIC EYEThere is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
- Class II
Medical Device Recall · March 3, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits used for various procedures: 1) STANDARD D&C, Model Number: DYNJ69733; 2) NHS - LAP BOWEL GNG, Model Number: DYNJ39904A; 3) LAPAROSCOPY GYN SURGERY PA, Model Number: DYNJThere is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
- Class II
Medical Device Recall · March 3, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits used for various procedures: 1) INTUBATION TRAY, Model Number: MNS10395;There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
- Class II
Medical Device Recall · March 3, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits used for various procedures: 1) NEURO PACK WRO-LF, Model Number: DYNJ41856C; 2) STIM IMPLANT PACK, Model Number: DYNJ53032C; 3) WMC VP SHUNT PACK-LF, Model Number: DYNJ50There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
- Class II
Medical Device Recall · March 3, 2025
Terumo Cardiovascular Systems Corporation
Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754During some clinical cases, it has been observed that the SO2 value may periodically appear as dashes on the Touchscreen Display indicating unavailable data. In these cases, a yellow low-limit alarm will also be triggered to the user, due to the dashed-out value.
- Class II
Medical Device Recall · March 3, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits used for various procedures: 1) SKIN LESION SET, Model Number: MNS6270There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.