💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility
All Recalls
95,114 total recalls in our database
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility
💊 Drugs Class I - Dangerous
Failed Dissolution Specifications
Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 65162-755-10. NDC# 65162-755-10
Amneal Pharmaceuticals of New York
💊 Drugs Class I - Dangerous
Failed dissolution specifications
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility
stay-safe /Luer Lock Adapter 4 in
Fresenius Medical Care Holdings
🏥 Medical Devices Class I - Dangerous
The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit
Bio-Rad Laboratories
🏥 Medical Devices Class I - Dangerous
Due to incorrect calibrations and controls, their is a potential of incorrect reporting of lower %IS and molecular response values.
Thermalon Stye Compress, Item Number 24352
Bruder Healthcare Company
🏥 Medical Devices Class I - Dangerous
Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or mildew.
Baxter Supple Peri-Guard Repair Patch (legacy product codes): a) PC0404SNBIO, b) PC0608NSBIO, c) PC0814SNBIO, d) PC1016SNBIO
Baxter Healthcare
🏥 Medical Devices Class I - Dangerous
A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable limit for cerebrospinal fluid-contacting devices and Supple Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable limit for cerebrospinal fluid-contacting devices.
🏥 Medical Devices Class I - Dangerous
Neonatal pads are experiencing reduced water flow, which may reduce or prevent water heating or cooling performance of the pads that are part of a temperature management system.
IV Start Kit, containing 1 Saline Syringe 5ml, REF 74654, 100 kits/case, Sterile.
Medical Action Industries, Inc. 306
🏥 Medical Devices Class I - Dangerous
The kits contain saline flush syringes which were recalled by the supplier.
stay-safe /Luer Lock Catheter Ext. 18 in
Fresenius Medical Care Holdings
🏥 Medical Devices Class I - Dangerous
The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
Epix Universal Clip Applier, REF: CA500, STERILEEO
Applied Medical Resources
🏥 Medical Devices Class I - Dangerous
Their is the potential that Universal Clip applier may not load clip after the trigger is actuated.
🏥 Medical Devices Class I - Dangerous
Medline Bulb irrigation syringes recalled due to potential for packaging sterile barrier to be breached, and these syringes were packed inside surgical procedure packs that were subsequently terminally sterilized, so after the packs are opened, syringes should be discarded at surgical case end, and not reshelved, because the use of non-sterile bulb irrigation syringes may increase infection risk.
stay-safe /Luer Catheter Ext. 6 in
Fresenius Medical Care Holdings
🏥 Medical Devices Class I - Dangerous
The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
The stent-graft inside the delivery system was the incorrect size.