Medicines & devicesClass III
Medical Action Industries, Inc. 306 recalls Generic Name: Kit
An internal data-entry error caused kit lot 333606 to be labeled with an expiration date of March 31, 2027, instead of February 28, 2027.
· FDA · CA
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 3, 12:33 AM 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
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 II
Henry Schein Inc. recalls 2 products
Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.
· 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 II
Olympus Corporation of the Americas recalls Olympus 4K UHD LCD Monitor
Potential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss or image abnormalities.
· FDA · Nationwide
Medicines & devicesClass III
Supernus Pharmaceuticals, Inc. recalls Trokendi XR
Failed Dissolution Specifications
· FDA · Nationwide
Medicines & devicesClass II
Chiesi USA, Inc. recalls CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0
Lack of Assurance of Sterility
· FDA · Nationwide
Medicines & devicesClass II
PI CARDIA LTD recalls Pi-Cardia Inc
Transfemoral catheter, positing arm may detached due to weld issue.
· FDA · Nationwide
Medicines & devicesClass II
ConvaTec, Inc recalls Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers: 423703
Urostomy Pouches may leak from cap during use.
· 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
MYLAN PHARMACEUTICALS INC recalls Mycophenolate Mofetil for Injection USP
Presence of precipitate
· FDA · Nationwide
Medicines & devicesClass II
DRG International, Inc. recalls Sperm Ab ELISA
Potential for false negative patient results.
· FDA · Nationwide
Medicines & devicesClass II
IsoTis OrthoBiologics, Inc. recalls OsteoBallast
Demineralized bone matrix (DBM) in resorbable mesh indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis, were filled with approx. 4.5 cc DBM (fill for 45 ¿ 11 mm configuration)
· 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
Aniara Diagnostica LLC recalls 3 products
Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and linea
· 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 II
Maquet Critical Care AB recalls GETINGE Y SENSOR Module
The module did not undergo electrical safety tests and functional tests during production.
· FDA · Nationwide
Medicines & devicesClass II
Medline Industries, LP recalls 4 products
Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced bleach concentration may compro
· 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.