Medicines & devicesClass I
AVID Medical, Inc. recalls Halyard IV START KIT NON-STERILE
Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may be contaminated with Aspergillus penicillioides.
· 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.
321 recalls for “AI”
Medicines & devicesClass II
AVID Medical, Inc. recalls 2 products
Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may exhibit an open or incomplete seal on the packaging of the applicator.
· FDA · Nationwide
Medicines & devicesClass II
Boston Scientific Corporation recalls Boston Scientific Corporation StoneSmart Connect Console Contents: (1) Power Cord
A subset of power adapters used with the connect console may exhibit higher-than-expected resistance in the electrical grounding path. As a result, the power adaptor may fail electrical safety testing during installation
· FDA · Nationwide
Medicines & devicesClass II
Mirion Technologies (Capintec), Inc. recalls Captus 4000e Thyroid Uptake System
Potential for failure of the tension bolt which would allow the spring arm to unexpectedly fall to its lowest position, which is approximately 25 inches (63.5 cm) from the ground.
· FDA · Nationwide
Medicines & devicesClass II
Medline Industries, LP recalls 13 products
Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially co
· FDA · Nationwide
Medicines & devicesClass II
GE Medical Systems Information Technologies Inc recalls 4 products
Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings prev
· FDA · MI, NY
Medicines & devicesClass II
SDI Limited recalls Dentsply Sirona Capsule Mixer Model No
Potential for electrical discharge from unit when unplugged.
· FDA · 48 states
Medicines & devicesClass I
Sunny Pharmtech Inc. recalls 2 products
Presence of Particulate Matter; identified as stainless steel
· FDA · Nationwide
Medicines & devicesClass II
Remel Europe Ltd. recalls Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL
Certain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performing to IFU criteria not positive to ATCC13102 within 60 Seconds.
· FDA · Nationwide
Medicines & devicesClass III
Ascend Laboratories, LLC recalls 3 products
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
· FDA · Nationwide
Medicines & devicesClass II
Fresenius Kabi USA, LLC recalls 5 products
Presence of Particulate Matter: Hair was found in product Presence of Particulate Matter: Hair was found in products
· FDA · Nationwide
Medicines & devicesClass II
Tandem Diabetes Care, Inc. recalls Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application
A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a software issue preventing successful pairing of the t:slim application with Abbott FreeStyle Libre 3 Plus (FSL3P) continuous glucose
· FDA · Nationwide
Medicines & devicesClass II
Straumann USA LLC recalls Straumann Bone Level Tapered (BLT) Implant
Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim may inadvertently contain implants that are 12mm in length instead of 14mm as the labeling would suggest.
· FDA · Nationwide
Medicines & devicesClass II
Biofire Defense recalls FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: (01)00851458005136 The FilmArray NGDS Warrior Pane
Firm has identified mismatches between the outbreak strain and the reference strain used in the development of its qualitative, multiplexed, nucleic acid-based in vitro diagnostic panel test.
· FDA · Nationwide
Medicines & devicesClass III
Asclemed USA Inc. recalls Lidolog Kit
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
· FDA · TN
Medicines & devicesClass II
Rohto-Mentholatum (Vietnam) Co., Ltd. recalls 8 products
Lack of Assurance of Sterility
· FDA · Nationwide
Medicines & devicesClass II
Precision Dose Inc. recalls Glycopyrrolate Oral Solution
Failed Impurities/Degradation Specifications
· FDA · Nationwide
Medicines & devicesClass I
AVID Medical, Inc. recalls Halyard IV START KIT NON-STERILE REF: KRIV26-02
Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which are contaminated with Aspergillus penicillioides
· FDA · Nationwide
Medicines & devicesClass II
AVID Medical, Inc. recalls Halyard IV Start Kit Non-Sterile REF: KRIV26-02
Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which lacks sterility assurance due to to wrinkles in the paper lidding which may breach the seal area.
· FDA · Nationwide
Medicines & devicesClass II
Fresenius Medical Care Renal Therapies Group, LLC recalls 3 products
Complaints of blue-green discoloration in product
· FDA · Nationwide
Medicines & devicesClass II
ConMed Corporation recalls CONMED Linvatec GENESYS CrossFT Suture Anchor with Disposable Driver REF# CFBC-5502B 5
Suture anchor may contain incorrect patient implant card which may result in incorrect device identification and traceability.
· FDA · Nationwide
Medicines & devicesClass II
Boston Scientific Corporation recalls 2 products
Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
· FDA · Nationwide
Medicines & devicesClass II
Cardinal Health 200, LLC recalls 8 products
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
· FDA · Nationwide
Medicines & devicesKids & BabiesClass II
Medline Industries, LP recalls 3 products
Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localiz
· FDA · Nationwide
Medicines & devicesClass II
Siemens Healthcare Diagnostics, Inc. recalls 2 products
Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk of sub-optimal patient treatment, includi
· FDA · Nationwide
Medicines & devicesClass II
Gentherm Medical, LLC recalls 3 products
Overheating of the 115V CPU board may cause the device to shut down.
· FDA · Nationwide
Medicines & devicesClass II
Kico Knee Innovation Company recalls Brand Name: Kico Knee Innovation Product Name: ARVIS SURGICAL NAVIGATION SYSTEM GEN 2 Model/Catalog Number: IN
Due to an internal sensor issue, image displayed with eyepiece may appear tilted relative to the eyepiece housing
· FDA · 20 states
Medicines & devicesClass II
Siemens Healthcare Diagnostics Products Ltd. recalls 2 products
Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
· FDA · Nationwide
Medicines & devicesClass II
Straumann USA LLC recalls GM Helix Implant
There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. If the the incorrect implant is installed, the issue could cause bone compression or dif
· FDA · Nationwide
Medicines & devicesClass II
OBP Medical Corporation recalls OBP Medical
There is a potential for vaginal speculums to contain a burr on the proximal plastic blade, which may introduce a sharp edge in the contact regions for both the patient and the healthcare provider.
· 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.