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, 1:24 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.
321 recalls for “AI”
Medicines & devicesClass II
A single lot of expired syringes were distributed due to a distribution system control failure.
· FDA · CA, FL, PA
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
Medicines & devicesClass II
The Adapter for Head Positioning accessory may become loose during patient positioning and unintentionally move when used in conjunction with the side rails of the Upper Back Section H V U component on Baxter operating t
· FDA · Nationwide
Medicines & devicesClass II
Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window
· FDA · Nationwide
Medicines & devicesClass I
Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp CGMP Deviations: product manufactured in the same facility under the same conditions as
· FDA · Nationwide
Medicines & devicesClass II
Wilcox is notifying all customers who have purchased a product from the BOSS Xe family that a software enhancement to increase safety has been released and all units should be returned to implement this change.
· FDA · Nationwide
Medicines & devicesClass II
Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.
· FDA · Nationwide
Medicines & devicesClass I
Marketed Without an Approved NDA/ANDA: Product contains undeclared drug ingredients dexamethasone and cyproheptadine.
· FDA
Medicines & devicesClass II
Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).
· FDA · Nationwide
Medicines & devicesClass II
Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate patients, which may distract clinicians away
· FDA · Nationwide
Medicines & devicesClass II
Due to manufacturing issues with the liquid skin adhesive containing in surgical convenience trays/kits.
· FDA · Nationwide
Medicines & devicesClass II
Due to a software issue
· FDA · Nationwide
Medicines & devicesClass II
Due to a software issue which may result in false co-infection (e.g., Positive for Flu A, when SARS-CoV-2 is present).
· FDA · Nationwide
Medicines & devicesClass II
This recall is being reported retroactively. Power Platform firmware is missing specific drive inhibit logic. This issue may allow the chair to drive under restricted conditions, and may create an unstable condition in c
· FDA · Nationwide
Medicines & devicesClass II
Robotic-assisted surgical system arm drapes may detach from the instrument arm due to an issue involving the drape rings located at the top of the product, which may expose a section of instrument arm, which may result i
· FDA · Nationwide
Medicines & devicesClass II
Retrospectively reported correction for an instrument intended for targeted sequencing of DNA libraries from human genomic DNA used with in vitro diagnostic assays has a server with a security vulnerability.
· FDA · Nationwide
Medicines & devicesKids & BabiesClass II
This recall is retroactively being reported. Refurbished bassinets failed to meet quality standards prior to distribution.
· FDA · Nationwide
Medicines & devicesClass II
This recall has been reported retroactively. The power wheelchair firmware lacks a speed restriction to maintain stability when the seat lift exceeds 50 mm, which may cause the user to fall from the wheelchair or the whe
· FDA · Nationwide
Medicines & devicesClass II
Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).
· FDA · Nationwide
Medicines & devicesClass II
Retrospective report of issues remedied in 2019 with firmware and software patches: 1. Defects in optical bench (OPB) firmware V2.19, which affected the accuracy and stability of the pressure signal the AIC system perfor
· 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.