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, 6:23 AM 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 IUpdated
Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
· FDA · Nationwide
Medicines & devicesClass II
The active ingredient concentration in the lysing bag solution of specific GEM Premier 7000 with iQM3 PAK lots did not meet established manufacturing specifications. The malfunction could result in delayed recognition an
· FDA · Nationwide
Medicines & devicesClass II
Convenience kits contain needle free access device that has an improper seal which may result in doming or tearing of the silicone seal.
· FDA · Nationwide
Medicines & devicesClass II
Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures may contain an expired single use endoscopic seal for gynecology use, which could impact the assurance of sterility.
· FDA · Nationwide
Medicines & devicesClass II
Potential for brush heads to break.
· FDA · Nationwide
Medicines & devicesClass II
Under extended clinical use conditions (e.g., long duration studies), moisture generated within the pneumatic circuit may accumulate inside the system's internal tubing or at the hydrophobic filter and waterproof pressur
· FDA · Nationwide
Medicines & devicesClass IUpdated
External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode is pump under-delive
· FDA · Nationwide
Medicines & devicesClass IIUpdated
Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
· FDA · Nationwide
Medicines & devicesClass II
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
· FDA · Nationwide
Medicines & devicesClass II
Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not notified of the change.
· FDA · Nationwide
Medicines & devicesClass II
cGMP deviations
· FDA · CA, FL
Medicines & devicesClass II
The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variab
· FDA · Nationwide
Medicines & devicesClass II
The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variab
· FDA · IA, MN, MO
Medicines & devicesClass II
Defects in the silicone seal, which may result in "doming" of the silicone seal due to improper sealing, potentially leading to fluid occlusion or leakage.
· FDA · Nationwide
Medicines & devicesClass II
Due to catheter separation
· FDA · Nationwide
Medicines & devicesClass II
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
· FDA · MN, NC, TX
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
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
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
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.