
FDA•CRITICAL
MG217 Multi-Symptom Treatment Cream
MG217 Multi-Symptom Treatment Cream recalled due to Staphylococcus aureus contamination.

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

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

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

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.

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

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.
