Medicines & devicesClass II
Oxos Medical Inc recalls Brand Name: OXOS Medical
Due to a defective circuit board that overheats
· FDA · Nationwide
Recalls
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, 3:52 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
PHILIPS MEDICAL SYSTEMS recalls 3 products
The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadequ
· FDA · Nationwide
Medicines & devicesClass II
Boston Scientific Corporation recalls 4 products
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve d
· FDA · Nationwide
Medicines & devicesClass II
Boston Scientific Corporation recalls FARASTAR Ablation Generator EU
Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.
· FDA
Medicines & devicesClass II
Boston Scientific Corporation recalls 3 products
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
· FDA
Medicines & devicesClass II
Medline Industries, LP recalls 4 products
Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.
· FDA · 10 states
Medicines & devicesClass I
Abiomed, Inc. recalls 13 products
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or
· FDA · Nationwide
Medicines & devicesClass II
ACCORD BIOPHARMA INC recalls IMULDOSA
Lack of assurance of Sterility:
· FDA · Nationwide
Medicines & devicesClass II
McKesson recalls Gemcitabine Injection
Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.
· FDA · Nationwide
Medicines & devicesClass II
Foundation Medicine, Inc. recalls Hamilton Microlab STAR Liquid Handler
Software issue that can cause an increase in spontaneous software closures.
· FDA · Nationwide
Medicines & devicesClass II
Orthofix U.S. LLC recalls 4 products
Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
· FDA · 26 states
Medicines & devicesClass II
ICU Medical, Inc. recalls 2 products
In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.
· FDA · Nationwide
Medicines & devicesClass I
Oscor Inc. recalls 3 products
Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.
· FDA · MA
Medicines & devicesClass II
Medline Industries, LP recalls 2 products
Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of product include clinically insignificant exten
· FDA · Nationwide
Medicines & devicesClass IIUpdated
Zimmer Surgical Inc recalls Brand Name: Sterile Tourniquet Hoses Product Name: A
Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find anot
· FDA · Nationwide
Medicines & devicesClass II
CMR SURGICAL LIMITED recalls Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Catalog Number: V-SS-1020
Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.
· FDA · Nationwide
Medicines & devicesClass II
Asclemed USA Inc. recalls 2 products
Lack of Assurance of Sterility
· FDA · Nationwide
Medicines & devicesClass II
ACCORD HEALTHCARE, INC. recalls Levothyroxine Sodium Tablets
Subpotent Drug
· FDA · Nationwide
Medicines & devicesClass II
Stryker Corporation recalls 5 products
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
· FDA · Nationwide
Medicines & devicesClass II
Hardy Diagnostics recalls HardyDisk AST Cefiderocol 30¿g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30¿g (FDC30) for in vitro agar diff
Due to incorrect cartridges include in affected products that there is the potential for false-susceptible or false-resistant susceptibility results and may lead to selection of an ineffective antimicrobial therapy, pote
· FDA · Nationwide
Medicines & devicesClass II
Windstone Medical Packaging, Inc. recalls 4 products
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 I
Medline Industries, LP recalls 2 products
The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that could result in drug ineffectiveness.
· FDA · CO, IL
Medicines & devicesClass II
Medline Industries, LP recalls 9 products
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary
· FDA · Nationwide
Medicines & devicesClass II
Micro Therapeutics, Inc. recalls 2 products
Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants contain 20 mm implants.
· FDA · Nationwide
Medicines & devicesClass II
ConvaTec, Inc recalls Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3
Surgical dressing manufactured out of specification (greater thickness).
· FDA · Nationwide
Medicines & devicesClass II
Klowen Braces recalls KL Owen Custom Orthodontic Solution
A product error defect may cause incorrect bracket placement.
· FDA · Nationwide
Medicines & devicesClass II
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Enzymatic Hemoglobin A1c (A1c_E)
The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which could cause falsely depressed or falsely elevated HbA1c patient results.
· FDA · Nationwide
Medicines & devicesClass II
Siemens Medical Solutions USA, Inc recalls ARTIS icono ceiling
Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time some screws that keep the monitor attached to the suspension may gradually loosen.
· FDA · Nationwide
Medicines & devicesClass II
ONESOURCE SPECIALTY PHARMA LIMITED recalls Methohexital Sodium for Injection
Failed Impurities/Degradation Specifications
· FDA · Nationwide
Medicines & devicesClass I
Medline Industries, LP recalls 3 products
Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was notified by their sup
· FDA · AZ, CA, FL, IL, IN, NJ, OH, SC
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.