Medicines & devicesClass II
BioFire Diagnostics, LLC recalls 3 products
Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results
· 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, 6:18 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
INTERVASCULAR, SAS recalls Cardioroot Woven Collagen Coated Vascular Graft
Product failed to meet the specified acceptance criteria for Integral Water Permeability (IWP).
· FDA · Nationwide
Medicines & devicesClass I
Abiomed, Inc. recalls 3 products
The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.
· FDA · Nationwide
Medicines & devicesClass II
Straumann USA LLC recalls GM Helix Implant
There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.
· FDA · Nationwide
Medicines & devicesClass II
Shanghai United Imaging Healthcare Co., Ltd. recalls 12 products
Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from
· FDA · Nationwide
Medicines & devicesClass I
Medline Industries, LP recalls 7 products
The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin
· FDA · Nationwide
Medicines & devicesClass II
Baxter Healthcare Corporation recalls 2 products
A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains.
· FDA · Nationwide
Medicines & devicesClass I
Fresenius Kabi USA, LLC recalls Tyenne (tocilizumab-aazg) Injection
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
· FDA · Nationwide
Medicines & devicesClass II
American Contract Systems Inc recalls 3 products
Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant used during the manufacturing process. Use of a contaminated wipe may lead to lo
· FDA · Nationwide
Medicines & devicesClass II
Medline Industries, LP recalls 2 products
Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the potential for a sharp edge/burr on the end of the brush. Potential hazards associated include cut injury/abrasion and
· FDA · Nationwide
Medicines & devicesClass II
Medline Industries, LP recalls 5 products
The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neu
· FDA · Nationwide
Medicines & devicesClass II
Cardinal Health 200, LLC recalls 2 products
The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator. Use of a potentially contaminated applicator could result in no patient harm or may lead to localized skin or s
· FDA · Nationwide
Medicines & devicesClass I
AVID Medical, Inc. recalls 4 products
Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.
· FDA · IL, NC, VA, WY
Medicines & devicesClass I
Bard Access Systems, Inc. recalls 2 products
this is a downstream recall of class I recall RES 98777
· FDA · 50 states
Medicines & devicesClass II
Fresenius Medical Care Renal Therapies Group, LLC recalls 4 products
Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.
· FDA · Nationwide
Medicines & devicesClass II
Philips Ultrasound, LLC recalls Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234
Due to software issue with ultrasound system, doppler sample is displayed shallower than its actual measurement location, potentially causing inaccurate blood flow velocity measurements and misdiagnosis.
· FDA · Nationwide
Medicines & devicesKids & BabiesClass II
Happiest Baby, Inc recalls 2 products
Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA.
· FDA · Nationwide
Medicines & devicesClass II
Atrium Medical Corporation recalls 3 products
An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
· FDA · Nationwide
Medicines & devicesClass II
Baxter Healthcare Corporation recalls 17 products
CGMP Deviations
· 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 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
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
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
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
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.