🏥 Medical Devices Class I - Dangerous
Collagen film was placed on the opposite side of the mesh may cause delay to treatment/therapy, adhesions, erosion/migration, pain, fistula, hernia (recurrence), and failure of implant
All Recalls
95,094 total recalls in our database
MultiLab Series II 2CP & 2CP Express non-invasive vascular diagnostic device, Model Number 11996-0000-01
Unetixs Vascular
🏥 Medical Devices Class I - Dangerous
The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism.
🏥 Medical Devices Class I - Dangerous
Screw connection between the turbine head and the push button may loosen and fall off during the treatment, and increase the risk of swallowing or inhaling part of the turbines head or the push button
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
🏥 Medical Devices Class I - Dangerous
Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output inaccurate blood loss estimates can lead to confusion and could potentially result in either delayed recognition or prolongation of postpartum hemorrhage (PPH), or require more aggressive treatment for PPH.
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
Ultracell Wick with 80cc Collection Bag, 20/box
Beaver Visitec International
🏥 Medical Devices Class I - Dangerous
Device packaging may contain open seals, compromising product sterility.
🏥 Medical Devices Class I - Dangerous
For users with MYLA V4.8.X / V4.9 that use VITEK MS to identify organisms as part of their workflow, AST filter rules that have been activated are not always being applied to AST results when sending the results to the clinician.
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens (extended wear)
CooperVision
🏥 Medical Devices Class I - Dangerous
Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity
Life2000 Ventilator PKG, Hospital, a) REF BT20007, b) REF BT-20-0007, ventilatory support for the care of individuals
Baxter Healthcare
🏥 Medical Devices Class I - Dangerous
There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.
Tibial insert implant large boxes were labeled small and the small boxes were labeled large. If the incorrect labeling is identified this could lead to surgical delay and if the surgeon does not recognize the size discrepancy between the insert label and the pin label, the surgeon may implant the incorrect pin size.
🏥 Medical Devices Class I - Dangerous
Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems.
Sit to Stand STS500 Patient Lift
Med-Mizer
🏥 Medical Devices Class I - Dangerous
Risk of boom pivot failing due to the nut securing the boom becoming loose and the bolt to be unsecure to the flange on the side.
Life2000 Ventilator System, a) REF BT-20-0002, b) REF BT-20-0002A, ventilatory support for the care of individuals
Baxter Healthcare
🏥 Medical Devices Class I - Dangerous
There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.
🏥 Medical Devices Class I - Dangerous
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
🏥 Medical Devices Class I - Dangerous
Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output inaccurate blood loss estimates can lead to confusion and could potentially result in either delayed recognition or prolongation of postpartum hemorrhage (PPH), or require more aggressive treatment for PPH.
🏥 Medical Devices Class I - Dangerous
Stryker has identified a nonconformance in specific lots of Hoffmann LRF Bone Transport Struts. Specifically, the thread pitch is oversized at the distal end of the threaded rod, and as a result the distal ring fixation cannot be locked between 0- 50mm of the threaded rod.
MultiLab Series II REVO non-invasive vascular diagnostic device, Model Number 12950-0000-01
Unetixs Vascular
🏥 Medical Devices Class I - Dangerous
The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism.
Med-Riser MR600 Patient Lift
Med-Mizer
🏥 Medical Devices Class I - Dangerous
Risk of boom pivot failing due to the nut securing the boom becoming loose and the bolt to be unsecure to the flange on the side.