Device Recall
FDA•MODERATE
Mint Lesion Software
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.
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
My Wife's Slaw (original and Jalapeno Heat) recalled for lack of approved food establishment inspection.
2 products
Market of Choice recalls Vegan Kale Caesar Salad over undeclared sesame allergen.

Winfield's CWB Chocolate Bars recalled over undeclared milk allergen.

Cronus Pharma is recalling Amoxicillin and Clavulanate Potassium oral suspension drops for dogs and cats due to product discoloration.
2 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
Walker Honey recalls Fain's creamed honey spreads over possible stainless steel and plastic particles.
10 products
Horizon Organic recalls Chocolate Lowfat Milk 8-oz boxes due to package integrity issues.

...And Kimchi kimchi recalled for undeclared fish allergen.

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
Sungal Inc. recalls XZL Jelly Snacks 12.68 oz bags due to undeclared FD&C Yellow #5, #6, and Red #40.

Montebianco Base Vegan is recalled due to undeclared milk, which exceeds acceptable levels despite the product's warning label.

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.

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
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
Hepo adult portable bed rails are recalled due to serious entrapment, asphyxiation, fall, and laceration hazards.

Acer is recalling AES015 electric scooters due to a loose screw that can cause the front tube to collapse, posing a fall hazard.

Honda is recalling 2025-2026 off-road motorcycles (CRF250/450 series) due to a handlebar clamp defect that poses a crash hazard.

Bayer is recalling 6 mL travel size Afrin Original Nasal Spray due to a lack of child-resistant packaging, posing a poisoning risk to children.

Malker is recalling bicycle light sets due to a battery ingestion hazard that can cause serious injury or death.

1-K Kerosene Heater Fuel containers are recalled due to missing flame mitigation devices and lack of child-resistant closures.

Earthtec pool drain covers are recalled due to entrapment and drowning hazards, as they violate federal safety standards.

Stephan Baby Boo Bunnie and Friends toys are recalled due to choking and laceration hazards from the toy's plastic cube breaking.

Build-A-Bear is recalling Heartwarming Hugs weighted plush bears (model 034464) due to a choking hazard from a detachable zipper slider.

UHOMEPRO 5-drawer dressers are recalled due to tip-over and entrapment hazards that violate federal safety standards.

DGIVOVO US is recalling model C4012PLUS-1500C electric pressure washers due to shock and electrocution hazards from a missing GFCI.

Qumeney bicycle light sets (models BL-01 and BL-02) are recalled due to a battery ingestion hazard that can cause serious injury or death.

Thermos is recalling Stainless King food jars and bottles because the stoppers can forcefully eject, posing impact and laceration hazards.

The StrikeLock hoistway door locking device is recalled due to a risk of serious injury or death from fall hazards.

Segmart 4-Drawer Dressers are recalled due to tip-over and entrapment hazards, as they fail to meet mandatory safety standards.

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.

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
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.
