Medicines & devicesClass II
WELL LEAD MEDICAL CO. LTD recalls SunMed Tracheal Tube
The 6Fr suction catheter could not pass through the samples smoothly.
· 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, 8:51 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.
514 recalls
Medicines & devicesClass II
Johnson & Johnson Surgical Vision, Inc. recalls HEALON EndoCoat PRO
Surgical instructions sent for viscoelastic products used during ophthalmic viscosurgical cataract procedures including in part: If resistance is encountered during insertion, withdraw cannula and reassess the insertion
· FDA · Nationwide
Medicines & devicesClass II
Heritage Pharmaceuticals Inc recalls CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION
Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
· FDA · Nationwide
Medicines & devicesClass II
Datex-Ohmeda, Inc. recalls 4 products
Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 100% O2 to the breathing system enabling c
· FDA · Nationwide
Medicines & devicesClass II
GE Medical Systems Information Technologies Inc recalls Carescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04
Device may not resume patient monitoring for at least 3 minutes following system restart. Issue can lead to potential delay in recognition of clinically significant events.
· FDA · Nationwide
Medicines & devicesClass II
Howmedica Osteonics Corp. recalls 12 products
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increas
· FDA · Nationwide
Medicines & devicesClass I
Bard Access Systems, Inc. recalls BD Needle Kit for Powered Driver 15mm x 15Ga
After placement of intraosseous (IO) needle sets, used when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases, users may experience difficulty/inability to remove o
· FDA · 32 states
Medicines & devicesClass II
Greiner Bio-One North America, Inc. recalls Brand Name: VACUETTE Product Name: LH Lithium Heparin Separator Model/Catalog Number: 454008P Product Descript
Lot B26043FM may include EDTA contamination which introduces potassium while chelating calcium in patient samples, leading to falsely elevated potassium (K+) and falsely decreased calcium (Ca++) results which have the po
· FDA · Nationwide
Medicines & devicesClass II
BioSpectra, Inc. recalls Biospectra Tris/Tromethamine
Failed stability specifications
· FDA · CA
Medicines & devicesClass II
Shilpa Medicare Limited recalls 2 products
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
· FDA · Nationwide
Medicines & devicesClass II
Apollo Care, LLC recalls 11 products
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
· FDA · Nationwide
Medicines & devicesClass II
Prestige Brands Holdings recalls CLEAR EYES Maximum Itchy Eye Relief
Lack of assurance of sterility. The recall is due to potential contamination
· FDA · Nationwide
Medicines & devicesClass II
Fresenius Medical Care Renal Therapies Group, LLC recalls CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors
Communication to recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed.
· FDA · Nationwide
Medicines & devicesKids & BabiesClass I
Nova Biomedical Corporation recalls 5 products
A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient identification (ID) bar
· FDA · Nationwide
Medicines & devicesClass II
Windstone Medical Packaging, Inc. recalls AMS Convenience Kit: DSAEK Pack - RX
The convenience kits contain .0.9% Sodium Chloride Injection, USP products in Single Dose freeflex bags, which may contain blue Break-off-Parts (BOPs) that have detached from the infusion port during manipulation.
· FDA · Nationwide
Medicines & devicesClass II
Diagnostica Stago, Inc. recalls STA Staclot Protein S
A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified
· FDA · Nationwide
Medicines & devicesClass II
Cardinal Health 200, LLC recalls 12 products
The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effec
· FDA · Nationwide
Medicines & devicesClass II
Healthmark Industries Co., Inc. recalls 2 products
Test manufactured with an expired ingredient which may present as either a false negative or positive.
· FDA · Nationwide
Medicines & devicesClass II
Regeneron Pharmaceuticals Inc recalls Libtayo (cemiplimab-rwlc) Injection
Lack of Assurance of Sterility
· FDA · Nationwide
Medicines & devicesClass II
Ventec Life Systems, Inc. recalls 3 products
Labeling; Oxygen Cylinders do not contain required medical gas labeling
· FDA · Nationwide
Medicines & devicesNot Yet Classified
Centric Compounding LLC recalls Tri-Immune Boost (Glutathione: 200 mg
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
· FDA · Nationwide
Medicines & devicesClass III
HeartSine Technologies Ltd recalls HeartSine samaritan PAD (Public Access Defibrillator)
Products were distributed without the required Maintenance Supplement, which describes an extra check every 3 months in addition to the monthly check.
· FDA · Nationwide
Medicines & devicesClass II
restor3d Inc. recalls Kinos Axiom Total Ankle System with Axiom PSR
Ankle implantation systems were packaged with incorrect patient-specific cutting guides, which may result in: delayed surgery, the need to use standard instrumentation, reduced fixation or poor alignment of implants, imp
· FDA · Nationwide
Medicines & devicesKids & BabiesClass II
HeartSine Technologies Ltd recalls HeartSine SAM 350P 350P US Device
Due to a damaged (over stretched) membrane tail that causes an intermittent fault.
· FDA · Nationwide
Medicines & devicesClass I
American Regent, Inc. recalls 12 products
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde Presence of Particulate Matter: Product contaminated with particulate matter identified as gl
· FDA · Nationwide
Medicines & devicesClass II
Mylan Pharmaceuticals Inc recalls Acamprosate Calcium
Failed Dissolution Specifications
· FDA · Nationwide
Medicines & devicesClass I
Baxter Healthcare Corporation recalls Cefazolin in Dextrose
Presence of Particulate Matter
· FDA · Nationwide
Medicines & devicesClass II
Onkos Surgical, Inc. recalls 2 products
Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.
· FDA · Nationwide
Medicines & devicesClass II
QUANTUM OPS Inc recalls Brand Name: ADAPTABLE Beach Chair Product Name: Beach Chair surgical patient positioner Model/Catalog Number:
Due to a manufacturing issue (inadequate weld) for patient head positioning system.
· FDA · Nationwide
Medicines & devicesClass II
Penumbra Inc. recalls Brand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penumbra System (RED 62 Reperfusion Ca
Due to manufacturing issues reperfusion catheters may fracture.
· 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.