147 recalls tagged with “mandatory standard violation”.
Claire Ellen Products recalled 72 containers of Neuroquell and Neuroquell Plus after cGMP violations were identified. The recall covers 0.22 fl oz bottles distributed online. Consumers should stop using the product immediately and contact Atlantic Management Resources Ltd. via email for guidance.
FDA enforcement lists 230 bottles of Cyclobenzaprine labeled incorrectly as Meloxicam. The labeling error was detected in a nationwide recall. Health professionals and patients should stop using the mislabeled bottles immediately. Contact Unichem Pharmaceuticals USA or a clinician for guidance.
LeMaitre Vascular recalls 10 Artegraft Collagen Vascular Grafts distributed internationally to Great Britain and Switzerland, with no US distribution. The devices were labeled incorrectly and lacked CE and UKCA marks and missing patient documents. Healthcare providers and patients should stop using the devices and follow recall instructions immediately.
CooperVision recalled 180 Softmed Breathables toric daily disposable contact lenses after one lot was manufactured with an invalid sterilization cycle. The lenses were distributed across Florida, Kentucky, North Carolina and Wisconsin. Patients should stop using the affected lenses immediately and follow the recall instructions.
Abbott Point Of Care recalled 8,962,450 i-STAT CG8+ cartridges sold nationwide in the United States. The recall stems from a lack of FDA 510(k) premarket clearance for updated sample types and measurement ranges. Healthcare providers and patients should stop using these cartridges and follow Abbott's recall instructions.
Abbott Point Of Care recalled 547,250 i-STAT CG8+, EG7+, and EG6+ cartridges distributed nationwide in the United States. The recall concerns lack of 510(k) premarket clearance for updated sample types and measurement ranges. Hospitals and clinicians should stop using these cartridges immediately and follow Abbott’s recall instructions.
Hostess recalled 60,630 cases of Ding Dongs chocolate cake due to mold contamination. A malfunctioning cooler caused the mold, leading to multiple customer complaints. Consumers should not eat the products and should contact The J.M. Smucker Company for refunds.
Boston Scientific recalls 223,163 pacemakers worldwide due to software issues affecting Safety Architecture. The recall covers ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2 DR devices and VISIONIST and VALITUDE CRT-Ps. The defect prevents initiation of Safety Mode when battery impedance is high. Patients should stop using the device and follow manufacturer instructions.
Boston Scientific recalled 190,088 pacemakers worldwide, including ACCOLADE family devices and related CRT-Ps. The software to enhance Safety Architecture could prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state. Patients and healthcare providers should stop using these devices immediately and await manufacturer instructions by letter.
Boston Scientific recalled 41,009 pacemakers worldwide after a software flaw could prevent Safety Mode activation. The defect affects devices in the ACCOLADE family and several related models. Patients and healthcare providers should stop using the device immediately and follow recall instructions from the manufacturer.
Exactech recalled 61,334 Equinoxe reverse shoulder humeral liners sold worldwide after finding the articular surface position outside labeling dimensions. The recall covers REF 320-38-00, REF 320-38-03, REF 320-42-00, and REF 320-42-03. Healthcare providers and patients should stop using the devices immediately and follow recall instructions distributed by email.
Penner Patient Care recalled 45 Penner Pacific Bathing Spa units distributed nationwide in the United States. The devices do not bear a unique device identifier. Patients and healthcare providers should stop using this device immediately and follow the recall instructions provided by the manufacturer.
Penner Patient Care, Inc. recalled 21 Penner Pacific Bathing Spa units distributed nationwide in the United States after discovering the devices do not bear a unique device identifier. The missing UDI hinders traceability for adverse events and recalls. Consumers should stop using the devices and contact Penner Patient Care for instructions.
Penner Patient Care recalled 10 Penner Pacific Bathing Spa units nationwide on 2025-08-13 after regulators flagged the device lacks a unique device identifier. The device does not bear a unique device identifier. Patients and healthcare providers should stop using the device immediately and follow the manufacturer’s recall instructions.
Siemens Medical Solutions USA is recalling 20 Artis Pheno image- intensifiied fluoroscopic X-ray systems distributed nationwide. The recall cites limited system movements after startup. Hospitals and healthcare providers should stop using the devices immediately and follow the manufacturer's recall instructions.
Max Mobility LLC recalls Permobil Smart Drive MX2+ SpeedControl Dial MX2-3DCK affecting 15,834 units sold through multiple retailers. A faulty electrical connection between the speed control dial and the wheelchair motor can cause loss of control. Stop using the device immediately and follow recall instructions; contact Max Mobility LLC or your healthcare provider for instructions. This recall was
Applied Medical Technology recalled 840 NutraGlide ENFit nasal feeding tubes distributed in the United States to Massachusetts and Rhode Island. The tubes have distal tips that may detach at lower than expected forces. Healthcare providers and patients should stop using the device immediately and follow the recall instructions.
Applied Medical Technology recalled 1,780 NutraGlide ENFit nasal feeding tubes distributed in Massachusetts and Rhode Island. Distal tips on these devices may detach at lower than expected forces. Stop using immediately and follow the recall instructions.
Hi-Tech Pharmaceuticals recalled 85,950 units of PrimeNutrition PhytoForm Fruits & Greens Formula dietary supplement on Aug. 6, 2025. The product was manufactured by Prime Nutrition and distributed nationwide. The recall cites unapproved drug claims and misbranding. Consumers should not use the product and should contact Hi-Tech Pharmaceuticals for refund or replacement.
Amazon recalled Amazon Basics Premium Foam Eurotop Mattresses sold on Amazon. The nine-inch mattresses in twin, full, queen and king sizes were manufactured from 12/22/2022 through 05/16/2024 and violate the federal flammability standard, posing a fire hazard. Stop using the recalled mattress and contact Amazon for a full refund.