Medical Devices Recalls
Defective surgical instruments, diagnostic equipment, and health device recalls.
Atellica CH Urine Albumin (UAlb). Material Number: 11537225
Falsely depressed UAlb patient results may occur. Affected samples with any urine albumin concentration above the UAlb measuring interval >40.0 mg/dL may report values between 6.2 mg/dL and 40.0 mg/dL.
Impella RP with SmartAssist. Product Code: 0046-0035.
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Impella RP. Product Code: 0046-0011.
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: ...
Under certain workflows, patient information shown in the viewer may not match the images displayed on Centricity Universal Viewer Zero Footprint Client (ZFP) with versions ZFP v6.0: SP11.6, SP11.6.0.1 and SP11.6.1 on systems with Patient Timeline installed,
Impella RP Flex with SmartAssist. Product Code: 1000323.
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Catal...
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Nam...
Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consistent with electromagnetic compatibility (EMC) standards and may decrease the overall reliability of the system and result in delay of treatment. It was discovered that additional serial numbers of ShockPulse generators may also have the mis-wired component. As a result, this is expanding the action to the additional impacted devices.
Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S...
The potential of out-of-range results and an underestimation of the free protein S level in normal patient plasmas. The defect only affects normal-range values.
Olympus Inner Sheath 21 Fr. Model No. A2660T. for endoscopic diagnosis and trea...
Complaints of the ceramic tip of the resection sheath breaking have been received.
Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatment i...
Complaints of the ceramic tip of the resection sheath breaking have been received.
Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR
Software anomaly in the patient positioning system may result in positional discrepancy.
Campy CVA Medium 100/PK, R01272
Customer complaints report low to no recovery of Campylobacter Jejuni ATCC 33291 on identified lot of medium.
Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;
Product being removed due to incompatibility when used in conjunction with a GreenLight Laser for BPH therapy which could damage the tip of the device.
Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic applica...
Complaints of the ceramic tip of the resection sheath breaking have been received.
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERA...
Knee and Humeral socket implants contain incorrect labeling.
Olympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gynecol...
Complaints of the ceramic tip of the resection sheath breaking have been received.
Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR
Software anomaly in the patient positioning system may result in positional discrepancy.
Olympus Inner Sheath, Long; Model No. WA22017T. Inner sheath for urological and...
Complaints of the ceramic tip of the resection sheath breaking have been received.
Medline Convenience Kits: 1) NAIL KIT, Model Number: POD14214
Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.
Olympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for urolog...
Complaints of the ceramic tip of the resection sheath breaking have been received.
PIE Trolley System Model: 2005
Lack of 510K clearance
Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU ...
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
Convenience kits containing Tego Connectors: Medline DIALYSIS DRESSING CHANGE...
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
Medline Kits containing Tego Connectors: Medline IR Pack, SKU DYNJ67205C Medli...
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.