August 30, 2023Medical DevicesFDA
Randox Laboratories Ltd. recalls Randox Liquid Urine Control Level 2- intended for in vitro diagnostic use, in the quality control of Amylase, Calcium, C
Hazard: (1) There is vial to vial variation resulting in some vials recovering positive for hCG, which should be negative and (2) high and outside range for cortisol. (3) There has been a transcription error for Creatinine in the Instructions For Use (IFU). The target and ranges for Creatinine for the Roche Creatinine Plus method have been listed incorrectly. These failures cause a delay in patient results for the above mentioned analytes.
August 30, 2023Medical DevicesFDA
Invacare Corporation recalls DOLOMITE GLOSS ROLLATOR - intended to support during walking and may also serve as a resting seat. Model Number(s): 1
Hazard: Premature failure of the seat during use, the plastic eyelets of the folding mechanism of the device's seat can break, and in a worst-case crossbar also breaks and the Rollator can collapse causing injury to user
August 30, 2023Medical DevicesFDA
Smith & Nephew, Inc. recalls TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71647340, Femur nail
Hazard: A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT implant instead of a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT as described on the product label.
August 30, 2023Medical DevicesFDA
Smith & Nephew, Inc. recalls TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail
Hazard: A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT implant instead of a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT as described on the product label.
August 30, 2023Medical DevicesFDA
Boston Scientific Corporation recalls EMBLEM MRI S-ICD Pulse Generator Model A219; Subcutaneous Implantable Cardioverter Defibrillator
Hazard: There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, which may cause S-ICD sensing disablement for a 24-hour interval.
August 30, 2023Medical DevicesFDA
Boston Scientific Corporation recalls EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter Defibrillator
Hazard: There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, which may cause S-ICD sensing disablement for a 24-hour interval.
August 30, 2023Medical DevicesFDA
BioFire Diagnostics, LLC recalls FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only
Hazard: Due to manufacturing issue, panels may result in false negative results.
August 30, 2023Medical DevicesFDA
BioFire Diagnostics, LLC recalls BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only
Hazard: Due to manufacturing issue, panels may result in false negative results.
August 30, 2023Medical DevicesFDA
ICU Medical Inc recalls Plum 360 Infusion System, List Numbers: 300100405, 300100409, 300100413, 300100414, 300100415, 300100418, 300100451, 30
Hazard: Due to a manufacturing defect of a supplier provided component, there is a potential that the audible signal for an alarm may not sound under certain conditions.
August 30, 2023Medical DevicesFDA
Draeger Medical, Inc. recalls Carina Sub-Acute Care Ventilator
Hazard: Presence of polyether polyurethane (PE-PUR) and emission of 1,3-Dichloropropan-2-ol that exceed the acceptable uptake level during continuous use (>30 days) in pediatric patients.
August 23, 2023Medical DevicesFDA
Carefusion 2200 Inc recalls Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR DIAMOND JAW 5MM, 45CM, RATCHETED, REF SP90-7271; endoscopic surgical device
Hazard: Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
August 23, 2023Medical DevicesFDA
Carefusion 2200 Inc recalls Snowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER, DOUBLE ACTI 5MM, 45CM, RATCHETED HANDLE, REF SP90-7266; end
Hazard: Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
August 23, 2023Medical DevicesFDA
Carefusion 2200 Inc recalls Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 25 MM JAW 5MM, 45CM, RATCHETED, REF SP90-7243; endoscopic surgical devic
Hazard: Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
August 23, 2023Medical DevicesFDA
Carefusion 2200 Inc recalls Snowden-Pencer MIS DIAMOND-TOUCH ATRAUMATIC GRASPER DIAMOND JAW 5MM, 45CM, RATCHETED, REF SP90-7220; endoscopic surgical
Hazard: Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
August 23, 2023Medical DevicesFDA
Carefusion 2200 Inc recalls Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR DIAMOND JAW 5MM, 32CM, RATCHETED, REF SP90-7071; endoscopic surgical device
Hazard: Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
August 23, 2023Medical DevicesFDA
Carefusion 2200 Inc recalls Snowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER, DOUBLE ACTI 5MM, 32CM, RATCHETED HANDLE, REF SP90-7066; en
Hazard: Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
August 23, 2023Medical DevicesFDA
Carefusion 2200 Inc recalls Snowden-Pencer MIS DIAMOND-TOUCH GRASPER CRILE CURVED JAW 5MM, 32CM, RATCHETED, REF SP90-7048; endoscopic surgical devic
Hazard: Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
August 23, 2023Medical DevicesFDA
Carefusion 2200 Inc recalls Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 60 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7046; endoscopic surgical device
Hazard: Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
August 23, 2023Medical DevicesFDA
Carefusion 2200 Inc recalls Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 50 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7045; endoscopic surgical device
Hazard: Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
August 23, 2023Medical DevicesFDA
Carefusion 2200 Inc recalls Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 35 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7044; endoscopic surgical devic
Hazard: Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
August 23, 2023Medical DevicesFDA
Carefusion 2200 Inc recalls Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 25 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7043; endoscopic surgical device
Hazard: Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
August 23, 2023Medical DevicesFDA
Carefusion 2200 Inc recalls Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR FENESTRATED 16MM JAW 5MM, 32CM, NON RATCHETED, REF SP90-7036; endoscopic surg
Hazard: Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
August 23, 2023Medical DevicesFDA
Carefusion 2200 Inc recalls Snowden-Pencer MIS DIAMOND-TOUCH ATRAUMATIC GRASPER DIAMOND JAW 5MM, 32CM, RATCHETED, REF SP90-7020; endoscopic surgica
Hazard: Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
August 23, 2023Medical DevicesFDA
Carefusion 2200 Inc recalls Snowden-Pencer MIS DIAMOND-TOUCH GRASPER DIAMOND JAW BABCOCK 5MM, 32CM, RATCHETED, REF SP90-7018; endoscopic surgical d
Hazard: Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
August 23, 2023Medical DevicesFDA
Carefusion 2200 Inc recalls Snowden-Pencer MIS DIAMOND-TOUCH GRASPER MCKERNAN FUNDUS 5MM, 32CM, RATCHETED, REF SP90-7012; endoscopic surgical devic
Hazard: Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
August 23, 2023Medical DevicesFDA
Abbott Diabetes Care, Inc. recalls FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 System
Hazard: If blood glucose monitoring system users attempt to start a new sensor, when the old sensor wasn't used for the full 14-day wear time, then the reader may display "Incompatible Sensor" message. If users don't have the previous sensor, or FreeStyle Libre 2 app, or the sensor's full wear time hasn't ended, users may be unable to start a new sensor, which could result in no or delayed glucose results
August 23, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls HF Resection Electrodes - HF resection electrodes are part of a resectoscope system for endoscopic diagnosis and treatme
Hazard: Additional Caution statements in IFU: (1) Due to complaints where the loop wire at the distal end of the HF resection electrode broke after getting in contact with metal objects, such as other endoscopic equipment, implants or stents. As a result, fragments can fall inside the patient and must be retrieved. (2) The second Caution refers to the risk of sparkover when getting in contact with metal parts as this can cause uncontrolled heating of the HF-resection electrode and may result in damage and breakage to the HF-resection electrode tip
August 23, 2023Medical DevicesFDA
Medtronic Neurosurgery recalls Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection sites, Ventricular Catheter, STERI
Hazard: Product labeling contains incorrect expiration date
August 23, 2023Medical DevicesFDA
Alcon Research, LTD. recalls Alcon Custom Pak
Hazard: Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.
August 23, 2023Medical DevicesFDA
Alcon Research, LTD. recalls Phaco Standalone Tips
Hazard: Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.