💊 Drugs Class I - Dangerous
CGMP Deviations: Product manufactured in a facility where methanol was found in other distributed lots of product.
All Recalls
95,025 total recalls in our database
Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz (250 mL), OTC, Manufactured by: Greensys of North America LLC. 5001 W Military Hwy Ste 100 McAllen, TX USA 78503, NDC# 76562-000-85, UPC 6 64213 64350 0
GRUPO YACANA MEXICO SAS DE CV
💊 Drugs Class I - Dangerous
cGMP Deviations
Nature-Throid, 3/4 Grain (48.75 mg) Thyroid U.S.P. 3/4 gr. (48.75 mg)/Liothyronine (T3) 6.75mcg/Levothyroxine (T4) 28.5mcg, 90-count tablets, Rx Only, Mfg: RLC Labs; Cave Creek, AZ, Preferred Pharmaceuticals, Inc. NDC 68788-6860-09
Preferred Pharmaceuticals
💊 Drugs Class I - Dangerous
CGMP Deviations
💊 Drugs Class I - Dangerous
Marketed without an Approved NDA/ANDA; product labeled as Edible Alcohol rendering the product an unapproved new drug and misbranded.
💊 Drugs Class I - Dangerous
GMP Deviations: Potential to contain 1-propanol.
💊 Drugs Class I - Dangerous
GMP Deviations: Potential to contain 1-propanol.
💊 Drugs Class I - Dangerous
Chemical Contamination: Product contains methanol as an active ingredient and is sub-potent for ethanol.
🏥 Medical Devices Class I - Dangerous
The DxA 5000 instructions for use may be confusing regarding the re-use of sample IDs. Beckman Coulter has received complaints where the re-use of sample barcodes were not being detected by the system .
🏥 Medical Devices Class I - Dangerous
The voluntary recall is being initiated due to a manufacturing error resulting in incorrect upper jaw dimensions, and the upper jaw could potentially disengage or detach during use.
PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, PHA01234, PHA01244, PHA01254, PHA01264. Hip prosthesis component.
MicroPort Orthopedics
🏥 Medical Devices Class I - Dangerous
MicroPort Orthopedics Inc. states that there have been reports of fractures of the long and extra-long Titanium modular femoral neck component after implantation. Worldwide there were 680 Long and X-Long PROFEMUR Titanium modular neck fractures among 123,840 global sales representing is a cumulative rate of modular neck device fracture of 0.55% from 2002 to 2019. Within the United States there were 349 Long and X-Long PROFEMUR¿ Titanium modular neck fractures among 15,786 United States sales representing a cumulative rate of modular neck device fracture with a fracture rate in the United States of 2.21% from 2002 to 2019. There is an average time of 5.4 years to device fracture after implantation.
🏥 Medical Devices Class I - Dangerous
LivaNova received complaints indicating the impossibility to collapse Perceval valve during procedure. The Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval implantation. The issue is relevant to specific lots of Dual Collapser size S/M.
Inquiry Steerable Diagnostic Catheter, REF: IBI-81104 - Product Usage: INDICATIONS FOR USE The Inquiry fixed curve and steerable electrophysiology catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies. The catheters are commonly placed at the high right atrium, right ventricular apex, and HIS bundle.
Irvine Biomedical Inc, a St. Jude Medical
🏥 Medical Devices Class I - Dangerous
Steerable diagnostic catheter packages labeled Model IBI-81104, batch 7397352 incorrectly contained Model IBI-87002, batch 7397307. Packages labeled Model IBI-87002, batch 7397307 incorrectly contained Model IBI-81104, batch 7397352.If physicians fail to observe the catheter difference, the intracardiac electrograms will not be representative of the desired signals, could result in procedure delay
NM/CT 850 Model Number: H3907AD
GE Healthcare
🏥 Medical Devices Class I - Dangerous
Rotor bearing screws were found loose on detector.
🏥 Medical Devices Class I - Dangerous
Reagents were shipped to customers after the Use by data indicated on its labeling.
Central Line Dressing Change Tray
Medline Industries
🏥 Medical Devices Class I - Dangerous
Potential of incomplete seals impacting the sterility of the kit.
🏥 Medical Devices Class I - Dangerous
LivaNova received complaints indicating the impossibility to collapse Perceval valve during procedure. The Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval implantation. The issue is relevant to specific lots of Dual Collapser size S/M.
Discovery NM 630 Model # H3101RH
GE Healthcare
🏥 Medical Devices Class I - Dangerous
Rotor bearing screws were found loose on detector.
Speed Stitch Needle Cassette
ArthroCare
🏥 Medical Devices Class I - Dangerous
Due to a supplier error where a portion of the raw material was inadvertently mixed. As a result, some needles may be made of commercially pure titanium as opposed to 304 stainless steel which does not meet the specification and could potentially break during use.
🏥 Medical Devices Class I - Dangerous
LivaNova received complaints indicating the impossibility to collapse Perceval valve during procedure. The Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval implantation. The issue is relevant to specific lots of Dual Collapser size S/M.
EVOLVE STEM 8.5MM Model # 496S085
Wright Medical Technology
🏥 Medical Devices Class I - Dangerous
Lack of sterility assurance