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, 9:21 PM ET · refreshed about every 2.5 hours · RSS · Get recall alerts
State filter: shows recalls whose official distribution lists that state, plus nationwide ones. CPSC and NHTSA recalls apply nationwide.
1107 recalls
Medicines & devicesClass II
The use of a non-validated rework process for assay reagents which could lead to missed diagnosis of renal disease, inappropriate treatment decisions, or inappropriate monitoring of renal disease in intended users.
· FDA
Medicines & devicesClass II
Reduction in the on-board stability of the GSP GALT assay. This may increase the likelihood of run-QC failures and consequently delay the reporting of patient results.
· FDA · Nationwide
FoodClass II
Foreign material (Glass) was found in the product.
· FDA · CT, NJ, NY, PA
Medicines & devicesClass I
Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of residual material. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of
· FDA · Nationwide
Medicines & devicesClass II
The system's 24-hour usage limit results in catheters incorrectly flagged as expired, making them unavailable for clinical procedures.
· FDA · Nationwide
Medicines & devicesClass I
Cardiovascular procedure kits contain manifolds, the subject of another recall, that may have particulate within the fluid path, which has the potential to be introduced into blood circulation and become lodged within bl
· FDA · AZ, CO
Medicines & devicesClass II
Intraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of triggered electromyography (tEMG) functionality during use, displaying as system faults, loss of communication betwee
· FDA · Nationwide
Medicines & devicesClass II
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence o
· FDA · Nationwide
Medicines & devicesClass II
Device not certified - no laser product report was filed with CDRH prior to distribution. Product label incorrectly states device is "Class IV", although Class 1 is appropriate for device. Improperly labeled - omitted la
· FDA · Nationwide
Medicines & devicesClass II
Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem.
· FDA · Nationwide
FoodPublic Health Alert
Public Health Alert · Public Health Alert
· USDA FSIS · IL, IN
Medicines & devicesClass II
Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.
· FDA · Nationwide
Medicines & devicesClass II
Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array.
· FDA · Nationwide
Medicines & devicesClass II
Incorrect concentration of Betadine solution contained within certain AVID convenience kits.
· FDA · Nationwide
Medicines & devicesClass II
User measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular structures may be larger (0.8% to 34.4%) than the actual anatomical dimension, if all the following occur: af
· FDA · Nationwide
Medicines & devicesClass II
Due to out-of-specification, or potential out-of-specification, levels of endotoxins
· FDA · Nationwide
Medicines & devicesClass II
Complaint trend where "Checkline Error" alarm presents at device setup, rendering the CO2 monitoring function inoperable. May result in procedure delay.
· FDA · Nationwide
FoodClass I
Potential Salmonella contamination.
· FDA · IL, WI
Medicines & devicesClass II
Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
· FDA · Nationwide
FoodClass IUpdated
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
· FDA · CT, NJ, NY, PA
Medicines & devicesClass II
Due to an increase rate of balloon pinhole defects.
· FDA · Nationwide
Medicines & devicesClass I
Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path ha
· FDA · Nationwide
Medicines & devicesClass II
Surgical instruments used during shoulder arthroplasty procedures does not progressively translate to replicate implant geometry, so the reaming guide and the stem reamer are positioned approximately 0.2 mm per size more
· FDA · Nationwide
Medicines & devicesClass II
Due to software issues where does not handle combo assay results. The software may replace the final combo test result with one of the sub-results resulting in incorrect reporting of test outcomes.
· FDA · FL, GA, IL, MI, PA
Medicines & devicesClass II
Firmware issue may result in intermittent loss or degradation of powered functionality when paired with compatible stretcher. The issue may lead to the system not operating in powered mode, or exhibiting reduced powered
· FDA · Nationwide
Medicines & devicesClass II
A single lot of expired syringes were distributed due to a distribution system control failure.
· FDA · CA, FL, PA
FoodClass II
Undeclared milk allergen.
· FDA · TX
Medicines & devicesClass II
Due to device not having FDA Clearance
· FDA · Nationwide
Medicines & devicesClass II
Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP.
· FDA · Nationwide
Medicines & devicesClass II
Intraosseous nerve ablation system instruments may have sterile barrier breach of the outer tray seal, which may introduce a risk of sterility breach, and if breached could lead to severe infection.
· 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.