Medicines & devicesClass II
SUN PHARMACEUTICAL INDUSTRIES INC recalls Carbamazepine Tablets
CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
· FDA · Nationwide
Recalls
Safety recalls that rarely make the news, straight from the official U.S. agency records (FDA, USDA, CPSC, NHTSA). Every listing links to its official notice. We only copy what the record says.
Checked Nov 2, 7:07 PM ET · refreshed about every 2.5 hours · RSS · Get recall alerts
FDA drug and medical device recalls.
State filter: shows recalls whose official distribution lists that state, plus nationwide ones. CPSC and NHTSA recalls apply nationwide.
321 recalls for “AI”
Medicines & devicesClass II
Beckman Coulter Mishima K.K. recalls Systems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY ANALYZER AU480 REF / UDI-DI code: B96
Certain AU480 chemistry analyzers, with Windows 10 IoT Enterprise 2021 LTSC PCs, may output the message System Stopped By Fatal Error: DBConnectionError AlarmDB when launching the instrument software, using PC pre-instal
· FDA · Nationwide
Medicines & devicesClass I
Liebel-Flarsheim Company LLC recalls Optiray Imaging Bulk Package-350
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
· FDA · Nationwide
Medicines & devicesClass II
Jenavalve Technology Inc. recalls 3 products
Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.
· FDA · Nationwide
Medicines & devicesClass II
GE Healthcare recalls 6 products
Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record
· FDA · Nationwide
Medicines & devicesClass II
Philips North America recalls 2 products
Due to software malfunction, patient information system may freeze and become unresponsive.
· FDA · Nationwide
Medicines & devicesClass II
Maquet Cardiopulmonary Gmbh recalls 3 products
The packaging may not consistently maintain sterile barrier integrity.
· FDA · Nationwide
Medicines & devicesClass II
Medline Industries, LP recalls 4 products
Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection if product is used.
· FDA · Nationwide
Medicines & devicesClass II
Datex-Ohmeda, Inc. recalls 4 products
Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 100% O2 to the breathing system enabling c
· FDA · Nationwide
Medicines & devicesClass II
GE Medical Systems Information Technologies Inc recalls Carescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04
Device may not resume patient monitoring for at least 3 minutes following system restart. Issue can lead to potential delay in recognition of clinically significant events.
· FDA · Nationwide
Medicines & devicesClass II
Howmedica Osteonics Corp. recalls 12 products
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increas
· FDA · Nationwide
Medicines & devicesClass I
Bard Access Systems, Inc. recalls BD Needle Kit for Powered Driver 15mm x 15Ga
After placement of intraosseous (IO) needle sets, used when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases, users may experience difficulty/inability to remove o
· FDA · 32 states
Medicines & devicesClass II
BioSpectra, Inc. recalls Biospectra Tris/Tromethamine
Failed stability specifications
· FDA · CA
Medicines & devicesClass II
Shilpa Medicare Limited recalls 2 products
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
· FDA · Nationwide
Medicines & devicesKids & BabiesClass I
Nova Biomedical Corporation recalls 5 products
A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient identification (ID) bar
· FDA · Nationwide
Medicines & devicesClass II
Windstone Medical Packaging, Inc. recalls AMS Convenience Kit: DSAEK Pack - RX
The convenience kits contain .0.9% Sodium Chloride Injection, USP products in Single Dose freeflex bags, which may contain blue Break-off-Parts (BOPs) that have detached from the infusion port during manipulation.
· FDA · Nationwide
Medicines & devicesClass II
Cardinal Health 200, LLC recalls 12 products
The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effec
· FDA · Nationwide
Medicines & devicesClass II
Ventec Life Systems, Inc. recalls 3 products
Labeling; Oxygen Cylinders do not contain required medical gas labeling
· FDA · Nationwide
Medicines & devicesNot Yet Classified
Centric Compounding LLC recalls Tri-Immune Boost (Glutathione: 200 mg
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
· FDA · Nationwide
Medicines & devicesClass III
HeartSine Technologies Ltd recalls HeartSine samaritan PAD (Public Access Defibrillator)
Products were distributed without the required Maintenance Supplement, which describes an extra check every 3 months in addition to the monthly check.
· FDA · Nationwide
Medicines & devicesKids & BabiesClass II
HeartSine Technologies Ltd recalls HeartSine SAM 350P 350P US Device
Due to a damaged (over stretched) membrane tail that causes an intermittent fault.
· FDA · Nationwide
Medicines & devicesClass I
American Regent, Inc. recalls 12 products
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde Presence of Particulate Matter: Product contaminated with particulate matter identified as gl
· FDA · Nationwide
Medicines & devicesClass II
Mylan Pharmaceuticals Inc recalls Acamprosate Calcium
Failed Dissolution Specifications
· FDA · Nationwide
Medicines & devicesClass I
Baxter Healthcare Corporation recalls Cefazolin in Dextrose
Presence of Particulate Matter
· FDA · Nationwide
Medicines & devicesClass II
QUANTUM OPS Inc recalls Brand Name: ADAPTABLE Beach Chair Product Name: Beach Chair surgical patient positioner Model/Catalog Number:
Due to a manufacturing issue (inadequate weld) for patient head positioning system.
· FDA · Nationwide
Medicines & devicesClass II
Glenmark Pharmaceuticals Inc., USA recalls Azelaic Acid Gel
CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
· FDA · Nationwide
Medicines & devicesClass II
Medline Industries, LP recalls Medline Convenience Kit: OPEN HEART A PACK
The kits contain a Retrograde Coronary Sinus Perfusion (RCSP) cannulae that has the potential for a sterile barrier breach. Sterility of the product cannot be assured. If a compromised pouch seal is not identified prior
· FDA · Nationwide
Medicines & devicesClass II
Medical Action Industries, Inc. 306 recalls Blood Culture Collection Venipuncture Kit 20/Cs
Blood culture convenience kits contain a component subject to a drug recall that due to an an open or incomplete seal on the packaging of the applicator may compromise the component's sterile barrier and if used may lead
· FDA · Nationwide
Medicines & devicesClass I
Medical Action Industries, Inc. 306 recalls 2 products
Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility.
· FDA · FL, IA, KS, MO, OH, VA
Medicines & devicesClass II
MICRO LABS USA INC recalls Dorzolamide HCl and Timolol Maleate Ophthalmic Solution
Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
· FDA · Nationwide
Recall data comes from official U.S. government sources: openFDA (food, drugs, devices), USDA FSIS (meat, poultry, egg products), CPSC (consumer and children’s products) and NHTSA (vehicles, equipment, car seats). openFDA notes its data should not be relied on for medical decisions. Always confirm with the official notice. Check your vehicle by VIN at nhtsa.gov/recalls.