💊 Drugs Class I - Dangerous
Superpotent Drug: High out of specification results for assay at the 6 month time point interval.
All Recalls
95,094 total recalls in our database
BETTER BRAIDS UN-BRAID (salicylic acid), Le Demelant, Packaged in 12 FL. OZ. (355 ml) Bottles, Over the Counter Only. Distributed by KEYSTONE LABORATORIES, UPC 07059600430.
Keystone Laboratories
💊 Drugs Class I - Dangerous
Microbial Contamination of Non-Sterile Products: Failed S.aureus test.
💊 Drugs Class I - Dangerous
Marketed Without An Approved NDA/ANDA: product is an unapproved drug and additionally 3 lots were found to be subpotent.
💊 Drugs Class I - Dangerous
Failed pH Specifications: Confirmed high out of specification (OOS) results for pH.
🏥 Medical Devices Class I - Dangerous
A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance.
VersaFx Femoral Fixation System Hex head compression screw 4.7 mm dia. 2 inch (51 mm) length 47116202400
Zimmer Manufacturing B.V.
🏥 Medical Devices Class I - Dangerous
A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
🏥 Medical Devices Class I - Dangerous
Certain lots of the Otologic Curved Micro (OCM) Diamond Ball Burrs may be missing the diamond coating and the ball may be the incorrect size.
🏥 Medical Devices Class I - Dangerous
A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance.
ITST intertrochanteric/subtrochanteric fixation 4.5 mm diameter cortical screw, 3.5 mm hex head, 57 mm length 00225305745
Zimmer Manufacturing B.V.
🏥 Medical Devices Class I - Dangerous
A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
Monteris received a report that the sapphire lens on a 2.2SF probe fractured during a LITT procedure, with resulting introduction of C02 into the patient's brain.
🏥 Medical Devices Class I - Dangerous
The product has potential to leak beyond their design specification.
🏥 Medical Devices Class I - Dangerous
The product has potential to leak beyond their design specification.
🏥 Medical Devices Class I - Dangerous
A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
ADVIA Chemistry Triglyceride_2, concentrated; TRIG_c; Catalog # SMN # 10697575. For in vitro diagnostic use in the quantitative measurement of triglycerides in human serum and plasma on ADVIA Chemistry systems.
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
Siemens Healthcare Diagnostics has confirmed the ADVIA Chemistry Triglyceride concentrated reagent (TRIG_c) does not meet Instructions For Use (IFU) linearity claims at the upper limit of the assay range as it approaches end of shelf life for lots # 348297 and 359932.
Potential for the Visualase Cooled Laser Applicator System (VCLAS) catheters to melt during procedures.
Orapharma (Onpharma) Onset Mixing Pen Rx only, Product/Part Number 1054-02. Manufactured for Onpharma Inc. Los Gratos, CA 95030 The Mixing Pen is used to dispense a solution from a standard 3 mL size cartridge into a second fluid container.
Valeant Pharmacueticals International
🏥 Medical Devices Class I - Dangerous
It has been determined that the Onset Mixing Pen has an optimal use period of 18 months from start of use. However, the current labeling and IFU does not stipulate this time period.
🏥 Medical Devices Class I - Dangerous
The product has potential to leak beyond their design specification.
M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 45 mm Length 00225304542 M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 70 mm Length 00225307042
Zimmer Manufacturing B.V.
🏥 Medical Devices Class I - Dangerous
A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
🏥 Medical Devices Class I - Dangerous
Under certain conditions, mass spectrometers may report incorrect quantitative results.
🏥 Medical Devices Class I - Dangerous
Certain lots of the Otologic Curved Micro (OCM) Diamond Ball Burrs may be missing the diamond coating and the ball may be the incorrect size.