Medical devices recalls
Implants, monitors, test kits and hospital equipment corrected or removed from the market.
-
Class II · 3 months ago
Freudenberg Medical, LLC Blom-Singer Classic Indwelling Voice Prosthesis recall: Incorrect labeling- The labeled box for the Large Esophageal Flange contains
Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the…
-
Class II · 3 months ago
Freudenberg Medical, LLC Blom-Singer Classic Indwelling Voice Prosthesis recall: Incorrect labeling- The labeled box for the Large Esophageal Flange contains
Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the…
-
Class II · 3 months ago
Beckman Coulter Inc. REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit recall: Analyzers contain incorrect algorithms which may affect antimicrobial
Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."
-
Class II · 3 months ago
GE Medical Systems Information Technologies Inc GE Healthcare MAC VU360, REF# recall: Software issue issue with the MAC VU360 v3.0 system. After selecting
Software issue issue with the MAC VU360 v3.0 system. After selecting the order refresh icon, an open preview or review screen might fail to close…
-
Class II · 3 months ago
Integrated Medcraft LLC Forward Oral Airway Kit . REF Number: 1011-40002. Containing recall: Devices could potentially contain an occluded or partially occluded Guedel
Devices could potentially contain an occluded or partially occluded Guedel Airway tip.
-
Class II · 3 months ago
Brand Name: OXOS Medical, Inc Product Name: MC2 Portable X-Ray System recall: Due to a defective circuit board that overheats
Due to a defective circuit board that overheats
-
Class II · 3 months ago
Siemens Healthcare Diagnostics, Inc. Atellica CH Urine Albumin REF: 11537225 recall: Processing of urine albumin assay on the CI analyzers may lead
Processing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results…
-
Class II · 3 months ago
United Orthopedic Corp. Brand Name: U2 Total Knee System Product Name: Femoral valgus recall: Due to an incomplete process of the component screw by a subcontractor
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
-
Class III · 3 months ago
Siemens Healthcare Diagnostics, Inc. Syva Emit tox Serum Tricyclic Antidepressant recall: out-of-specification sodium azide concentration in Syva Emit Tox Serum
out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2. While the assay results…
-
Class II · 3 months ago
Instrumentation Laboratory Brand Name: GEM Premier 5000 Product Name: GEM Premier recall: Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000
Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect…
-
Class II · 3 months ago
Argon Medical Devices, Inc L-Cath PICC S/L Peripherally Inserted Central Catheter recall: Catheters, indicated for short/long-term peripheral access to central venous
Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrients; and…
-
Class II · 3 months ago
Stryker Hoffmann II Connecting Rod Micro 3 x 60mm recall: Potential cracking of the Hoffmann II Carbon Connecting Rods following
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
-
Class II · 3 months ago
Medtronic Perfusion Systems Eopa Elongated One-Piece Arterial Cannula Blunt 22FR recall: Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass
Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia…
-
Class II · 3 months ago
Instrumentation Laboratory GEM Premier 5000 with IQM2 Model/ recall: Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000
Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect…
-
Class II · 3 months ago
Windstone Medical Packaging, Inc. AMS Aligned Medical Solutions medical convenience recall: The recall notice was initiated due to a Medicom Urgent Medical Device
The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges…
-
Class II · 3 months ago
Windstone Medical Packaging, Inc. AMS Aligned Medical Solutions medical convenience recall: Windstone Medical Packaging recalled specific items and lots of AMS
Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris…
-
Class II · 3 months ago
Windstone Medical Packaging, Inc. AMS Aligned Medical Solutions medical convenience recall: Windstone Medical Packaging recalled specific items and lots of AMS
Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris…
-
Class I · 3 months ago
Medical Action Industries, Inc. 306 Pack Angiography Ncmc 3/Cs Banner, REF: Ncag62I recall: Cardiovascular procedure kits contain manifolds
Cardiovascular procedure kits contain manifolds, the subject of another recall, that may have particulate within the fluid path, which has the…
-
Class II · 3 months ago
Permobil Inc M5 Corpus Power Wheelchair REF,120032 recall: This recall is being reported retroactively. Power Platform firmware
This recall is being reported retroactively. Power Platform firmware is missing specific drive inhibit logic. This issue may allow the chair to drive…
-
Class II · 3 months ago
Stryker Hoffmann II Connecting Rod Micro 3 x 50mm recall: Potential cracking of the Hoffmann II Carbon Connecting Rods following
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
-
Class II · 3 months ago
Philips Medical Systems Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 recall: The clinical CT scan may not automatically trigger after the Bolus Tracking
The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking…
-
Class II · 3 months ago
Windstone Medical Packaging, Inc. AMS Aligned Medical Solutions medical convenience recall: Windstone Medical Packaging recalled specific items and lots of AMS
Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris…
-
Class II · 3 months ago
Stryker Hoffmann II Connecting Rod Micro 3 x 150mm recall: Potential cracking of the Hoffmann II Carbon Connecting Rods following
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
-
Class II · 3 months ago
Stryker Hoffmann II Connecting Rod Micro 3 x 120mm recall: Potential cracking of the Hoffmann II Carbon Connecting Rods following
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.