mandatory standard violation Recalls

Generic Magnetic Ball Sets Recalled for Magnet Ingestion Risk Sold on Amazon by Ritons (2025 recall)

Bellabu Bear Recalls Bamboo Sherpa Children's Robes for Burn Hazard (2025)

Pivotal Health Solutions Recalls 34 Quantum Q400 Heated Massage Tables for Overheating Risk (2025)

The heat function may become damaged over time due to patients pressing on the areas with heat function components. Damage to components can lead to overheating which can lead to smoldering and melting of the vinyl cushion.

Blossom Recalling 2-Piece Children’s Loungewear for Burn Risk in 2025 Recall

Wegmans Recalls 521 Units of Large Ultimate Plain Cheesecake for Undeclared Pecans (2025)

Synthes 5.0mm IM Nail Locking Screws Recalled for Packaging Length Label Error (120 Units, 2025)

Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46mm screws were packaged and labeled as 42mm.

Mad Rabbit RELIEVE Lidocaine Numbing Cream Recalled for Non‑Child-Resistant Packaging

BD Recalls 62 BD MAX System IVD Units Worldwide Over Credential Breach (2025)

Kico Knee Innovation ARVIS Shoulder AI Planning Software Recalled for High-Risk Malalignment in 21-0

Complaint identified issue with AI surgical planning software that may result in implant malalignment and/or decrease range of motion.

Ascend Laboratories Recalls Alkem Atorvastatin Calcium 20 mg Tablets for Dissolution Failures (3 NDC

GE Medical Systems LOGIQ P9 R4.5 Ultrasound System Recalled for Inaccurate Liver Readings (37 Units)

The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care.

B. Braun Medical Recalls 5,770 PERIFIX FX Epidural Anesthesia Trays for Lid Position Issue

Potential for the lid of the catheter connector to be in the incorrect position.

B Braun Medical Recall Expands for Perifix FX Epidural Tray and Catheter Over Lid Position Defect (Z

Potential for the lid of the catheter connector to be in the incorrect position.

GE Medical Systems Israel Recalls 11 Elscint Cardial Gamma Cameras in 2025

In My Jammers Recalls Button Flare Pajama Sets for Burn Hazard in 2025

Olympus BF-1T60 Bronchofiberscope Recall for IFU Updates (2025)

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

Beckman Coulter MicroScan Neg Multidrug Resistant MIC 1 C32368 Recall Expands Internationally (2025)

Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test.

American Contract Systems Recalls 32,433 Medical Convenience Kits Over Re-Gassing Risk (2025)

Zydus Lifesciences Chlorpromazine Hydrochloride 25 mg 100-count Tablets Recalled Nationwide (2025)

CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit

Siemens MRI Recall: 18 MAGNETOM Skyra Fit BioMatrix Systems Recalled Over Helium Vent Blockage Risk