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, 10:21 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
The issue is related to card pouch damage associated with a portion of the lot which was produced on a specific card pouching device, in a specific timeframe, causing a potential risk of false resistant results. False re
· FDA
Medicines & devicesClass II
Momentary absence of On-Screen "X-Ray On" banner during run readiness check.
· FDA
Medicines & devicesClass II
shortfill; reports of empty capsules.
· FDA · Nationwide
Medicines & devicesClass II
CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
· FDA · Nationwide
Medicines & devicesClass II
The kits contain a Retrograde Coronary Sinus Perfusion (RCSP) cannulae that has the potential for a sterile barrier breach. Sterility of the product cannot be assured. If a compromised pouch seal is not identified prior
· FDA · Nationwide
Medicines & devicesClass II
Blood culture convenience kits contain a component subject to a drug recall that due to an an open or incomplete seal on the packaging of the applicator may compromise the component's sterile barrier and if used may lead
· FDA · Nationwide
Medicines & devicesClass I
Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility.
· FDA · FL, IA, KS, MO, OH, VA
Medicines & devicesClass II
Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning.
· FDA · Nationwide
Medicines & devicesClass II
Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
· FDA · Nationwide
Medicines & devicesClass I
Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may be contaminated with Aspergillus penicillioides.
· FDA · Nationwide
Medicines & devicesClass II
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
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
Software issue may cause measurements to be displayed inaccurately.
· FDA · Nationwide
Medicines & devicesClass II
Software issue may cause the ruler measurement to be inaccurate.
· FDA · Nationwide
Medicines & devicesClass II
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
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
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
A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.
· FDA · Nationwide
Medicines & devicesClass II
Due to a firmware defect, the portable organ transfer device datalogger may lose its configuration, resulting in a blank screen and loss of displayed preservation parameters.
· FDA · Nationwide
Medicines & devicesClass II
Potential for electrical discharge from unit when unplugged.
· FDA · 48 states
Medicines & devicesClass I
Presence of Particulate Matter; identified as stainless steel
· FDA · Nationwide
Medicines & devicesClass II
Due to blood-to-glycol leak in the heat exchanger.
· FDA · Nationwide
Medicines & devicesClass II
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
Incorrect Product Formulation
· FDA · GA
Medicines & devicesClass III
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
Presence of Particulate Matter: Hair was found in product Presence of Particulate Matter: Hair was found in products
· FDA · Nationwide
Medicines & devicesClass II
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
Two software related issues: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead to
· FDA
Medicines & devicesClass II
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
Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of ge
· 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.