1,319 recalls tagged with “fda regulated”.
Aesculap recalls 126 MINOP TROCAR 150MM devices distributed nationwide to U.S. hospitals and clinics after regulators flagged a shaft length issue. The shaft may be longer than specified, potentially harming tissue during procedures. Healthcare facilities should stop using the devices and follow manufacturer recall instructions immediately.
Edermy LLC recalled the PIE Trolley System Model 2005 on January 14, 2026 due to a lack of 510K clearance. The recall affects 27 units distributed nationwide across 15 states. Users must stop using the device and follow the manufacturer's instructions immediately.
Sevillo Fine Foods recalled 2,372 units of Slow Roasted Diced Tomatoes distributed to California and North Carolina. The product may contain metal fragments. Consumers should not consume the product and should contact Sevillo Fine Foods for refunds or replacements.
Sevillo Fine Foods recalled 520 units of Slow Roasted Diced Tomatoes distributed to California and North Carolina after the product may contain metal fragments. The product is frozen and packaged in bulk with a plastic liner inside a cardboard box. Consumers should not eat the product and should contact Sevillo Fine Foods for refund or replacement via email.
Rose and Shore recalled 5,067.1 cases of 14" Margarita Thin Crust Pizza sold at a single regional chain in California, Oregon, Arizona, Idaho and Texas. A potential foreign object has been found in tomatoes used in the product. Consumers should not eat this pizza and should contact Rose and Shore for refund or replacement by email.
Waldemar Link GmbH & Co. KG recalled 2 units of Endo-Model Replacement Plateau with Item Number 15-0027/11. The defect could cause the bushing to detach from the screw shaft after a longitudinal fracture. Health care providers and patients should stop using the device and await manufacturer instructions.
Waldemar Link GmbH & Co. KG recalls its Endo-Model Replacement Plateau implant. Three units are affected worldwide, including New Jersey in the United States. The defect allows a bushing to detach from the screw shaft after a longitudinal fracture. Healthcare providers and patients should stop using the device immediately and follow the manufacturer’s recall instructions. Notification was sent by,
Waldemar Link recalled 44 Endo-Model SL implant components sold through multiple distributors worldwide, including 1 unit in the United States. The bushing could detach from the screw shaft because of a longitudinal fracture. Healthcare providers and patients should stop using the device immediately and follow recall instructions from Waldemar Link for returns or replacements.
Teva Pharmaceuticals USA, Inc. recalls 8,376 isotretinoin 40 mg capsules distributed to FL, OH, PR and MS after FDA enforcement report flags superpotent and subpotent lots. Patients should stop use and contact their healthcare providers for guidance.
Waldemar Link recalled 3 Endo-Model Replacement Plateau implants distributed worldwide, including New Jersey. The devices carry a risk that a bushing could detach from the plateau screw shaft due to a longitudinal fracture. Healthcare providers and patients should stop using the device immediately and follow manufacturer recall instructions.
Waldemar Link GmbH & Co. KG recalled 4 Endo-Model Replacement Plateau devices, Item Number 15-8030/12, sold to hospitals and clinics worldwide including New Jersey. The defect involves a plateau screw, where a longitudinal fracture could cause the bushing to detach from the screw shaft. Healthcare providers and patients should stop using the device immediately and follow recall instructions from/
Waldemar Link recalled 1 unit of Endo-Model Replacement Plateau implant component distributed worldwide, including New Jersey. The defect involves a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. Patients and healthcare providers should stop using the device immediately and follow the manufacturer’s recall instructions.
Waldemar Link recalled 1 unit of Endo-Model Replacement Plateau worldwide, including the United States in New Jersey. The device could detach its bushing from the screw shaft because of a longitudinal fracture. Clinicians and patients should stop using the device and await manufacturer instructions.
Teva Pharmaceuticals USA, Inc. recalls 21,984 packages of Isotretinoin Capsules, USP, 30 mg. The lots are distributed to Florida, Ohio, Puerto Rico and Mississippi. The recall is active as of April 15, 2026.
Waldemar Link recalled 31 Endo-Model SL Connection Components incl. PE-Plateau sold worldwide, including New Jersey. The device bears a risk that the bushing could detach from the screw shaft due to a longitudinal fracture. Clinicians and patients should stop using the device immediately and follow manufacturer instructions.
Waldemar Link recalled 7 Endo-Model Replacement Plateau devices distributed worldwide, including New Jersey. The recall targets an implant component where a bushing could detach from the screw shaft after a longitudinal fracture. Healthcare providers and patients should stop using the device and follow recall instructions provided by the manufacturer.
Diva Fam Inc recalled 5,438,998 jars of Sea Moss Gel on January 9, 2026. The product may be contaminated with Clostridium botulinum, posing serious health risks. Consumers should not consume the product and seek refunds immediately.
Medartis AG recalls 126 APTUS 2.8 TriLock Screws 16mm HD7 worldwide. The mix-up between 2.5mm and 2.8mm outer diameter screws could affect fixation. Stop using the device and follow manufacturer recall instructions for disposition.
Medartis AG recalled the 2.5 TriLock Screw 16mm HD7, 1/Pkg, sold worldwide through medical distributors including the US states of Indiana and Pennsylvania. The recall stems from a mix-up between 2.5mm and 2.8mm outer diameter screws. Healthcare providers and patients should stop using the device immediately and follow manufacturer recall instructions.
Medline Industries recalled 31,848 dialysis dressing change kits on January 8, 2026. The recall follows reports of defective silicone seals on Tego Connectors that may occlude fluid paths. This defect can delay therapy and expose patients to biological contaminants.