
FDA•MODERATE
ERBEFLO CleverCap CO2 Tubing/Cap Sets
Erbe Medical recalls ERBEFLO CleverCap CO2 tubing/cap sets due to risk of water aspiration and respiratory failure.
3 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.

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.

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.

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.

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
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
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.

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
Advanced Bionics is recalling M Zn-Air Battery Paks for sound processors due to a non-compliant battery door design.
2 products
Alcon recalls Systane and GenTeal eye gels over sterility concerns.
2 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.

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.

Clinical Innovations is recalling the Kiwi Omni Vacuum Delivery System (Model VAC-6000MT) due to a risk of device breakage during use.

Hologic is recalling Genius Review Station displays (Model CMP-01669) due to unauthorized user modifications to validated monitor settings.

AMZCMJ DGD children's tower stools are recalled due to collapse, tip-over, and entrapment hazards that pose a risk of serious injury or death.

TOETOL HOME is recalling children's tower stools (model DETD0001) due to serious injury and death risks from entrapment, falls, and tip-overs.

Cpzzkq baby loungers are recalled due to a suffocation hazard that violates federal safety standards for infant support cushions.
