💊 Drugs Class I - Dangerous
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
All Recalls
95,114 total recalls in our database
💊 Drugs Class I - Dangerous
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
💊 Drugs Class I - Dangerous
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
🏥 Medical Devices Class I - Dangerous
Labelled with an incorrect expiry date on the outer label with an extended expiry date than the validated shelf life. The correct expiry date for the device is 2022-02 and not 2023-05 as shown on the outer label.
Compella Therapy Air Supply Unit
Baxter Healthcare
🏥 Medical Devices Class I - Dangerous
Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains.
🏥 Medical Devices Class I - Dangerous
Potential exposure to rodents and rodent activity in the distribution center.
🏥 Medical Devices Class I - Dangerous
May show unexpected locus specific signals in addition to those at 14q32.
🏥 Medical Devices Class I - Dangerous
Incorrect extended expiration dates identified on the outer box label only, if product is used past the correct expiration date there is a potential for pain, infection, or adverse tissue reaction to occur
🏥 Medical Devices Class I - Dangerous
Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical intervention, and/or extension of surgery to find another part.
NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and maxillofacial defects. Catalog Number: 5099250
Ace Surgical Supply Co.
🏥 Medical Devices Class I - Dangerous
NuOss Collagen (dental) was packaged with a Collatene Fibrillar Collagen(for oral wounds) rather than NuOss Collagen Block, may result in suboptimal bone repair
🏥 Medical Devices Class I - Dangerous
Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical intervention, and/or extension of surgery to find another part.
Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical intervention, and/or extension of surgery to find another part.
🏥 Medical Devices Class I - Dangerous
Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical intervention, and/or extension of surgery to find another part.
🏥 Medical Devices Class I - Dangerous
Due to a component in the hemodialysis console there is the possibility of heat-related damage that may occur with the device.
🏥 Medical Devices Class I - Dangerous
Incorrect extended expiration dates identified on the outer box label only, if product is used past the correct expiration date there is a potential for pain, infection, or adverse tissue reaction to occur
🏥 Medical Devices Class I - Dangerous
Units not properly inspected prior to release to the market, may not function as indicated in the product labeling, resulting in syringe detection and infusion accuracy that can result in delays in therapy, overinfusion, or underinfusion.
Compella Bariatric Bed System
Baxter Healthcare
🏥 Medical Devices Class I - Dangerous
Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains.
Azurion systems with software release R2.0.x
Philips Healthcare
🏥 Medical Devices Class I - Dangerous
In the Azurion system, the user can add a new study to a patient by selecting the option "Add Study". The Add Study dialogue box is then displayed where the Patient Type is selected to perform the study. Due to a software defect, when the study is initiated by pressing Start Procedure , the Patient Type changes inadvertently to a Patient Type different than the one selected as shown in the Table below. Patient type is one of the factors involved in the dose control process. The incorrect patient type changes the technique factors to be used by the system without notification to the user.
🏥 Medical Devices Class I - Dangerous
In 2018, Philips Respironics added foam replacement to the preventive maintenance schedule for these devices after discovering the polyester-based polyurethane (PE-PUR) foam may degrade into particles. This 2018 correction has been superseded by the device removal and rework described in Philips Respironics 2021 recall action for the same devices.
Instructions for Use (IFUs) updated to include use of a headband is now recommended for all patients and instructions for the application of the headband. Additionally, IFU updated to include warnings for risk of condensation build up depending on environmental conditions with instructions.