Medicines & devicesClass II
Baxter Healthcare Corporation recalls 17 products
CGMP Deviations
· 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, 7:22 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.
514 recalls
Medicines & devicesClass II
ACCORD HEALTHCARE, INC. recalls 12 products
Subpotent Drug
· FDA · Nationwide
Medicines & devicesClass II
Mallinckrodt Hospital Products Inc. recalls Acthar Gel (repository corticotropin injection)
Presence of particulate matter: glass and stopper piece
· FDA · Nationwide
Medicines & devicesClass II
Volcano Corp recalls Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v
Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment.
· FDA · Nationwide
Medicines & devicesClass II
Heidelberg Engineering GmbH recalls Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex Module Model/Catalog Number: S3610
Wheels may come loose when module is being pushed or pulled during movement or transportation, affecting stability of the stand. The stand may tip over as a result. Falling stand may cause impact or crushing injuries, pa
· FDA · Nationwide
Medicines & devicesClass II
Lutronic Corporation recalls Product Name: DermaV Laser System Model/Catalog Number: DermaV Medical laser device that delivers pulsed laser
Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potentially resulting in patient burn.
· FDA · Nationwide
Medicines & devicesClass I
Given Imaging Ltd. recalls Bravo CF capsule delivery device
Capsule may fail to attach to the esophagus or detach from the delivery device. Risks include patient aspiration/inhalation, perforation of esophagus, obstruction of the airway, hemorrhage/blood loss/bleeding, laceration
· FDA · Nationwide
Medicines & devicesClass II
Boston Scientific Corporation recalls 3 products
There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden Alert may delay clinical evaluation
· FDA · Nationwide
Medicines & devicesClass II
IMRIS Imaging Inc recalls 2 products
The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and unlocked state. This may pose a risk of injury to the patien
· FDA · Nationwide
Medicines & devicesClass I
OPTIMAL BALANCE PHARMACY recalls Glutathione 200 mg/mL
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
· FDA · Nationwide
Medicines & devicesClass II
Zydus Pharmaceuticals (USA) Inc recalls Mirabegron Extended-Release Tablets
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
· FDA · Nationwide
Medicines & devicesClass II
Nipro Renal Soultions USA, Corporation recalls 4 products
Hemodialysis concentrates contain high endotoxin levels
· FDA · Nationwide
Medicines & devicesClass I
Fresenius Kabi USA, LLC recalls Morphine Sulfate Injection
Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
· FDA · Nationwide
Medicines & devicesClass II
Novartis Pharmaceuticals Corporation recalls Diovan (valsartan) 160 mg
Failed Dissolution Specifications
· FDA · Nationwide
Medicines & devicesClass II
PTW FREIBURG recalls Brand Name: VERIQA
When a bolus is included in a treatment plan and sent for secondary dose calculation, the software accounts for it but does not display this clearly, which may lead users to incorrectly omit the bolus during treatment an
· FDA · Nationwide
Medicines & devicesClass II
B Braun Medical Inc recalls Brand Name: Extension Set Product Name: DISCOFIX FOUR WAY STOPCOCK Model/Catalog Number: 456025
Specific lots of Discofix Stopcock Sets recalled due to an incorrect expiration date printed on the carton shipper label.
· FDA · Nationwide
Medicines & devicesClass II
Canon Medical System, USA, INC. recalls Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiography/fluoroscopy system used
Due to the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X-ray interventional systems may become loose.
· FDA · Nationwide
Medicines & devicesClass II
Lupin Pharmaceuticals Inc. recalls Clobetasol Propionate Cream USP
Failed content uniformity specifications.
· FDA · Nationwide
Medicines & devicesClass II
SUN PHARMACEUTICAL INDUSTRIES INC recalls Carbamazepine Tablets
CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
· FDA · Nationwide
Medicines & devicesClass II
Shoolin Pharma Chem LLP recalls 5 products
CGMP Deviations:Noted during FDA inspection
· FDA · Nationwide
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 II
Baxter Healthcare Corporation recalls Brand Name: VOLARA System Product Name: VOLARA
Contamination within the release test equipment flow path could have affected the accuracy of the nebulizer flow rate. Affected devices returned to firm and testing confirmed devices meet specifications.
· 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
New York Embroidery Studio, Inc. recalls New York Embroidery Studio Trinity Non-Surgical Isolation Gown
Gowns do not consistently meet the minimum liquid-barrier performance required.
· 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
Bayer Medical Care, Inc. recalls MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System
Some devices may not have been properly sterilized due to a manufacturing sterilization issue.
· 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
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.