The terminals on the plug may become loose and overheat.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Affixus Hip Fracture Nail Right 125 9 mm x 460 mm, Item Number 814311460 Product Usage: Intended for the fixation of fractures
Zimmer Biomet
Class I - Dangerous
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
Affixus Hip Fracture Nail 130 11 mm x 180 mm, Item Number 814511180 Product Usage: Intended for the fixation of fractures
Zimmer Biomet
Class I - Dangerous
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
Class I - Dangerous
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
Affixus Hip Fracture Nail Left 125 9 mm x 460 mm, Item Number 814409460 Product Usage: Intended for the fixation of fractures
Zimmer Biomet
Class I - Dangerous
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
Affixus Hip Fracture Nail Right 125 9 mm x 260 mm, Item Number 814309260 Product Usage: Intended for the fixation of fractures
Zimmer Biomet
Class I - Dangerous
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
Atellica IM CKMB Master Curve Material, Cat No. 10995534 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.
Siemens Healthcare Diagnostics
Class I - Dangerous
A potential bias was identified with certain kits compared to the internal standards.
Gibco MEM Non-Essential Amino Acids Solution (100X) (SKU 11140050), for In-Vitro Diagnostic Use
Life Technologies
Class I - Dangerous
Leaky bottles due to a defect in the bottle cap compromising the sterility of the product
Class I - Dangerous
The conduit length and branch length of a SG Pulmonary Hemi-Artery were switched on the product labeling. The graft labeling indicates the conduit length is 1.0cm and the branch length is 4.5cm.
Class I - Dangerous
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
Affixus Hip Fracture Nail Left 125 13 mm x 360 mm, Item Number 814413360 Product Usage: Intended for the fixation of fractures
Zimmer Biomet
Class I - Dangerous
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMaster 700, REF 1932-169 SN 1185393 2017-09-01
Carl Zeiss Meditec AG
Class I - Dangerous
Calibration setting was incorrectly entered during manufacturing causing the optical coherence tomography (OCT) to obtain the incorrect two-dimensional images of ocular structures of the anterior and posterior segments of the eye.
These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip
Affixus Hip Fracture Nail Right 130 9 mm x 320 mm, Item Number 814509320 Product Usage: Intended for the fixation of fractures
Zimmer Biomet
Class I - Dangerous
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
Affixus Hip Fracture Nail 125 9 mm x 180 mm, Item Number 814309180 Product Usage: Intended for the fixation of fractures
Zimmer Biomet
Class I - Dangerous
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
Class I - Dangerous
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
Class I - Dangerous
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
Class I - Dangerous
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00
Mindray DS USA, Inc.
Class I - Dangerous
The firm has identified performance anomalies with the device caused when more than 64 TD60 telemetry transmitters have been connected to a central station. The anomaly causes some ECG waveforms to appear as a flat line at the centralized viewing station and will manifest if more than 64 TD60 transmitters have been connected to a given central station server. Each central station supports only 32 transmitters at a time. For the issue to manifest, the BeneVision DMS needs to be configured to use flexible device assignment, have more than 64 TD60 transmitters, and the workflow must allow 64 TD60s to move around between multiple central stations in the same care area.
Affixus Hip Fracture Nail Right 125 9 mm x 380 mm, Item Number 814309380 Product Usage: Intended for the fixation of fractures
Zimmer Biomet
Class I - Dangerous
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.