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Patient-Relevant Medical Devices recalls

Devices a patient or caregiver can identify as used, worn, implanted, or supplied for their care.

Limited official informationPatient-Relevant Medical Devices

Medline Convenience Kits: 1) DYNJ905503F, Model Number: CV ANESTHESIA - ROOM SET UP

The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the...

AffectedMedline Convenience Kits: 1) DYNJ905503F, Model Number: CV ANESTHESIA - ROOM SET UP; 2) DYNJ905503G, Model Number: CV...
RiskThe Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupi...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Multi-Snare Set: 5 mm x 125 cm, REF: 147305

A snare catheter including luer lock, indicated for removal or manipulation of a foreign body in the vascular system, failed to meet the biocompatibility requirements for in-vitro-cytotoxicity, which if in contact with a patient's vasculature could result i...

AffectedMulti-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310
RiskA snare catheter including luer lock, indicated for removal or manipulation of a foreign body in the vascular system,...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Octopus Evolution AS Tissue Stabilizer, Model TS2500

During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended de...

AffectedOctopus Evolution AS Tissue Stabilizer, Model TS2500; Octopus 4 Tissue Stabilizer, Model 29400; plus 1 additional off...
RiskDuring the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly p...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241

Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

AffectedOff-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241; Off-...
RiskFive complaints have been received identifying issues where the plastic guides were catching during reaming, leading...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A

Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.

AffectedPhilips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A; Philips Avalon Fetal Monitor, FM 30 Part numberM...
RiskMonitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descriptions: TELE Monitor 5500, 1.4 Ghz, ECG...

Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device configuration and the equipment label, resulting in a failure to reconnect to the PIC iX central monitoring system.

AffectedPhilips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descriptions: TELE Monito...
RiskPotential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device configuration and the...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

AffectedSurgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, trephines & accessories (simple, powered);...
RiskPotential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.

Software anomaly that causes a false display of error code 5018.

AffectedThuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.
RiskSoftware anomaly that causes a false display of error code 5018.
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

TMJ Bilateral Implants, REF: CHG020

Custom temporomandibular joint implant may have contained incorrect patient-specific components that led to a poor fit of the implant, leading to a right-sided open bite.

AffectedTMJ Bilateral Implants, REF: CHG020
RiskCustom temporomandibular joint implant may have contained incorrect patient-specific components that led to a poor fi...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

VOCSN+Pro package, REF: PRT-00853-000

Respiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up battery supporting backup alarm function, which may result in the backup alarm not activating during loss of primary power and absence/depletion of...

AffectedVOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001
RiskRespiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up battery...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code: 00382903949106 BD Connecta" Stopcocks are used to administer fluids or medication t...

Due to stopcock issues when using the plastic luer-lok syringe, the connection at the Port C may over thread or continue to spin rather than tightening securely. This behavior has led some clinical users to perceive the connection as unstable.

AffectedBD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code: 00382903949106 BD Connecta" Stopcocks are used to administer fl...
RiskDue to stopcock issues when using the plastic luer-lok syringe, the connection at the Port C may over thread or conti...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead Model/Catalog Number: 4063 Product Description: The Insp...

Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a product past its Use By Date may result in unplanned or premature revision surgery.

AffectedBrand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead Model/Catalog Number: 4063 Product D...
RiskProducts are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of ma...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

ConMed AirSeal 12mm Access Port and Obturator with Blunt Tip, 100mm Length. Catalog Number: iASB12-100. 6 units per pack. Disposable Endo...

Potential for overpressure alerts.

AffectedConMed AirSeal 12mm Access Port and Obturator with Blunt Tip, 100mm Length. Catalog Number: iASB12-100. 6 units per p...
RiskPotential for overpressure alerts.
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Description/REF: PI JACC KIT: 2L 5.5 FR X 15 CM CG+/ASK-41552-LTAC

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable pro...

AffectedDescription/REF: PI JACC KIT: 2L 5.5 FR X 15 CM CG+/ASK-41552-LTAC; PI JACC KIT: 3L 6 FR X 20 CM CG+/ASK-42063-LTAC;...
RiskLidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets....
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500

GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during transport, one or more of the fasteners that secure the soffit can disengage. I...

AffectedGiraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500; Giraffe OmniBed, a combi...
RiskGE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Giraffe Stand-alone Infant Resuscitation System

Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient.

AffectedGiraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator (resuscitator) Product identifiers: 208...
RiskBlender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen...
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

HarmonyAIR A-Series Surgical Lighting System

The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.

AffectedHarmonyAIR A-Series Surgical Lighting System; ALYON Surgical Lighting System
RiskThe the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.

Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support.

AffectedImpella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.
RiskExposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases,...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Medline convenience kits: CMH CENTRAL LINE DRESSING CHANGE KIT EBSI1705A CVC/PICC/MIDLINE DRESSING CHANGE KIT EBSI1057A DIALYSIS DRESSING...

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

AffectedMedline convenience kits: CMH CENTRAL LINE DRESSING CHANGE KIT EBSI1705A CVC/PICC/MIDLINE DRESSING CHANGE KIT EBSI105...
RiskKits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuati...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

MEDLINE Medical Procedure Kits labeled as: 1) BASIC HEART PACK, Medline Kit/SKU DYNJ67331B

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from th...

AffectedMEDLINE Medical Procedure Kits labeled as: 1) BASIC HEART PACK, Medline Kit/SKU DYNJ67331B; 2) CARDIAC SURGERY, Medli...
RiskDuring an internal review, Medline identified representative samples did not meet applicable performance specificatio...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Medtronic O-arm O2 Imaging System. Model Number: BI70002000.

Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.

AffectedMedtronic O-arm O2 Imaging System. Model Number: BI70002000.
RiskPotential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Mito Red Light, Super Mobile

The near-infrared therapy device contains a lithium-ion battery that may malfunction, causing it to catch fire or burst into flames.

AffectedMito Red Light, Super Mobile
RiskThe near-infrared therapy device contains a lithium-ion battery that may malfunction, causing it to catch fire or bur...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Product Description: The STAAR ICL Calculation Software is de...

Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses.

AffectedProduct Name: STAAR ICL Calculation Software Software Version: Version 8.00 Product Description: The STAAR ICL Calcul...
RiskDue to a software coding issues for calculating the implant orientation diagram printout for the implantation for tor...
ActionNot available

Missing from associated official evidence: action, consumer scope.