Class I - Dangerous
Microcatheter may have circumferential defects (cracks) along its shaft.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
These custom sterile surgical kits contain the component, ECOLAB ORS Fluid Warming and Slush Drape, which was recalled due to the possibility that the sterile packaging may contain small channels in the seal of the pouch.
Class I - Dangerous
The products have been found to intermittently exhibit a seal failure during use.
HYDRO-TEMP(R) Neonatal Temperature Skin Sensor, REF HNICU-32, 50 units per box, NON STERILE, Rx only.
DeRoyal Industries
Class I - Dangerous
DeRoyal manufactured four lots of HNICU-32, Hydro-Temp(R) Neonatal Temperature Skin Sensor incorrectly. The pins contained in the probe were soldered incorrectly. When probe is connected to the proper port, this defect results in the inability to read or display temperatures on the infant warming system.
Monitor Ceiling Suspension system may fall
Class I - Dangerous
Stryker Orthopaedics has received two customer complaints regarding Duracon Tibial Wedge implants puncturing the packaging's Tyvek lid(s).
Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1. Indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds.
Merz North America
Class I - Dangerous
The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.
Monitor Ceiling Suspension system may fall
Class I - Dangerous
It was identified by a customer complaint that some I.V. poles were retracting/lowering from an extended position to the low height unexpectedly. An investigation was initiated which identified that the I.V. Latch Housing was nonconforming. potential hazards: " Suspended I.V. pole retracts unexpectedly " Suspended I.V. pole retracts unexpectedly with pump/bags attached
Class I - Dangerous
Miscalibration of the Energy Source monitoring function, which may incorrectly sense the handpiece temperature as higher than the actual handpiece's temperature. This causes some devices to generate a "Check Seal" message with an audible alarm and to stop the heating cycle.
Class I - Dangerous
IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data.
Monitor Ceiling Suspension system may fall
Monitor Ceiling Suspension system may fall
Class I - Dangerous
The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.
NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5
NxStage Medical
Class I - Dangerous
Ultrafiltration (UF) Volume software error inaccurate fluid removal
Class I - Dangerous
It was discovered that the above part number and lot of 2.4mm Locking Screws may contain the incorrect package insert (GP2613, VA-LCP Distal Radius System). The correct package insert for the above part is GP2615 (Modular Mini Fragment LCP System).
Incorrectly packaged with a 90 degree bend at the distal tip
Syngo Imaging VB36D_HF02. Radiological image processing system.
Siemens Medical Solutions USA
Class I - Dangerous
To provide supplementary information regarding the release of the syngo Imaging Software Version VB36D_HF02. The software provides improvements for all syngo Imaging installations running on the software Version VB36D.
These sensors were manufactured with incompatible configurations. This could result in sensors that will provide either no readings or inaccurate readings for the SpCO and SpMet parameters.
BD CD64 APC-R700; Analyte Specific Reagent; Model 657701; Lot No. 4344945, 5037611 and 5063945. Hematology - used as analyte specific reagent - contamination leads to possibility of unexpected staining pattern.
Becton, Dickinson and Company, BD Biosciences
Class I - Dangerous
Three lots of CD64 (MD22) are contaminated with CD4 antibody.