Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
ðĨ
Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
LOCAL PACK. Sterile Procedural Tray.
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Sterile Procedural Trays, labeled as the following: a. RHINOPLASTY PACK b. OSC OTOLOGY PACK-LF c. RHYZOTOMY
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Class I - Dangerous
Firm identified that user may be unable to adjust the length of the Smart Correction Dual Joint Express Struts due to the collar release pin backing out. This may lead to a delay in correction.
FEMORAL ARTERY PACK-LF. Sterile Procedural Tray
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Class I - Dangerous
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Sterile Procedural Trays, labeled as the following: a. UNIVERSAL PLASTIC b. KNEE ARTHROSCOPY PACK
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
The Covera Vascular Covered Stent is a flexible, self-expanding endoprothesis comprised of ePTFE encapsulating a nitinol stent framework. The inner lumen of the covered stent is carbon impregnated.
Bard Peripheral Vascular
Class I - Dangerous
An increase in the reported complaint rate for inability to deploy was identified and related to poor slide block bonding.
FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 47147
Owens & Minor Distribution
Class I - Dangerous
Face masks were placed into the incorrect dispenser boxes. The face masks come with ear loops, but the dispenser is incorrectly labeled as face masks with ties instead of ear loops.
Sterile Procedural Trays, labeled as the following: a. MAJOR CDS-LF b. BURN PACK-LF c. BURN PACK d. SMALL BURN
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Sterile Procedural Trays, labeled as the following: MINOR BASIC PACK-LF
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Class I - Dangerous
Due to an incorrect security key, customers were unable to connect to remote monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremity procedures.
GE Nuclear Medicine 600/800 series systems, specifically: a) BRIVO B615 3/8 inch DHP BJG NR, b) BRIVO 615 3/8 inch, c) BRIVO B615 3/8 inch DHP BJG NR, d) B615 with new rotor, e) BRIVO B615 3/8 inch BJG, f) BRIVO B615 3/8 inch DHP BJG NR, g) B615 with new rotor; Emission Computed Tomography System
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Class I - Dangerous
A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.
Class I - Dangerous
Overly aggressive tension on the pull suture, while passing the medial button through a bone/soft tissue tunnel across the fibula and tibia, can exceed its strength causing it to break.
Sterile Procedural Trays, labeled as the following: a. ORAL SURGERY PACK-LF b. EXTRACTION PACK c. ORAL SURGERY PACK d. DENTAL MINOR PACK e. ORAL
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.
Sterile Procedural Trays, labeled as the following: a. WOUND CLOSURE TRAY b. WOUND PACK
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
GE Nuclear Medicine 600/800 series systems, specifically: a) 870 CZT O540+ Gantry 7.25mm, b) D670 CZT Gantry 7.25mm, c) DISCOV NM/CT 870 CZT, d) Discovery NMCT 670 CZT O540+, e) NM/CT 870 CZT CYBER DEFENCE, f) NM/CT 870 CZT O540, g) NM/CT 870 CZT WSO, h) NM/CT 870 CZT, i) NM/CT 870 CZT O540+ 7.25MM; Emission Computed Tomography System
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Class I - Dangerous
A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.
Sterile Procedural Trays, labeled as the following: GENERAL ENDOSCOPY
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.