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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

Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.

Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm.

AffectedProdisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.; Prodisc C SK U.S. IMPLANT...
RiskProduct labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK...
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

See RES for complete list. Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to...

AffectedSee RES for complete list. Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499; 2) BREAST-H...
RiskMedline has identified issues related to calibration of the equipment used to sterilize and package the devices. All...
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

VOCSN V+Pro package, REF: PRT-01198-000

Respiratory system intended to provide continuous/intermittent ventilator support, may not have been evaluated under all intended high-pressure conditions during production testing, so an oxygen leak condition could occur that may lead to reduced below inte...

AffectedVOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000
RiskRespiratory system intended to provide continuous/intermittent ventilator support, may not have been evaluated under...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use

BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide levels below specification.

AffectedBD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use; BD GasPak EZ Campy Pouch System. Catalo...
RiskBD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model Number U125

Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the advisory population is expanding to include all CRT-P and dual-chamber...

AffectedBoston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model Number U125; 2. VALI...
RiskUpdated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemaker...
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: CMP-01669 Software...

It was identified that certain devices were being operated outside the validated and FDA-cleared display configuration due to user modification of the manufacturer-installed settings. Modifications included disabling Barco Application Appearance Manager (AA...

AffectedBrand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number:...
RiskIt was identified that certain devices were being operated outside the validated and FDA-cleared display configuratio...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM. Part Number: 150450108.

The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

AffectedDepuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM. Part Number: 150450108.; Depuy Synthes, ATTUNE REVISION HIN...
RiskThe external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Heraeus, PALAMIX uno. Material Number: 66057893.

Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing process. Notification is to reduce the shelf life from 3 years to 1.5 years...

AffectedHeraeus, PALAMIX uno. Material Number: 66057893.; Heraeus, PALAMIX duo. Material Number: 66057897.
RiskBased on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

iLet Bionic Pancreas, REF: BB1001

insulin pump software versions 1.4.2, and 1.4.3 issue with Dexcom Continuous Glucose Monitoring (CGM) G7 sensor may result in delayed CGM reading then switch to non-CGM dosing, leading to only basal/requested meal doses provided, no correction doses/insulin...

AffectediLet Bionic Pancreas, REF: BB1001
Riskinsulin pump software versions 1.4.2, and 1.4.3 issue with Dexcom Continuous Glucose Monitoring (CGM) G7 sensor may r...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Medline medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. BLOOD CULTURE KIT, Medline Kit SKU DYNDH1520

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the discovery of a co...

AffectedMedline medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. BLOOD CULTURE KIT, Medlin...
RiskMedline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Medline Neuro Sponges, various dimensions, labeled as: 1. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.25" X 0.25", XR, 10/PK, Med...

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.

AffectedMedline Neuro Sponges, various dimensions, labeled as: 1. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.25" X 0...
RiskDuring an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Medtronic Sphere-9 Catheter, Model Number AFR-00001

Ventricular fibrillation (VF) occurred during radiofrequency (RF) therapy with the Medtronic Sphere-9 catheter in patients who have a Biotronik Implantable Cardioverter Defibrillator (ICD) or Biotronik Cardiac Resynchronization Therapy-Defibrillator (CRT-D)...

AffectedMedtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atria...
RiskVentricular fibrillation (VF) occurred during radiofrequency (RF) therapy with the Medtronic Sphere-9 catheter in pat...
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145.

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

AffectedPhilips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145.; Philips SmartPath t...
RiskThe potential for stiffness value errors when a specific range of image reconstruction parameters is used in combinat...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS

There is a possibility of reagent leakage from the specimen container.

AffectedVACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS
RiskThere is a possibility of reagent leakage from the specimen container.
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

WHILL Model C2, with software versions before HMI: 2.22 / MC: 1.13

Cyber vulnerability of BLE communication was found by CISA VDP program.

AffectedWHILL Model C2, with software versions before HMI: 2.22 / MC: 1.13; device is an indoor/outdoor battery-operated 2-wh...
RiskCyber vulnerability of BLE communication was found by CISA VDP program.
ActionNot available

Missing from associated official evidence: action.