February 5, 2025Medical DevicesFDA
Karl Storz Endoscopy recalls KARL STORZ - ENDOSKOPE, REF: 27030KA, Cysto-Urethroscope, NON STERILE, CE
Hazard: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
February 5, 2025Medical DevicesFDA
Karl Storz Endoscopy recalls KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm, RxONLY, CE0123
Hazard: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
February 5, 2025Medical DevicesFDA
CareFusion 303, Inc. recalls BD Pyxis MedStation ES AUX Tower REF 343 BD Pyxis " MedStation 4000 AUX Tower REF 314 The BD Pyxis" MedStation ES
Hazard: Due to an increase in complaints of door latch assembly failures that may cause the doors to be left in an open state potentially causing inventory discrepancies, a delay in access to medication and/or diversion of medication.
February 5, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE ARTERIAL LINE PACK, REF DYNJ65208B, medical convenience kit containing Infusion Catheter with Antimicrobial Hep
Hazard: Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were either distributed or manufactured into medical convenience kits and distributed.
February 5, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls CENTURION Infusion Catheter, 7F, 17cm (DO), Reorder MIC17F7; Infusion Catheter with Antimicrobial Heparin Coating.
Hazard: Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were either distributed or manufactured into medical convenience kits and distributed.
February 5, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline procedure kits labeled as: 1) CENTRAL LINE DRESSING KIT, Reorder number DYNDC3189; dressing change tray
Hazard: Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops, and SOFT TOUCH II Surgical Masks which were subsequently recalled for not meeting the bioburden testing requirements of EN 14683.
February 5, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline procedure kits labeled as: 1) SHORT TERM INFUSAPORT ACCESS KIT, Reorder number DYNDC3188; surgery tray
Hazard: Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops, and SOFT TOUCH II Surgical Masks which were subsequently recalled for not meeting the bioburden testing requirements of EN 14683.
February 5, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline procedure kits labeled as: 1) Port Access Kit, Reorder number CVI5130; 2) VANTEX 7FR 3L 20CM CVC STOCK+ BUN
Hazard: Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops, and SOFT TOUCH II Surgical Masks which were subsequently recalled for not meeting the bioburden testing requirements of EN 14683.
February 5, 2025Medical DevicesFDA
Zimmer, Inc. recalls NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Yellow/E,F - Height 10 mm, Item Number 00-5994-032-10
Hazard: It was identified internally that two commingle events occurred where the metal support post within the polyethylene articular surface was assembled incorrectly for three units within the scope.
February 5, 2025Medical DevicesFDA
Zimmer, Inc. recalls NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D - Height 14 mm, Item Number 00-5994-022-14
Hazard: It was identified internally that two commingle events occurred where the metal support post within the polyethylene articular surface was assembled incorrectly for three units within the scope.
February 5, 2025Medical DevicesFDA
Boston Scientific Corporation recalls HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553570
Hazard: Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
February 5, 2025Medical DevicesFDA
Boston Scientific Corporation recalls HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553560
Hazard: Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
February 5, 2025Medical DevicesFDA
Boston Scientific Corporation recalls HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553550
Hazard: Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
February 5, 2025Medical DevicesFDA
Boston Scientific Corporation recalls HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553540
Hazard: Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
February 5, 2025Medical DevicesFDA
Boston Scientific Corporation recalls HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553530
Hazard: Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
February 5, 2025Medical DevicesFDA
Boston Scientific Corporation recalls HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553520
Hazard: Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
February 5, 2025Medical DevicesFDA
Boston Scientific Corporation recalls AXIOS Stent and Delivery System 15mmx10mm UPN: M00553750
Hazard: Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
February 5, 2025Medical DevicesFDA
Boston Scientific Corporation recalls AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740
Hazard: Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
February 5, 2025Medical DevicesFDA
Boston Scientific Corporation recalls AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553690
Hazard: Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
February 5, 2025Medical DevicesFDA
Boston Scientific Corporation recalls AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553680
Hazard: Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
February 5, 2025Medical DevicesFDA
Boston Scientific Corporation recalls AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553670
Hazard: Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
February 5, 2025Medical DevicesFDA
Boston Scientific Corporation recalls AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553660
Hazard: Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
February 5, 2025Medical DevicesFDA
Boston Scientific Corporation recalls AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553650
Hazard: Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
February 5, 2025Medical DevicesFDA
Boston Scientific Corporation recalls AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553640
Hazard: Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
February 5, 2025Medical DevicesFDA
Accuray Incorporated recalls CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be labeled as CyberKnife M6TM or VSI TM R
Hazard: Snap rings may become partially or completed detached from the shafts within the internal mechanism. Uncontrolled rotation may occur on the left and right roll axes when the rings are removed or damaged.
February 5, 2025Medical DevicesFDA
Medtronic Navigation, Inc. recalls Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 Th
Hazard: Due to an increase in complaint that the percutaneous reference pin would not fit into the patient reference frame or percutaneous pin adapter.
February 5, 2025Medical DevicesFDA
B. Braun Medical, Inc. recalls Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of analgesic/anesthetic agent to intrathecal
Hazard: Incorrect catheter connector within the kit resulting in inability to provide a secure connection to the epidural catheter. The incorrect catheter connector is smaller than the required catheter connector and therefore is unable to be used to administer medication.
February 5, 2025Medical DevicesFDA
Instrumentation Laboratory recalls HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic
Hazard: Control indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range.
February 5, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline General Surgery Tray kits: 1) ARTERIAL LINE TRAY, Item Number ART600; 2) A LINE TRAY, Item Number ART690
Hazard: The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub.
February 5, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline General Surgery Tray Kits: 1) ARTERIAL LINE INSERTION KIT, Item Number ART1185B; 2) ARTERIAL LINE BUNDLE, I
Hazard: The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub.