Medicines & devicesClass II
Medline Industries, LP recalls 11 products
Kits contain a potentially contaminated component which were recalled by the manufacturer
· 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, 8:51 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
AVID Medical, Inc. recalls Halyard LAVH PACK
The kit component was subjected to EO sterilization, contrary to the manufacturer recommendation, which may have led to the component leaking in a kit.
· FDA · Nationwide
Medicines & devicesClass II
GE Medical Systems Information Technologies Inc recalls GE Healthcare Portrait Core Services SW V 1
A software vulnerability may allow unauthorized persons to gain privileged access to the device, which could result in loss of patient monitoring, missed patient alarms, and/or access to Protected Health Information (PHI
· FDA · Nationwide
Medicines & devicesClass II
AVID Medical, Inc. recalls 7 products
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
· FDA · Nationwide
Medicines & devicesClass I
Boston Scientific Corporation recalls 2 products
Potential for arterial sheath tip separation or partial tip separation during use.
· FDA · Nationwide
Medicines & devicesClass II
Ascend Laboratories, LLC recalls Amlodipine and Olmesartan Medoxomil Tablets
Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
· FDA · Nationwide
Medicines & devicesClass II
Medline Industries, LP recalls 4 products
Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neurosponges.
· FDA · Nationwide
Medicines & devicesClass II
Tobii Dynavox Llc recalls 2 products
Under certain conditions, the battery mounting tabs may become damaged, allowing the battery to move within the device enclosure, potentially leading to an internal short circuit. This may cause localized heating and gas
· FDA · Nationwide
Medicines & devicesClass II
Fort Defiance Industries, LLC recalls Fort Defiance Industries (FDI)
The Automated Field Steam Sterilizer's water recovery system 120V Amphenol connector may experience an intermittent loss of ground continuity, which could result in an unreliable fault current return path.
· FDA · Nationwide
Medicines & devicesClass II
INTEGRATED MEDCRAFT LLC recalls 2 products
Devices could potentially contain an occluded or partially occluded Guedel Airway tip.
· FDA · Nationwide
Medicines & devicesClass III
Supernus Pharmaceuticals, Inc. recalls Trokendi XR
Failed Dissolution Specifications
· FDA · Nationwide
Medicines & devicesClass I
Spectra Medical Devices, Llc recalls Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection
Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to microorganisms, endotoxins, or foreign matter. This m
· FDA · CA, FL, NC, OK, TX, VA
Medicines & devicesClass II
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo-Model
The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a prolonged or modified surgery as the plateau cannot be inserted
· FDA · IN
Medicines & devicesClass II
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Urine Albumin REF: 11537225
Processing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results; Falsely depressed Atellica CH Enzymatic Hemoglobin A1c (A1c_E) results;
· FDA · Nationwide
Medicines & devicesClass II
DRG International, Inc. recalls Sperm Ab ELISA
Potential for false negative patient results.
· FDA · Nationwide
Medicines & devicesClass I
Victory Medical Center Pharmacy recalls Glutathione (MDV)
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
· FDA · Nationwide
Medicines & devicesClass II
Philips North America Llc recalls 2 products
Device will intermittently provide inaccurate data related to native heart rate.
· FDA · Nationwide
Medicines & devicesClass II
Biomet, Inc. recalls 5 products
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
· FDA
Medicines & devicesClass II
Stryker GmbH recalls 7 products
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
· FDA · Nationwide
Medicines & devicesClass III
Ascend Laboratories, LLC recalls 2 products
Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.
· FDA · Nationwide
Medicines & devicesClass II
Fresenius Medical Care Renal Therapies Group, LLC recalls Fresenius Medical Care
Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-, or temperature-related alarms with the 2008T¿ BlueStar Hemodialysis machines.
· FDA · Nationwide
Medicines & devicesClass II
restor3d Inc. recalls Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas Standard Glenoid Baseplate Model/Cat
Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws.
· FDA · Nationwide
Medicines & devicesClass I
Baxter Healthcare Corporation recalls Baxter Duo-Vent Solution Set and Male Luer Lock Adapter
Baxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cuff is in use or when the tubing is flushed at the fully open position.
· FDA · Nationwide
Medicines & devicesClass II
Merge Healthcare, Inc. recalls 2 products
Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open.
· FDA · Nationwide
Medicines & devicesClass II
KENT IMAGING, INC. recalls SnapshotGLO Wound Imaging Device
The software controlling the wound imaging device's battery charging circuit was not designed to recognize and recover a battery that has fully discharged into a low-power "shipping mode." When this occurs, an affected d
· FDA · Nationwide
Medicines & devicesClass II
Boston Scientific Corporation recalls Rapid Refill Continuous Injection System
Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifold, resulting in loose connection or complete disconnection.
· FDA · Nationwide
Medicines & devicesClass II
Cipla USA, Inc. recalls 3 products
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
· FDA · Nationwide
Medicines & devicesClass II
American Contract Systems Inc recalls 4 products
The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable perfor
· FDA · Nationwide
Medicines & devicesClass II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD
Firmware issue potentially leading to loss of geometry movements.
· FDA · Nationwide
Medicines & devicesClass II
GE Medical Systems Information Technologies Inc recalls GE Healthcare MAC VU360
Software issue issue with the MAC VU360 v3.0 system. After selecting the order refresh icon, an open preview or review screen might fail to close automatically after 2 minutes of inactivity. As a result, data from a prev
· 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.