
FDA•MODERATE
Diversatek Viper Balloon Dilator
Diversatek recalls Viper 3-Stage Balloon Dilator (6-7-8mm) due to incorrect inflation tag info.
4 products
Diversatek recalls Viper 3-Stage Balloon Dilator (6-7-8mm) due to incorrect inflation tag info.
4 products
Harrow Eye LLC is recalling FreshKote Lubricant Eyedrops (0.33 fl oz) due to lack of assurance of sterility.

Skin Script Blemish Spot Treatment recalled over failed stability specifications; UPC 6 10563 13873 9.

Avantor is recalling Magnesium Chloride 6-Hydrate Crystal 500G bottles (NDC 10106-2448-1) due to subpotency.

Windstone recalls Custom Convenience Kits Pre Op Kit (Part AMS14433) due to potential IV backflow and priming issues.
3 products
Micro-X is recalling the Rover Mobile X-ray System due to a generator malfunction that can render the device inoperable.

Remel Europe is recalling Oxoid Salmonella 9-O Agglutinating Sera due to potential cross-reactivity and misidentification risks.

Foundation Medicine is recalling Sequencing Agent SEQ0067 component of FoundationOne CDx due to possible false-positive BARD1 variants.

LSL Healthcare recalls Infant Central Line Dressing Change Kit (Model 2925H) due to non-sterile alcohol prep pads.
6 products
Arrow recalls Echogenic Introducer Needle due to incorrectly manufactured liquid adhesive.
13 products
Beckman Coulter is recalling Access Total T4 Calibrator (Catalog No. 33805) due to negative bias causing falsely low results on DxI 600/800 instruments.

SurgiSmoke recalls Flamingo Funnel Small over sterilization drape nonconformance.
3 products
Olympus recalls OER-ELITE connecting tubes (MAJ-2110) due to premature lock lever failure.
12 products
XTANT Medical is recalling nanOss 3D bone graft substitutes due to an incorrect five-year shelf life label.

Leading Pharma is recalling Furosemide Tablets 80 mg (NDC 69315-118-01) due to N-nitroso-Furosemide above recommended limits.

Davol is recalling Avitene Ultrafoam Microfibrillar Collagen Hemostat (Catalog 1050030) due to potential inspect fragment contamination.

Gentuity is correcting HF-OCT Imaging System software (versions 21.11–23.3.13) to prevent inaccurate longitudinal measurements during imaging.

Teva is recalling Claravis 10 mg capsules (NDC 0555-1054-56, 0555-1054-86) due to out-of-specification Tretinoin impurity levels.
3 products
Major Pharmaceuticals is recalling 7 mg Memantine Hydrochloride Extended-Release Capsules due to failed dissolution specifications.

Camber Pharmaceuticals is recalling Pantoprazole Sodium 40 mg tablets (NDC 31722-713-10) due to discoloration.

Medline recalls Namic syringes, guidewires, and tubing due to rescinded 510(k) clearances.
28 products
Medline is recalling convenience kits containing select 10mL polycarbonate syringes due to potential cracking or breakage of the syringe barrel and/or plunger, which could result in loss of sterility and potential patient infection.
21 products
Magellan recalls LeadCare II blood lead test kits over false elevated results from certain micro-collection devices.
4 products
Integra LifeSciences is recalling CUSA Clarity C7000 Console (Software 2.1.1.909) due to unresponsive touch screen.

Angiodynamics recalls Soft-Vu Angiographic Catheters due to guidewire passage defect.
20 products
Windstone recalls kits with Medline Namic RA Syringes over risk of adapter unwinding, which may cause disconnection and serious injury.

The affected units were sold nationwide and include various RGV3 series models with serial numbers starting with EEV, ERV, EAV, EYV, EUV, ELV, or RFV.

ATOYUS children's activity cubes (Model GLBB554) are recalled due to a choking hazard from small parts that can detach.

Zoliquex is recalling model ZEX014-V1 adult portable bed rails due to serious entrapment and asphyxiation hazards.

Fengrong Tool is recalling electric pressure washers due to a serious risk of injury or death from shock and electrocution hazards.

Agiiman pressure washers are recalled due to a lack of GFCI protection, posing a serious risk of electric shock and electrocution.

Fun and Function is recalling model MW7661 metal swing frames due to a fall hazard caused by the frame cracking or breaking during use.

Apex Gaming PCs is recalling Manik and Apex-branded ATX computer power supplies due to missing electrical shock and electrocution hazard labels.

Montessori airplane-shaped teething toys are recalled due to a choking hazard posed by the toy's tentacle ends.

Le Hao Tool is recalling electric pressure washers due to shock and electrocution hazards caused by the lack of a ground-fault circuit-interrupter.

The recall affects units distributed nationwide that have not yet been filled with gasoline.

Patoolio Direct is recalling model W6 and W8 electric pressure washers due to shock and electrocution hazards from a missing GFCI.

nvyue Magic Pocket Staffs are recalled due to projectile and laceration hazards from the staff's sudden, unintentional expansion.

BAYOTAK USA is recalling electric pressure washers (Model C4012PLUS-1500C) due to shock and electrocution hazards from a missing GFCI.

ZMC Group is recalling LED Finger Beam Lights due to a battery ingestion hazard that can cause serious injury or death.

Arch Studio tea kettles are being recalled because the handle can detach when heated, posing a serious burn hazard.

Sanlebi Pet Vet Playsets are recalled due to a battery ingestion hazard that violates federal toy safety standards.

SpringFlower is recalling Montessori toy sets (model SFTODD05IN1) due to a choking hazard posed by the airplane-shaped teething toy.

SEGMART is recalling 55-inch toddler trampolines with accessory kits due to a strangulation hazard from the hammock, punching bag, and rings.

Sweetcrispy is recalling model XCJ-K01 electric pressure washers due to a serious risk of shock and electrocution from a missing GFCI.

Apotex is recalling Desmopressin Nasal Spray (NDC 60505-0815-0) due to defective bottle caps with missing or dislodged liners.
3 products
Medline is recalling CENTURION Circumcision Kit (CIT7050F) due to one lot distributed without sterilization.

Philips Spectral CT on Rails (Model 728334) requires a software update to address gantry positioning, message display, and menu option issues.

International Medication Systems is recalling Epinephrine Injection 1 mg/10mL (NDC 76329-3318-1) due to lack of sterility assurance.

Ayco is recalling whole fresh cantaloupes over potential Salmonella contamination.
