January 8, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline custom medical procedure kits labeled as: 1) MEM MAXILLOFACIAL PACK-LF, REF DYNJ0660040R; 2) FREE FLAP PACK-
Hazard: Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
January 8, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline custom medical procedure kits labeled as: 1) PANENDOSCOPY-LF, REF DYNJ36728C; 2) ENDOSCOPIC SINUS PACK, REF
Hazard: Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
January 8, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline custom medical procedure kits labeled as: 1) ENDOSCOPIC SKULL BASE, REF DYNJ58648B; 2) ENDOSCOPIC SKULL BAS
Hazard: Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
January 8, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline custom medical procedure kits labeled as: 1) FREE FLAP BASIC SET-UP PK, REF DYNJ0991320J; 2) MVFF/FIBU #54-
Hazard: Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
January 8, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls See DocMan
Hazard: Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
January 8, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline custom medical procedure kits labeled as: 1) NASAL PACK, REF DYNJ67789A.
Hazard: Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
January 8, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline custom medical procedure kits labeled as: 1) UMC DR. BAKER SUPPLEMENT, REF DYNJ69476; 2) DIEP FLAP, REF DYN
Hazard: Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
January 8, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline custom medical procedure kits labeled as: 1) VP SHUNT CDS, REF CDS983470D; 2) 1/2X1/2 NEURO SPONGE PACK-LF,
Hazard: Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
January 8, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline custom medical procedure kits labeled as: 1) OPEN HEART CDS-LF, REFCDS840451M; 2) NEURO PACK, REFDYNJ41516M
Hazard: Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
January 8, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline custom medical procedure kits labeled as: 1) CATH LAB PACK-LF, REF DYNJ0382559M; 2) CRANI, REF DYNJ56001B;
Hazard: Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
January 8, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2
Hazard: Devices were identified as released after repair without full testing being performed, which includes flow testing.
January 8, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 35700BAX
Hazard: Devices were identified as released after repair without full testing being performed, which includes flow testing.
January 8, 2025Medical DevicesFDA
Medtronic Neuromodulation recalls SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900E CLINICIAN TABLET GLBL SMS
Hazard: Software issues were identified in application version 2.x.
January 8, 2025Medical DevicesFDA
Medtronic Neuromodulation recalls SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900D CLINICIAN TABLET GLOBAL w
Hazard: Software issues were identified in application version 2.x.
January 8, 2025Medical DevicesFDA
Medtronic Neuromodulation recalls SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900C CLINICIAN TABLET UK with
Hazard: Software issues were identified in application version 2.x.
January 8, 2025Medical DevicesFDA
Medtronic Neuromodulation recalls SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900B CLINICIAN TABLET EU -UK w
Hazard: Software issues were identified in application version 2.x.
January 8, 2025Medical DevicesFDA
Angiodynamics, Inc. recalls AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100
Hazard: Potential for procedural delays or interruptions during use of the Auryon Atherectomy System due to the Auryon Atherectomy System not advancing to the Activation (Ready) mode.
January 1, 2025Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls LINK MP Reconstruction System Neck Segment (with suture holes, standard, uncemented, L= 35 mm, CCD 126¿, Offset= 31 mm,
Hazard: Error on the main label and the patient label. The labels indicate a size XXL, this is a standard-size neck segment.. All further information on the labels is correct (Length, CCD and Offset).
January 1, 2025Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158;
Hazard: Siemens Healthcare Diagnostics is recalling two lots of their Dimension Vista¿ Total Magnesium (MG) Flex Reagent Cartridges (lots 24057BB and 24064BC) due to the potential for falsely low measurements of magnesium in plasma. Because the error is intermittent, existing quality control procedures may not recognize that a patients results are incorrect, and the results may be reported out
January 1, 2025Medical DevicesFDA
Encore Medical, LP recalls EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF: 342-14-703
Hazard: 5R 16MM knee tibial insert package may contain knee tibial insert 3R 14MM and vice versa, which may cause surgical delay to get a new product.
January 1, 2025Medical DevicesFDA
Moximed, Inc. recalls MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Implant Small, Right, REF: 2-1002.
Hazard: Knee implant may fracture due to a supplier-related issue with one component that has nonconforming geometry at the distal end of the absorber component that may result in a reduced wall thickness and microcracks, which may lead to new or worsening symptoms of discomfort, swelling / edema, pain or stiffness, which may necessitate removal of the device.
January 1, 2025Medical DevicesFDA
Encore Medical, LP recalls EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706
Hazard: Knee insert package may contain an acetabular system, which may cause surgical delay to get a new product.
January 1, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls RUMMELL, Medline Item No. ST006ST
Hazard: Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
January 1, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls ST IUD REMOVAL HOOK 10" (504090), Medline Item No. I68785
Hazard: Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
January 1, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls ST REPROCESSED BRUNS CURETTE #00 (BC00), Medline Item No. 67600K
Hazard: Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
January 1, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls STERILE MAGILL FORCEP (MAGF9), Medline Item No. 66790
Hazard: Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
January 1, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls ST OR MAYO HEGAR NEEDLEHOLDER 6"(OR2500), Medline Item No. 67870
Hazard: Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
January 1, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls O.R. SCISSORS, S/B, 5.5 STERILE, Medline Item No. DYND04000
Hazard: Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
January 1, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls STERILE STRT KELLY HEMOSTAT (SK8039S), Medline Item No. 66695
Hazard: Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
January 1, 2025Medical DevicesFDA
Abbott Medical recalls The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming
Hazard: Due to a programmer software anomaly, during finalizing of the leadless pacemaker system, a specific sequence of programmer actions combined with a loss of telemetry during a small window (<2 seconds) may cause the finalization step to fail. If this occurs, the Programmer displays a loss of telemetry detected window, and there is no pacing.