
FDA•CRITICAL
Halyard Cardiac Cath Pack Kit
AVID Medical recalls Halyard Cardiac Cath Pack kits over risk of syringe adaptor disconnection.
10 products
AVID Medical recalls Halyard Cardiac Cath Pack kits over risk of syringe adaptor disconnection.
10 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
Ventec is recalling VOCSN V+Pro respiratory systems (REF: PRT-01198-000, PRT-01185-000) due to potential oxygen leaks that may increase fire risk.

Intuitive is recalling SureForm 30 Gray stapler reloads due to the risk of an incomplete staple line during surgical procedures.

FSIS alert: meat & poultry products with recalled dairy ingredients may be contaminated with Salmonella.

My Mochi Strawberry Non-Dairy Frozen Dessert recalled due to foreign object in container.

Calypso Tropic Tango Lemonade recalled for undeclared Yellow No. 5.

Ganesha Enterprises is recalling KLG Kesar Mukhwas (200 gm) for undeclared food colorings and unapproved dye.

CVS is recalling Lidocaine Wound Gel (NDC 59898-950, 0.5 oz) due to failed pH specifications.

Medline recalls kits with Webcol Alcohol Prep Pads due to possible non-sterility and contamination risk.
10 products
Medline recalls Neuro Sponges (8 sizes) over elevated endotoxin levels.
38 products
Pork King Good recalls Onion & Sour Cream Seasoning due to possible Salmonella contamination.

Hikma is recalling Alendronate Sodium Oral Solution 70 mg/75 mL (NDC 0054-0282-59) due to out-of-specification assay results.

North American Rescue is recalling AIDBAG first aid kits with McKesson TRUE Metrix PRO glucose meters over E-5 error code software defect risking treatment delays.
2 products
Immuno-Mycologics is recalling Myco DDR Trident Neutralization Buffer B due to potential contamination.

Depuy Synthes recalls ATTUNE Revision Hinge Femoral over packaging adhesion that may compromise sterility.
9 products
Siemens is recalling epoc BGEM BUN Test Cards due to inaccurate pH and mTCO2 results that could lead to improper patient treatment.

Straumann recalls n!ce PMMA Full-arch Restoration due to incorrect screw seat interface.
2 products
BD recalls GasPak EZ CO2 and Campy pouch systems over low CO2 output.
2 products
Merit Medical recalls Philips Bridge Prep Kit (REF K12-09098B) over catheter resistance on guidewire.
4 products
Abbott recalls i-STAT EG7+ cartridges (03P76-25) over inaccurate PCO2/pH results.
3 products
Elekta is recalling the Leksell Vantage Arc System due to a risk of coordinate shifting caused by faulty locking mechanisms.

Heraeus recalls PALAMIX uno mixing units: mixing rod may loosen in units over 17 months old; shelf life reduced to 1.5 years.
2 products
Beta Bionics is recalling iLet Bionic Pancreas (software 1.4.2–1.4.3) for Dexcom G7 compatibility issues that may disable glucose correction dosing.

B. Braun Medical is recalling Lactated Ringer's Injection USP due to the presence of particulate matter.

Scope Health is recalling Optase Dry Eye Intense Drops (0.33 fl oz, NDC 72972-002-01) due to lack of assurance of sterility.

Thea Pharma recalls iVIZIA Sterile Lubricant Eye Drops (Povidone 0.5%) over sterility concerns from CGMP deviations.
2 products
Hadson is recalling Negita Cracker Shrimp 2.8 oz over undeclared FD&C Yellow 6.

American Regent is recalling Levocarnitine Injection, USP, 1 g/5 mL single-dose vials due to missing labels.

Lactalis recalls Specially Selected Vanilla Creme Brulee over possible glass fragments.

Wells Pharma recalls injectable drugs (phenylephrine, fentanyl, ketamine) over cGMP deviations.
7 products
Siemens is recalling Dimension Creatinine Flex reagent cartridges (lots GA6307, BA7005) due to potential imprecision in patient creatinine results.

Ghirardelli recalls frappe mixes and hot cocoa over possible Salmonella contamination.
11 products
Philips recalls Achieva 1.5T MRE over stiffness value errors from incorrect voxel size settings.
19 products
Enoki Mushrooms are being recalled due to potential Listeria monocytogenes contamination.

Advanced Bionics is recalling M Zn-Air Battery Paks for sound processors due to a non-compliant battery door design.
2 products
Uncle Giuseppe's Marketplace Milk Chocolate Bridge Mix is recalled for undeclared cashews, milk, and soy allergens.

Alcon recalls Systane and GenTeal eye gels over sterility concerns.
2 products
52USA Popping Boba (Strawberry, Mango, Passion Fruit) recalled for unapproved colors.
6 products
Major Pharmaceuticals is recalling Omega-3-Acid Ethyl Esters Capsules due to failed stability testing for capsule shell loss on drying.

Premier Dental Products is recalling Monsel's Ferric Subsulfate Solution 8 mL vials (NDC 48783-112-08) due to incorrect expiration date on the vial label.

Medtronic Sphere-9 Catheter (Model AFR-00001) may cause ventricular fibrillation in patients with Biotronik ICDs or CRT-Ds during radiofrequency ablation therapy.

Zimmer is recalling Disposable Mixing Bowls with Spatula due to compromised sterile barrier seals that may lead to infection.

Milestone is recalling Vacuum Bag SU Large specimen containers (Model 68409SS) due to possible reagent leakage.

Healthmark is recalling Mesh Style Tip Protectors (models CSW-03-2.0 and CSW-04-4.0) because they lack required FDA clearance.

Boston Scientific updates software for certain pacemakers and CRT-Ps due to bradycardia maintenance release.
3 products
Clinical Innovations is recalling the Kiwi Omni Vacuum Delivery System (Model VAC-6000MT) due to a risk of device breakage during use.
