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, 5:19 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 II
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. I
· FDA · Nationwide
Medicines & devicesClass II
Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.
· FDA · Nationwide
Medicines & devicesClass II
The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences has identified that the dry time needs to be extended to 90 minutes, 110 minutes, or 120 minutes depending on the
· FDA · Nationwide
Medicines & devicesClass II
May contain incorrect connectors and will not attach or misconnect to ENFit connections and is thus incompatible. Issue could lead to slight delay in delivery of enteral nutritional fluids or oral medication.
· FDA · 18 states
Medicines & devicesClass II
Presence of Foreign Substance
· FDA · Nationwide
Medicines & devicesClass II
Due to off-the-shelf display port component that has audio/video failures
· FDA · Nationwide
Medicines & devicesClass II
Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.
· FDA
Medicines & devicesClass II
Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market.
· FDA · IL
Medicines & devicesClass II
Due to manufacturing issues, reperfusion catheters may fractures
· FDA · Nationwide
Medicines & devicesClass II
Reduced or no recovery of some strains of Neisseria gonorrhoeae.
· FDA · Nationwide
Medicines & devicesClass II
Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma sterilization run (Run ID 1183-28782A) performed by STERIS at its Whippany,
· FDA · Nationwide
Medicines & devicesClass III
Failed Impurities/Degradation Specifications
· FDA · Nationwide
Medicines & devicesClass I
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
· FDA · Nationwide
Medicines & devicesClass II
Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
· FDA · Nationwide
Medicines & devicesClass II
Subpotent drug
· FDA · Nationwide
Medicines & devicesClass II
Problem description/Reason for recall: During the period March 22, 2026, to May 29, 2026, recorded urination audio was captured at 48,000 Hz while the model was trained and validated on 44,100 Hz audio. The models depend
· FDA · Nationwide
Medicines & devicesClass I
Ventilator coaxial breathing circuit may have, expiratory valve sets with membranes sticking to valve body, not detectable during pre-operative test, which will result in "exhalation obstructed " alarm, which may result
· FDA · Nationwide
Medicines & devicesClass II
Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
· FDA · Nationwide
Medicines & devicesClass II
Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm general purpose temperature probe-size 9 d
· FDA · Nationwide
Medicines & devicesClass II
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances
· FDA · Nationwide
Medicines & devicesClass II
A software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circumstances, the pump unexpectedly stops delivering insulin and displays two error messages back-to-back: Pump Error 53 follo
· FDA
Medicines & devicesClass II
Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
· FDA · Nationwide
Medicines & devicesClass II
10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).
· FDA · Nationwide
Medicines & devicesClass II
Pedicle screw system intended to provide immobilization/stabilization of spinal segments as adjunct to thoracic/lumbar/sacral spine fusion may have anti-torque instrument with undersized condition which could prevent mat
· FDA · Nationwide
Medicines & devicesClass I
Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the delivery system under certain procedural or anatomical conditions due to a man
· FDA · Nationwide
Medicines & devicesClass II
Due to reported complaints, the cuff device may alarm with a "Cuff System Leakage" error. As a result, the motor may pump continuously and fail to maintain the cuff pressure set by the user.
· FDA · Nationwide
Medicines & devicesClass IIUpdated
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
· FDA · Nationwide
Medicines & devicesClass IIUpdated
Potential sterile breach of the pouches in which devices are packaged.
· FDA · Nationwide
Medicines & devicesClass IIUpdated
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent
· FDA · Nationwide
Medicines & devicesClass IUpdated
There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, whi
· 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.