All recalls
Physio-Control Infant/Child Reduced Energy Defibrillation Electrodes
Infant/Child Reduced Energy Defibrillator Electrodes may delaminate, which can affect defibrillation.
Medartis APTUS TriLock Screws
APTUS TriLock Screws may be mixed up between specified lots of 2.5mm and 2.8mm outer diameter screws.
2 products
Huvepharma BioCox 60 Type A Medicated Article
BioCox 60 failed to meet stability specification requirements for assay.
Vegetarian Chicken Flavor Ramen Express
Vegetarian chicken flavor ramen contains undeclared Yellow #5.
2 products
Exactech Equinoxe Ergo and Equinoxe Core Instrument Kits
The Equinoxe Core Instrument Kit and Ergo Modular Impactor Handle may have a missing cross-pin in the impactor handle.
2 products
Penner Pacific Bathing Spas
The Penner Pacific Bathing Spa lacks a unique device identifier.
10 products
C2O Coconut Water with Pulp
The outer cardboard box for the canned coconut water has incorrect nutrition facts and ingredient list, not including added sugar.
Raz Mobile Shower Commode Chairs
Mobile shower commode chairs may be reinstalled without properly engaging the outside rear seat brackets that keep the seat in place.
Medline Unna-Z Stretch Zinc Paste Bandage
The zinc paste bandage has a labeling error with incomplete ingredients listed.
BD 10mL Luer-Lok Tip Syringes
The syringe may contain Luer Slip syringes instead of Luer Lok.
IBA Proton Therapy System - PROTEUS 235
The IBA Proton Therapy System - PROTEUS 235 has a disabled beam triggering interface, which may lead to mistreatment.
Mercedes-Benz GLA 250
The GLA 250 has an incorrectly installed cable that can prevent the door from opening, trapping occupants and increasing injury risk.
Pebble 2026 Flow Recreational Trailers
The 2026 Flow recreational trailers have solar panels that may detach, becoming a road hazard and increasing crash risk.
Kia Telluride (2027) and Kia K4 (2026)
The rear seat belt buckles in certain Kia K4 and Telluride vehicles may not latch, increasing injury risk in a crash.
Tomum Minoxidil Hair Serum Spray Bottles
Tomum Minoxidil Hair Serum Spray Bottles are not child-resistant, posing a risk of serious injury or death from poisoning if swallowed by young children.
Cubimana Island Storm 3 In 1 Building Sets
Cubimana Island Storm 3 In 1 Building Sets have easily accessible button cell batteries that can cause serious injury or death if swallowed.
Forever 21 Kids Disney Mickey Mouse Pajama Pants
These children's pajama pants violate flammability standards, posing a burn hazard and risk of serious injury or death.
HALO Magic Sleepsuits
The zipper head can detach from certain sleepsuits, posing a choking hazard to infants.
Funaros Perfect Pasta Lobster & Crab Ravioli
Lobster & Crab Ravioli contains undeclared shrimp, crab, lobster, pollock, whiting, and soy.
Nomida Semaglutide and Tirzepatide Injections
Semaglutide and tirzepatide injections lack assurance of sterility.
4 products
Radnostix Sodium Iodide I-131 Oral Solution
Sodium Iodide (I-131) Solution contains particulate matter due to production issues.
Olympus ShockPulse-SE Lithotripsy System with Generator
The Olympus ShockPulse-SE Lithotripsy System has a mis-wired component that can cause noise and delay treatment.
Forest River Impression (2026)
The Forest River Impression fifth wheel trailer has improperly stripped wires that can cause electrical arcing and a fire risk.
Escape: E17, E19, E21, and E5.0 (2025)
The spare tire carrier on certain Escape recreational trailers may detach, becoming a road hazard and increasing crash risk.
Forest River Dynamax Europa and Grand Sport GT Motorhomes
Dynamax Europa and Grand Sport GT motorhomes have a distribution panel that may not be properly grounded, risking injury and electrocution.
Webasto CV Standard Gen1 Batteries
The high voltage batteries may fail, causing loss of drive power and increasing crash risk, or a fire.
GM: Express Cutaway and GMC Savana Cutaway (2025-2026)
Tire sidewall damage on certain GMC Savana and Express Cutaway vehicles may cause sudden air loss or loss of control.
Chevrolet Silverado 3500 and GMC Sierra 3500 (2025-2026)
The rear fuel pump may not transfer adequate fuel to the front tank, causing an engine stall.
Mitsubishi Fuso Rizon FEC7K (E16) (2024), FEC9K (E18) (2024), and FECXK (E18) (2025)
A software error may prevent the truck from being driven, increasing the risk of a crash.
Toyota Highlander and Highlander Hybrid (2021-2024)
The second-row seat backs may fail to lock, increasing the risk of injury during a crash.
Mohamed Hagar Mojo Max Fusion XXX Capsules
Mojo Max Fusion XXX contains undeclared sildenafil and tadalafil.
Advanced Bionics HiResolution Bionic Ear System Sky CI M90 Sound Processor
The Sky CI M90 Sound Processor has a packaging label that differs from the included product.
MR. 7 Super 700000 Capsules
Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil.
Vergani 1944 Milano Pandoro Classico Gluten Free
The gluten-free pandoro may contain Teflon fragments from flaking cooking molds.
Karns Foods Mini Dark Chocolate Raspberry Cups
Mini Dark Chocolate Raspberry Cups may contain undeclared peanuts, posing a risk of serious allergic reaction.
Rising Pharmaceuticals Temozolomide Capsules, 5mg
Temozolomide Capsules failed impurities and degradation specifications during stability testing.
Dermal Source Five-Star Vasocaine Spray and Maximum Zone Lidocaine Creams
Stability Data Does Not Support Expiry Date.
3 products
Mylan Amnesteem Isotretinoin Capsules
Amnesteem (Isotretinoin) Capsules, USP 40 mg failed dissolution specifications.
Kumho Solus TA11 Tires
Kumho Solus TA11 tires can have tread separation, increasing the risk of a crash.
2019 Audi Q8, Audi A7, and Audi A6 Vehicles
The lane departure warning system may be deactivated due to a software error, increasing the risk of a crash.
Vascutek Gelsoft Plus and Gelweave Vascular Grafts
Gelatin sealed woven polyester prostheses devices, designed for vascular repair, were incorrectly labeled with an additional month of shelf life.
Miss Vickies Spicy Dill Pickle
Miss Vickies Spicy Dill Pickle Potato Chips may contain undeclared milk, posing a risk of serious allergic reaction.
Premium Food Bubble Gum and Jordan Almonds
Premium Food Jordan Almonds contain undeclared wheat and colors, and Premium Food Bubble Gum contains undeclared colors.
2 products
Cipla Nilotinib Capsules
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
2 products
Major Pharmaceuticals Midodrine Hydrochloride Tablets
Midodrine Hydrochloride Tablets have defective containers and inadequately sealed blister packaging.
Olympus Single Use Biopsy Valve
The Olympus Single use Biopsy Valve can detach rubber fragments during use.
2 products
Datascope CS100 and CS300 Intra-Aortic Balloon Pumps
The CS100 Iabp and CS300 Iabp have battery runtime and cycle specifications that need to be updated.
2 productsSTA Liatest Free Protein S
The STA Liatest Free Protein S kit may show out-of-range results and underestimate free protein S levels in normal plasma.
Ford: Ranger, Lincoln Nautilus, Mustang, and 6 more (2025)
The exhaust gas recirculation valve may fail, causing unexpected loss of drive power and increasing crash risk.
Ford Bronco (2021-2026) and Ford Edge (2021-2024)
The rearview camera image may not display in certain Ford Bronco and Edge vehicles, reducing the driver's view and increasing crash risk.
