🏥 Medical Devices • 15,809 recalls
Zimmer Biomet
Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.
Philips Electronics North America
If the lock mechanism of the movable camp of the mobile detector holder is not adjusted properly or not secured, the portable detector can drop down when the moveable clamp is at the bottom (below of the detector) and additional force is applied. This may happen when the detector is rotated clockwise from landscape to portrait position.
Zimmer Biomet
Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.
Zimmer Biomet
Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.
Incorrect direct marking and color identification for the affected lot of Ceres Self-Drilling Variable Screws. Although the laser mark and color identify the screws as 12 mm in length, some screws in the lot measure 14 mm in length.
L3 Security & Detection
L3 has determined in airport environments, there have been several cases where a small air gap has developed where the entrance or exit tunnels meet up with the main x-ray scanner tunnel. This a gap in x-ray shielding can result in x-ray emissions that exceed the limit in the federal performance standard for cabinet x-ray systems (see 21 CFR ¿ 1020.40(c)(1)).
Qiagen, GmbH
Certain lots of the QIAamp DSP Virus Kit, REF 60704, used in analytic workflows could result in decreased performance.
Zimmer Dental
Some implant vial caps in the recalled implant lot may inadvertently crack as the result of a manufacturing assembly condition.
Needle Bond may not be able to withstand the tension force applied when the shaped needle is deployed into and retracted from prostate tissue to deliver treatments.
Zimmer Biomet is conducting a medical device recall for the ExploR 6x24mm Implantable Stem with Screw due to a complaint alleging that the Modular Radial HD lock screw was not included in the package for the stem.
Terumo Cardiovascular Systems
Terumo Cardiovascular Systems (Terumo CVS) has received reports of no flow through the over-pressure safety (OPS) Valve.
Terumo Medical
An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath.
The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position.
Terumo Medical
An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath.
Terumo Medical
An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath.
Terumo Medical
An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath.
The infant artwork on the product instructs incorrect pad placement. Also, the artwork is missing the Type BF Patient connection and High Voltage Warning symbols.
Intact carton revealed presence of shredded burn sheets
Terumo Medical
An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath.
Terumo Medical
An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath.