Medicines & devicesClass II
Karl Storz Endoscopy recalls HOPKINS Telescope 30¿
Due to incorrect inside packaging label for eyepiece.
· 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.
514 recalls
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 II
CooperVision, Inc. recalls Brand Name: Pearle Vision 1 day Product Name: (somofilcon A) Contact Lens Model/Catalog Number: Pearle Vision
A small number of lenses within the affected lot are of the incorrect power.
· 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 I
American Regent, Inc. recalls Epinephrine Injection
Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials.
· 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 & devicesKids & BabiesClass I
CooperSurgical, Inc. recalls 2 products
Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pressure, possibly reducing the effectiveness of treatment and
· FDA · Nationwide
Medicines & devicesClass II
Becton, Dickinson and Company recalls ForeSight Elite Tissue Oximetry Cable REF HEMFSM10 UDI-DI code: 00690103210927 The non-invasive ForeSight oxim
Due to incorrect switching of Channel 1 and 2 on the module and flag labels on the tissue oximetry cables.
· 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 II
Church & Dwight Co., Inc. recalls Zicam
CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
· 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
AVID Medical, Inc. recalls 15 products
Product may be potentially contaminated with a lubricant used during the manufacturing process.
· FDA · Nationwide
Medicines & devicesClass II
Merit Medical Systems, Inc. recalls Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam
Microspheres used in embolization of tumors, prostatic arteries, arteriovenous malformations, and blood vessels may have holes in packaging that may affect the sterile barrier, which if used could lead to infection.
· 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
SHANTOU Qiwei industrial Co., Ltd recalls MENOW SUNSCREEN PRESSED POWDER SPF35 PA+++
cGMP Deviations
· FDA · CA
Medicines & devicesClass III
Bionpharma Inc. recalls Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg
Presence of Foreign Tablets/Capsules
· FDA · Nationwide
Medicines & devicesClass II
Golden State Medical Supply Inc. recalls Carbamazepine Tablets
CGMP deviations: tablets with black specks.
· FDA · Nationwide
Medicines & devicesClass II
Maquet SAS recalls PowerLED 300 Concealed Lighting System (PWD30+SF W K3 SPRING ARM A2 FC3 50-100nm) Model Numbers: 1
The potential for the device to detach at the junction between the spring arm and suspension arm and fall causing potential injury.
· 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
Philips North America Llc recalls 4 products
Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.
· FDA
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.