Medicines & devicesClass II
Healthmark Industries Co., Inc. recalls Vinyl Instrument Guards
Labeling not compliant with 21 CFR 801 and steam sterilization IFU has been updated.
· 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 2, 1:42 PM 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.
482 recalls
Medicines & devicesClass II
INTELERAD MEDICAL SYSTEMS INCORPORATED recalls IntelePACS
Following a Chromium-based web-browser, report and displayed images may not match.
· FDA · Nationwide
Medicines & devicesClass II
Pfizer recalls Dopamine HCl Inj
Lack of Assurance of Sterility
· FDA · Nationwide
Medicines & devicesClass III
Magellan Diagnostics, Inc. recalls LeadCare II Blood Lead Test Kit
In kit sub-lot 2530M-01 the date of expiration printed on the outer labeling may indicate the wrong expiration date of July 22, 2026 while the correct expiration date is July 13, 2026. If used the system will display an
· FDA · Nationwide
Medicines & devicesClass II
Inventia Healthcare Limited recalls Chlorthalidone Tablets
Failed Dissolution Specifications
· FDA · Nationwide
Medicines & devicesClass II
OurPharma LLC recalls fentaNYL Citrate
Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and 11/30/2026) and the product expiry (12/09/2026).
· FDA · Nationwide
Medicines & devicesClass I
Instrumentation Laboratory recalls 2 products
Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.
· FDA · Nationwide
Medicines & devicesClass II
W L Gore & Associates, Inc. recalls Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis
The potential for the devices to be mislabeled with the incorrect length.
· FDA · Nationwide
Medicines & devicesClass I
Draeger, Inc. recalls VentStar Resus Neo
Potential cracks in the hose, which could lead to leakage or the hose falling off.
· FDA · Nationwide
Medicines & devicesClass II
Medline Industries, LP recalls 12 products
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
· FDA · Nationwide
Medicines & devicesClass II
Safeguard US Operating LLC recalls Battle Bandage
Compression bandage may be degraded, which may cause unwanted foreign material to be introduced inside the wound, which may lead to wound exploration and irrigation, formation of scar tissue, and infection.
· FDA · Nationwide
Medicines & devicesClass II
Beckman Coulter Inc. recalls 2 products
Beckman Coulter has identified a software issue affecting DxC 500i Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to use units different from the system default,
· FDA · Nationwide
Medicines & devicesClass II
SV Labs Toronto Corporation recalls 2 products
Microbial contamination of topical product.
· FDA · IL
Medicines & devicesClass II
TerSera Therapeutics LLC recalls Zoladex (goserelin) implant
Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient outdoor conditions for 25.5 hours.
· FDA · Nationwide
Medicines & devicesClass II
SUN PHARMA /TARO recalls Lidocaine Ointment USP
Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH).
· FDA · Nationwide
Medicines & devicesClass III
Supernus Pharmaceuticals, Inc. recalls Trokendi XR
Failed dissolution specifications.
· FDA · Nationwide
Medicines & devicesClass II
Medline Industries, LP recalls 6 products
Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures.
· FDA · Nationwide
Medicines & devicesClass II
Steris Corporation recalls 6 products
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator
· FDA · Nationwide
Medicines & devicesClass III
Mindray DS USA, Inc. recalls 8 products
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
· FDA · Nationwide
Medicines & devicesClass II
Amneal Pharmaceuticals of New York, LLC recalls Exenatide Injection
Defective Delivery System: Possibility of no medication in the prefilled pen.
· FDA · Nationwide
Medicines & devicesClass II
Intellijoint Surgical, Inc. recalls Intellijoint Navigation System: Workstation G2 Configured
A navigation system used to aid in selection and positioning of orthopedic implant system components has a workstation that may contain a 15-inch MacBook Pro battery, subject to an Apple battery recall, that may overheat
· FDA · Nationwide
Medicines & devicesClass II
LeMaitre Vascular, Inc. recalls TufTex¿ Over-the-Wire Embolectomy Catheter
Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing.
· FDA · Nationwide
Medicines & devicesClass II
Philips North America recalls 12 products
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction w
· FDA · Nationwide
Medicines & devicesClass III
Macleods Pharmaceuticals Limited recalls Olanzapine Tablets
Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
· FDA · Nationwide
Medicines & devicesClass II
Merit Medical Systems, Inc. recalls Scout MD
The implantable clip may experience difficulties deploying, which could prevent the reflector from functioning as intended during use.
· FDA · AZ, CA, FL, IN, LA, NV, RI
Medicines & devicesClass II
Olympus Corporation of the Americas recalls Olympus Tripp-Lite P580-025 25ft DisplayPort Cable
While in the high-power operating mode, a video dropout/blackout may occur when using a particular accessory cable.
· FDA · Nationwide
Medicines & devicesClass II
Mylan Pharmaceuticals Inc recalls Carton label: Mycophenolate Mofetil for injection
Failed Dissolution Specifications
· FDA · Nationwide
Medicines & devicesClass II
GRI Medical & Electronic Technology Co., Ltd. recalls HALYARD Laparoscopy Comprehensive Pack II REF: 49332
Laparoscopy packs labeled as "latex free" were found to contain a latex urethral catheter
· FDA · Nationwide
Medicines & devicesClass II
Canon Medical System, USA, INC. recalls Alphenix INFX-8000C/B5
Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in [positional/imaging/patient] misalignment and a longitudinal motion error
· FDA · Nationwide
Medicines & devicesClass III
Ajanta Pharma USA Inc recalls Fluphenazine Hydrochloride Tablets
Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.1 percent. Spec: 1.0 percent.
· 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.