Health & Personal Care
HIGH
FDA DRUG
Claire Ellen Products Neuroquell & Neuroquell Plus Recall: 72 Containers in 2025
Claire Ellen Products
cGMP violations
mandatory standard violation Recalls
147 recalls tagged with “mandatory standard violation”.
Health & Personal Care
HIGH
FDA DRUG
Unichem Pharmaceuticals USA Cyclobenzaprine Recall for Label Mix-Up Affects 230 Bottles (2025)
Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in color).
CYCLOBENZAPRINE HYDROCHLORIDE
Labeling: Label
Health & Personal Care
HIGH
FDA DEVICE
LeMaitre Vascular Artegraft 10-Unit Recall 2025 for Labeling Errors
Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.
LeMaitre Vascular
Devices were
Health & Personal Care
HIGH
FDA DEVICE
CooperVision Recalls 180 Softmed Breathables Toric Lenses Over Invalid Sterilization Cycle (2025)
One lot manufactured with an invalid sterilization cycle.
CooperVision
One lot
Health & Personal Care
HIGH
FDA DEVICE
Abbott i-STAT CG8+ Cartridge Recall 2025: 8,962,450 Units
Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2.
Abbott Point Of Care
Lack of
Health & Personal Care
HIGH
FDA DEVICE
Abbott i-STAT CG8+, EG7+, EG6+ Cartridges Recalled in 2025 Over Missing 510(k) Clearance
Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2.
Abbott Point Of Care
Lack of
Food & Beverages
HIGH
FDA FOOD
60,630 Hostess Ding Dongs Recalled for Mold Risk — Check Your Best If Use By Dates
Mold. The firm noticed an increase in customer complaints. They conducted a root cause investigation and discovered that one of their coolers had malfunctioning.
The J.M. Smucker
Mold. The
Health & Personal Care
HIGH
FDA DEVICE
Boston Scientific Pacemakers Recalled Over Software Flaw in Safety Architecture (2025)
Boston Scientific
Software to
Health & Personal Care
HIGH
FDA DEVICE
Boston Scientific ESSENTIO DR EL MRI Pacemaker Recalled for Software Safety Issue (190,088 Units, 0)
Boston Scientific
Software to
Health & Personal Care
HIGH
FDA DEVICE
Boston Scientific Pacemakers Recalled for Safety Architecture Software Issue (41,009 Units, 2025)
Boston Scientific
Software to
Health & Personal Care
HIGH
FDA DEVICE
Exactech Equinoxe 61,334 Reverse Shoulder Humeral Liners Recalled Worldwide (2025)
Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
Exactech
Reverse Shoulder
Health & Personal Care
HIGH
FDA DEVICE
Penner Patient Care Bathing Spa Recalled for Missing UDI in 2025
The device does not bear a unique device identifier.
Penner Patient Care
The device
Health & Personal Care
HIGH
FDA DEVICE
Penner Patient Care's Penner Pacific Bathing Spa Recalled for Missing UDI in 21 Units (2025)
The device does not bear a unique device identifier.
Penner Patient Care
The device
Health & Personal Care
HIGH
FDA DEVICE
Penner Pacific Bathing Spa Recall: 10 Units Missing UDI (2025)
The device does not bear a unique device identifier.
Penner Patient Care
The device
Health & Personal Care
HIGH
FDA DEVICE
Siemens Artis Pheno Fluoroscopic X-Ray System Recalled for 20 Units in 2025
Limited system movements after startup .
Siemens Medical Solutions USA
Limited system
Health & Personal Care
HIGH
FDA DEVICE
Max Mobility Permobil MX2+ SpeedControl Dial Recalled for 15,834 Units in 2025
Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, their is a potential for lost of control of the device potentially resulting in minor or major injuries.
Max Mobility
Due to
Health & Personal Care
HIGH
FDA DEVICE
Applied Medical Technology NutraGlide ENFit Nasal Feeding Tube Recall 840 Units (2025)
The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.
Applied Medical Technology
The nasal
Health & Personal Care
HIGH
FDA DEVICE
Applied Medical Technology Recalls NutraGlide ENFit Nasal Feeding Tube 5F-6F x 55 in (1,780 units)
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.
Applied Medical Technology
The nasal
Food & Beverages
HIGH
FDA FOOD
Hi-Tech Pharmaceuticals Recalls PrimeNutrition PhytoForm Fruits & Greens Formula 30 Servings for Unf
Unapproved Drug Claims and Misbranded.
Hi-Tech Pharmaceuticals
Unapproved Drug
HIGH
CPSC
Amazon Recalls Amazon Basics Premium Foam Eurotop Mattress for Fire Hazard (2025)
Amazon
The recalled