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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

The intended use is to be paired with a weapon for aiming purposes.

Wilcox is notifying all customers who have purchased a product from the BOSS Xe family that a software enhancement to increase safety has been released and all units should be returned to implement this change.

AffectedThe intended use is to be paired with a weapon for aiming purposes.
RiskWilcox is notifying all customers who have purchased a product from the BOSS Xe family that a software enhancement to...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Ventriculostomy Kit, REF: 46154

Ventriculostomy devices, used during ventriculostomy procedures to gain access to the ventricular system, may exhibit endotoxin levels that exceed the acceptable limit for devices that come into contact with cerebrospinal fluid; endotoxin exposure can cause...

AffectedVentriculostomy Kit, REF: 46154
RiskVentriculostomy devices, used during ventriculostomy procedures to gain access to the ventricular system, may exhibit...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product Code 0052-3046. hear...

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in ever...

AffectedABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product...
RiskA potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. hear...

Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.

AffectedAbiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F...
RiskDue to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm,...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Brand Name: Rio" II Product Name: Rio" II Nasal Pillows Interface Model/Catalog Number: RII1001 (Small), RII1002 (Medium), RII1003 (Large...

Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).

AffectedBrand Name: Rio" II Product Name: Rio" II Nasal Pillows Interface Model/Catalog Number: RII1001 (Small), RII1002 (Med...
RiskPackaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI...
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15

Robotic-assisted surgical system arm drapes may detach from the instrument arm due to an issue involving the drape rings located at the top of the product, which may expose a section of instrument arm, which may result in procedure delay or conversion to an...

Affectedda Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15
RiskRobotic-assisted surgical system arm drapes may detach from the instrument arm due to an issue involving the drape ri...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

General Biospy Tray, REF: GUTS1000

Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.

AffectedGeneral Biospy Tray, REF: GUTS1000; Arterial Line Kit 20ga x 6, REF: 400115A; plus 4 additional official variants lis...
RiskKits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meet...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403

In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.

AffectedICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; infusion pump; ICU...
RiskIn a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen...
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK DYNJT6267

Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of product include clinically insignificant extension of surgery to find another readi...

AffectedMedline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK DYNJT6267; Medline Kits containing Zi...
RiskKits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present r...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115

Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.

AffectedMedtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannula; Medtr...
RiskMedtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.

Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.

AffectedOlympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.; Olympus Toomey...
RiskSome sterilization parameters included in the IFU may not consistently render the devices adequately sterile and ther...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Optima XR200amx, Mobile Digital-Ready Radiographic System

GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpo...

AffectedOptima XR200amx, Mobile Digital-Ready Radiographic System; Optima XR220amx, Mobile Digital-Ready Radiographic System;...
RiskGE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement com...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device

Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111

AffectedOrthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation dev...
RiskUnilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Papablic Replacement Brush Heads. Model Number: PAPA317AA.

Potential for brush heads to break.

AffectedPapablic Replacement Brush Heads. Model Number: PAPA317AA.; Papablic Replacement Brush Heads. Model Number: Papablic18B
RiskPotential for brush heads to break.
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Photera 600 3-D, phototherapy device

Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).

AffectedPhotera 600 3-D, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders; Photera 400, phototherapy device;...
RiskCalibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Rapid Refill Continuous Injection System, UPN M00566001

Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifold, resulting in loose connection or complete disconnection. May lead to difficulty connecting sy...

AffectedRapid Refill Continuous Injection System, UPN M00566001
RiskDevices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh...

The Test cup lot F level 1 low-quality control results values for the device were lower than expected on the Automated Immunoassay Analyzer (AIA) which could cause falsely elevated or falsely low total testosterone results. Such erroneous test results may l...

AffectedST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human seru...
RiskThe Test cup lot F level 1 low-quality control results values for the device were lower than expected on the Automate...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000

Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma sterilization run (Run ID 1183-28782A) performed by STERIS at its Whippany, NJ facility between March 31 and Apr...

AffectedThe Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000; UDI 00607567700406) is a sterile, single-u...
RiskGetinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification steril...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions. 1. 5008X HD Pre-Flush Standard Blood Tubing...

Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem.

Affected5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions. 1. 5008X HD Pre-Flush S...
RiskPotential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the su...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R

Surgical dressing manufactured out of specification (greater thickness).

AffectedAquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R
RiskSurgical dressing manufactured out of specification (greater thickness).
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.

The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which could cause falsely depressed or falsely elevated HbA1c patient results.

AffectedAtellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.
RiskThe potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 342-19-703 Product Description: Enovis kn...

Due to packaging discrepancy with incorrect product size mixed up.

AffectedBrand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 342-19-703 Product De...
RiskDue to packaging discrepancy with incorrect product size mixed up.
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote Afterloading Applicator Product Description: The Fl...

Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.

AffectedBrand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote Afterloading Applicator Product...
RiskDue to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Catalog Number: V-SS-1020 Software Version: Pratchet...

Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.

AffectedBrand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Catalog Number: V-SS-1020 Softwa...
RiskSecure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.
ActionNot available

Missing from associated official evidence: action, consumer scope.