Class I - Dangerous
BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
Accure Laser System, Model: PFMS00004
Accure Acne
Class I - Dangerous
Laser system's spot tracking system may become misaligned resulting in the possible risk of delivery of higher-than-expected laser energy to epidermal tissue, which may cause blistering.
Model A710 Intellis Clinician Programmer Application, version 2.0.97
Medtronic Neuromodulation
Class I - Dangerous
Medtronic has discovered an instance in which the Intellis A710 Clinician Programmer Application (CP App) could no longer establish a session with the Implantable Neurostimulator (INS) which resulted in the inability for the clinician to adjust stimulation parameters. In the event of this issue, the patient may receive inadequate or excessive therapy and experience non-optimal pain relief.
Class I - Dangerous
BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
CardinalHealth Suction Canister Liner, MEDI-VAC CRD, REF 65651-510
Cardinal Health 200
Class I - Dangerous
The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, due to a misalignment of the liner with the outer hard canister.
Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W .
Maquet Cardiovascular
Class I - Dangerous
Risk of polyimide particulate matter being present on the endoscopic harvesting vessel system. This issue may result in polyimide particulate matter being introduced into the arterial conduit for patients undergoing a coronary artery bypass graft (CABG) or peripheral bypass graft surgery.
A potential for a light system to fall in the operating room.
A potential for a light system to fall in the operating room.
48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R
Smiths Medical Asd
Class I - Dangerous
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.
A potential for a light system to fall in the operating room.
Medex 20IN (50.8CM) INJ LINE ROTATING ADAPT, List Number MX682R
Smiths Medical Asd
Class I - Dangerous
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.
High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123
Percussionaire
Class I - Dangerous
Due to an assembly error within the breathing circuit, their pressure output of the breathing circuit kit can be affected and have severe impact to the end user
A potential for a light system to fall in the operating room.
1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL
Smiths Medical Asd
Class I - Dangerous
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.
Cardinal Health Suction Canister Liner, MEDI-VAC CRD 1000 mL Suction Canister Liner Kit with 6 mm 1.8 m Tube, REF 65651-517
Cardinal Health 200
Class I - Dangerous
The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, due to a misalignment of the liner with the outer hard canister.
Cardinal Health MEDI-VAC CRD Suction Canister Liner, 1000 mL Suction Canister Liner Kit with 5 mm 1.8 m Tube, REF 65651-516
Cardinal Health 200
Class I - Dangerous
The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, due to a misalignment of the liner with the outer hard canister.
MINC+ Benchtop Incubator, Reference Part Number (RPN) K-MINC-2000, Order Number (GPN) G44429
Cook Medical
Class I - Dangerous
The MINC+ device is susceptible to losing temperature control of electrostatic discharge (static electricity) is applied to the lid of the device. This may lead to embryo degeneration necessitating an additional medical procedure for the patient.
VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged.
Greiner Bio-One North America
Class I - Dangerous
Tubes have missing additive/anticoagulant resulting in clotting in most cases. A completely clotted sample would lead to no results being reported, which could lead to a delay in treatment or diagnosis. An erroneous glucose or lactose result from a partially clotted sample could lead to inappropriate treatment.
(1) Patient Information Center iX, Model No. 866389 (2) Patient Information Center iX Expand, Model No. 866390 (3) PIC iX Hardware, Model No. 866424
Philips North America
Class I - Dangerous
Push notifications may fail to send to the user under certain conditions. This could potentially result in patient harm due to delay in detection of a change in patient condition.
HIGH PRESSURE ROTATOR WITH MALE LUER LOCK, List Number MX496HP
Smiths Medical Asd
Class I - Dangerous
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.