💊 Drugs Class I - Dangerous
Lack of assurance of sterility: Bags have potential to leak.
All Recalls
95,075 total recalls in our database
Atorvastatin Calcium Tablets, 80 mg*, 90-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-124-90 UPC 355111124900
Dr. Reddy's Laboratories
💊 Drugs Class I - Dangerous
Presence of Foreign Substance: A product complaint was received for a defective tablet with an embedded foreign object observed in a bottle.
5% Dextrose Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7922-02
ICU Medical
💊 Drugs Class I - Dangerous
Lack of assurance of sterility: Bags have potential to leak.
Atorvastatin Calcium Tablets, 10 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-121-90
Dr. Reddy's Laboratories
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications
💊 Drugs Class I - Dangerous
Lack of assurance of sterility: Bags have potential to leak.
💊 Drugs Class I - Dangerous
Lack of assurance of sterility: Bags have potential to leak.
💊 Drugs Class I - Dangerous
Lack of assurance of sterility: Bags have potential to leak.
🏥 Medical Devices Class I - Dangerous
The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging configuration have the potential for sterile barrier breach, leading to possible risk for infection.
🏥 Medical Devices Class I - Dangerous
Approximately 3.4% of BD Vacutainer Plus Plastic Citrate Blood Collection Tubes (2.7mL) (light blue top tube) will exhibit over fill draw volumes from ~11-14%.
🏥 Medical Devices Class I - Dangerous
The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging configuration have the potential for sterile barrier breach, leading to possible risk for infection.
🏥 Medical Devices Class I - Dangerous
The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging configuration have the potential for sterile barrier breach, leading to possible risk for infection.
Part no. 690.379, Graphic Case F/6.5mm Cannulated Screw Set
Synthes (USA) Products
🏥 Medical Devices Class I - Dangerous
Affected screw gauges incorrectly measure screws 5.41mm shorter than the actual overall screw length.
🏥 Medical Devices Class I - Dangerous
The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging configuration have the potential for sterile barrier breach, leading to possible risk for infection.
🏥 Medical Devices Class I - Dangerous
Issues identified with the monitor including urine output measurement errors, temperature measurement errors and undesired alarms.
🏥 Medical Devices Class I - Dangerous
The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging configuration have the potential for sterile barrier breach, leading to possible risk for infection.
🏥 Medical Devices Class I - Dangerous
During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly dose audits/verification required to comply with the regulations could not be found. Sterilization records indicate that all lots of staples were irradiated to at least the defined dose. There is a risk that this issue could result in patient infection if not properly sterilized.
🏥 Medical Devices Class I - Dangerous
During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly dose audits/verification required to comply with the regulations could not be found. Sterilization records indicate that all lots of staples were irradiated to at least the defined dose. There is a risk that this issue could result in patient infection if not properly sterilized.
🏥 Medical Devices Class I - Dangerous
The supplier of Drainer(R) centesis catheters notified Vascular Solutions, Inc. that there is a potential for certain production lots to contain unsafe levels of bacterial endotoxins.
Potential for the display processor to experience an unexpected failure.
🏥 Medical Devices Class I - Dangerous
The affected devices are manufactured to the same design specification as products intended for sale and use in the US but do not contain the FDA approved labeling (i.e., IFU and Patient Information Brochure). The affected devices were distributed in the US with the IFU intended for use outside of the US