🏥 Medical Devices Class I - Dangerous
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
All Recalls
95,083 total recalls in our database
Monica Novii Wireless Patch System-Potential battery damage and excess heat through prolonged charging.
VITEK¿ 2 Gram Negative Susceptibility card (AST-N363), IVD, REF 421692, 20 cards per carton.
Biomerieux
🏥 Medical Devices Class I - Dangerous
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004USTMCA85200
Creganna Medical Devices
🏥 Medical Devices Class I - Dangerous
Lack of sterility assurance.
Fem IM Nail 14mmdx48cm right, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Zimmer Biomet
🏥 Medical Devices Class I - Dangerous
Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
Video Naso pharyngo Laryngoscopes
Pentax of America
🏥 Medical Devices Class I - Dangerous
This field action serves to retrospectively document the actions that were taken by Pentax to correct the loose suction arms on eleven (11) models of endoscopes and to notify FDA of these actions taken in 2010-2011.
Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and Kii 5x55mm Optical Z-Thread Dual Pack (CTR14) trocars.
Applied Medical Resources
🏥 Medical Devices Class I - Dangerous
Due to possibility of insufficient sterilization.
🏥 Medical Devices Class I - Dangerous
Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures.
🏥 Medical Devices Class I - Dangerous
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
VITEK¿ 2 Gram Negative Susceptibility card (AST-N315), IVD, REF 417426, 20 cards per carton.
Biomerieux
🏥 Medical Devices Class I - Dangerous
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
GE Healthcare Revolution EVO X-ray system
GE Healthcare
🏥 Medical Devices Class I - Dangerous
It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.
🏥 Medical Devices Class I - Dangerous
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
VITEK¿ 2 Gram Positive Susceptibility card (AST-P644), IVD, REF 418673, 20 cards per carton.
Biomerieux
🏥 Medical Devices Class I - Dangerous
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
GE Healthcare Discovery PET/CT 600,610, 690, 710: Optima PET/CT 560. 560FX X-ray system
GE Healthcare
🏥 Medical Devices Class I - Dangerous
It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.
🏥 Medical Devices Class I - Dangerous
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
Tibial IM Nail 15mmdx44cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Zimmer Biomet
🏥 Medical Devices Class I - Dangerous
Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
🏥 Medical Devices Class I - Dangerous
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
🏥 Medical Devices Class I - Dangerous
Merge PACS did not show unviewed images when the last view was skipped. There is a potential risk to health of a physician misdiagnosis because not all images are available for viewing.
🏥 Medical Devices Class I - Dangerous
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
🏥 Medical Devices Class I - Dangerous
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).