
FDA•MODERATE
PIE PAK Trolley System
Edermy is recalling PIE PAK trolley systems (models P2HC-A, P2HC-S, P2HC) due to a lack of required 510(k) clearance.
2 products
Edermy is recalling PIE PAK trolley systems (models P2HC-A, P2HC-S, P2HC) due to a lack of required 510(k) clearance.
2 products
Slate Run Pharmaceuticals recalls Eptifibatide Injection 75 mg/100 mL vials (NDC 70436-027-80, 70436-163-80) due to incorrect dosing-route labeling.

AvKARE is recalling Amantadine HCl Capsules 100 mg (NDC 50268-069-15) nationwide due to failed dissolution specifications.

LEO Pharma is recalling Adbry (tralokinumab-ldrm) injection due to a lack of sterility assurance following the discovery of wool fiber.

Rosina recalls frozen Bremer Italian Style Meatballs over possible metal contamination.

Gerber Arrowroot Biscuits (5.5 oz, UPC 015000005962) recalled for potential paper/plastic contamination in arrowroot flour.

Hitachi recalls Proton Beam Therapy System over patient positioning software anomaly.
2 products
JJGoo LED balloon lights (Model MY1005E-Colorfu1-100) are recalled due to a serious battery ingestion and chemical burn hazard to children.

Huaker magnetic toy building sets (Model 20A-13) are recalled due to a serious choking hazard from small balls.

Joly's 80% Vinegar is recalled for missing mandatory safety labels, posing risks of poisoning and chemical burns.

Prismatic 3D Prints is recalling Book Nooks because their spare coin batteries are easily accessible, posing a serious ingestion hazard.

Vive Health is recalling models LVA1024 and LVA3031BLK bed rails due to a serious entrapment and asphyxiation risk.

SAMIT youth multi-purpose helmets are recalled for failing federal safety standards, posing a risk of serious head injury or death.

Accord BioPharma is recalling Udenyca injection due to improper storage temperature conditions.

American Health Packaging is recalling Oxycodone 5 mg tablets due to defective blister card seals that may cause tablets to fall out.

Meitheal Pharmaceuticals is recalling Cetrorelix Acetate injection kits due to missing or duplicated needles in the delivery system.

Olympus is recalling the UHI-3 High Flow Insufflation Unit due to a software issue that may cause dangerous overpressure events.
3 products
Laerdal is recalling LCSU 4 RTCA suction units due to potential electromagnetic noise levels exceeding regulatory limits.

Medline is recalling various surgical and biopsy convenience kits due to potential issues with the sterility assurance level.
62 products
Auris Health is recalling MONARCH Platform Bronchoscopy systems due to a software issue that may cause unexpected robotic arm repositioning and contact with the patient.

Stryker is updating the MOLLI 2 System labeling due to the risk of magnetized surgical tools dislodging markers during tissue removal.
2 products
Ambrosia Brands is recalling Rosabella Moringa dietary supplement capsules due to potential Salmonella contamination.

CheerKid baby bath seats (Model BH-222) are recalled due to a drowning hazard, as they can tip over during use.

Watkins is recalling 6-fin hydromassage rotary jets in 2023–2025 Highlife Collection spas due to hair entanglement and drowning hazards.

Beloems model BL-BR201 adult portable bed rails are recalled due to serious entrapment, asphyxiation, and laceration hazards.

Fortemotus adult portable bed rails (model USFTMTJAS008) are recalled due to entrapment, fall, and laceration hazards.

Fresenius Kabi recalls thiamine HCl 500 mg/100 mL IV bags over sterility concerns.
5 products
Integra LifeSciences is recalling MediHoney Gel dressing models 31805 and 31815 due to a potential breach in the sterile packaging barrier.
3 products
SOOWERY 6-Drawer Dressers are recalled due to tip-over and entrapment hazards that pose a risk of serious injury or death to children.

LShome smoke detectors are recalled for failing to sound during a fire, posing a serious injury or death hazard.

Aroeve is recalling model MK04 air purifiers due to an overheating risk that poses fire and burn hazards.

Asteria Health recalls Testosterone 100 mg Sterile Pellets over possible metal contamination.
25 products
Taro Pharmaceuticals is recalling Diclofenac Sodium Topical Gel 3% (100 g) due to viscosity specification failure.

Unichem is recalling Doxazosin Tablets 4 mg (NDC 29300-353-10) due to incorrect tablet imprinting that may cause medication errors.

Granules Pharmaceuticals is recalling Trazodone Hydrochloride 50 mg tablets (NDC 70010-231-01) due to foreign tablets or capsules in bottles.
Philips recalls Azurion 5 M20 and 7 M12 systems over risk of unexpected table movement when Reset Geometry is pressed.
8 products
Alphatec Spine is recalling 10mm Osteotome navigation instruments due to a design flaw in the array connection geometry.
2 products
Pro Numb Tattoo Numbing Spray recalled over cGMP deviations.
2 products
Halyard Transport Bag Kit LIFE0080-01 recalled due to Tyvek bag seal issue that may compromise sterility.

Straumann is recalling WB Impression Post Closed Tray kits (L 13mm) due to incorrect magenta impression caps instead of brown.

Trividia recalls TRUE METRIX meter instructions over inadequate E-5 error guidance.
7 products
EnHomee 10-Drawer Dressers are recalled due to tip-over and entrapment hazards that pose a risk of serious injury or death to children.

Lancaster Table & Seating outdoor chairs and barstools are recalled due to a fall hazard caused by legs that can bend or break during use.

Fixwal 7-drawer dressers are recalled due to tip-over and entrapment hazards that pose a risk of serious injury or death to children.

Aterian is recalling PurSteam Elite and Mighty Lil steamers due to a burn hazard from hot water expulsion.

Cobelae Busy Books are recalled due to a choking hazard from detachable beads on the apple page.

Furnulem 5-drawer dressers (Model HK-DS-017-CL-5D-1-W) are recalled due to tip-over and entrapment hazards.

Scepter B62 fuel containers are recalled for lacking flame mitigation devices and child-resistant spouts, posing fire and poisoning risks.

Little Cow Co. 9 oz candles are being recalled due to fire, burn, and laceration hazards from glass jars that can crack or break during use.

GM Gumili Wintergreen Essential Oil is recalled for failing to meet child-resistant packaging requirements, posing a poisoning risk to children.
