Becton, Dickinson and Company is recalling multiple variants of its Swan-Ganz pulmonary artery catheters due to a potential risk of valve leakage that may affect the balloon inflation performance.
3 products
Sun Pharma recalls DOXOrubicin Liposome Injection 50 mg/25 mL vials due to glass particulate matter.
Integra LifeSciences is recalling the Codman CerebroFlo EVD Catheter due to out-of-specification endotoxin results.
Arrow Edge hemodialysis catheterization product recalled: sheath introducer may not split, risking injury.
6 products
BARD Dynamic Deca Steerable EP catheter recalled due to incomplete seals on sterile product.
26 products
Edwards Lifesciences is updating the labeling for the EVOQUE tricuspid delivery system to include a warning about potential functionality issues.
Fly By Jing recalls Creamy Sesame Noodles over possible undeclared peanut allergen.
ZYMUTEST HIA IgG ELISA kit lot FD1265 distributed with outdated flyer containing incorrect positive control values.
Philips is recalling Azurion imaging systems due to potential loosening or breakage of Cable Hose Carrier bolts and plastic parts.
Quidel is recalling QuickVue Dipstick Strep A Test (REF 20108) due to risk of false positive results.
Stryker is recalling the FluidSmart Urology Tube Set (REF LL0006) due to the distribution of nonconforming products.
Hologic recalls Selenia Dimensions mammography systems over loose or broken internal bolts.
2 products
Ascend Laboratories is recalling 25 mg Metoprolol Succinate Extended-Release Tablets due to failed dissolution testing.
Dexcom recalls G7 CGM iOS App (v2.9.0–2.11.2) over glucose alert delays that may cause missed hypo/hyperglycemic events.
4 products
Endo USA recalls Buprenorphine Hydrochloride Injection 0.3mg/mL vials (NDC 42023-179-05) due to particulate matter contamination.
Diowave 250W Laser System recalled; software update needed to correct power output exceeding FDA-cleared 60W limit.
Jolife AB is recalling LUCAS 2, 3, and 3.1 chest compression systems due to missing service documentation.
2 products
MG217 Multi-Symptom Treatment Cream recalled due to Staphylococcus aureus contamination.
Oasis Tears PF eye drops (NDC 42126-6400-1) recalled due to lack of assurance of sterility.
Dakota Honey recalls Spreadable Spun Honey varieties over possible metal/plastic contamination.
5 products
GE HealthCare recalls Revolution Ascend CT over AW Server security vulnerability.
7 products
Medline recalls Namic Angiographic Manifolds (SKU 64038200) due to particulate in the fluid path.
14 products
DonJoy IceMan Classic Cube recalled due to broken connector interrupting cold therapy.
4 products
Orthorebirth recalls BioCera Fibers bone void filler (REFs ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-KC) for out-of-spec.
2 products
Medline is recalling Ancillary Pack-LF and Open Heart Anesthesia ICC-A kits due to potential issues with sterilization and packaging calibration.
58 products
Good & Gather Sesame Teriyaki Chicken with Rice recalled due to undeclared sesame allergen.
Breckenridge Pharmaceutical is recalling Duloxetine 60mg capsules distributed nationwide due to the presence of an impurity above FDA limits.
Acella Pharmaceuticals is recalling Naproxen Oral Suspension, 125 mg/5mL, distributed nationwide due to lead and lithium contamination.
BioFire is recalling the Joint Infection (JI) Panel due to contamination that may cause false positive test results.
Mint Medical is recalling Mint Lesion software versions 3.4.0–3.9.5 due to a risk of data loss or incorrect patient information linking.
One Step 10A in vitro diagnostic test recalled for lack of FDA clearance.
7 products
BioFire is recalling the Spotfire Respiratory/Sore Throat Panel due to the risk of false negative results and control failures.
Katalyst Surgical recalls DEX Ophthalmic Tissue Forceps, model DVF4005-23, due to IFU corrective action.
12 products
John B. Sanfilippo recalls nut mixes over Salmonella risk.
6 products
Woodstock Organic Shelled Edamame recalled over possible metal pieces.
Teva is recalling Octreotide Acetate 30 mg injection kits due to a lack of assurance of sterility.
2 products
Rising Pharma is recalling Enalapril Maleate 20 mg tablets (NDC 64980-688-10) due to failed impurities test.
CareFusion is recalling BD PurPrep sterile solution due to a lack of assurance of sterility and potential product contamination.
2 products
Fresenius recalls DELFLEX dialysis solution due to potential bag leaks compromising sterility.
2 products
Ajanta recalls Duloxetine 30 mg capsules over nitrosamine impurity above FDA limit.
3 products
Physio-Control is recalling various LIFEPAK defibrillators serviced without proper performance inspections, potentially delaying therapy.
Second Nature recalls Keto Crunch Smart Mix 10 oz pouches due to undeclared cashews, pistachios, and dried cherries.
Unichem is recalling 5 mg buspirone hydrochloride tablets due to subpotency, which may reduce the medication's effectiveness.
Spacelabs is recalling the Ultraview SL Command Module due to a manufacturing issue with the electrical leakage tester.
2 products
Centinel Spine recalls Prodisc C SK cervical disc implants due to labeling mix-up (5mm/6mm).
2 products
Cook recalls Centimeter Sizing Catheter (RPN N5.0-35-100-P-10S-PIG-CSC-20) over marker band cracking risk.
3 products
Boston Scientific recalls LUX-DX II Arrhythmia Detector (M302) with LATITUDE DRAGON US Server (6460) over missing PVC Burden and Bradyarrhythmia monitoring.
2 products
Erbe Medical recalls ERBEFLO CleverCap CO2 tubing/cap sets due to risk of water aspiration and respiratory failure.
3 productsIntuitive Surgical is recalling the USM arm sub-assembly for da Vinci X and Xi systems due to a risk of internal screw breakage.
2 products
Intuitive is recalling SureForm 30 Gray stapler reloads due to the risk of an incomplete staple line during surgical procedures.
