cpsc regulated Recalls

Gina Marie Bakery Recall: 172 Cases of Vanilla Chocolate Dipped Cookies Recalled for Undeclared Red

Gina Marie Bakery Italian Sesame Cookies Recalled for Undeclared Sesame and Food Colorings (2025)

Undeclared Sesame, Undeclared Yellow 5, Red 40, Yellow 6

Abbott TactiFlex Ablation Catheter Recalled for Tip Detachment Risk (11,805 units, 2025)

Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.

Biomet Juggerknot Mini Soft Anchors 912080 Recall 40 Units Nationwide 2025

The outer carton box label is for the JuggerKnot 1.0mm Mini products. However, the products within the carton are JuggerKnot 1.4mm Short devices.

BioPro Recalls 147 Bipolar Heads Over Sterility Risk — Check Your Model Numbers

Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.

Whole Foods Market Granola Recalled for Undeclared Allergens in 6-Unit Pack

Product was incorrectly labeled, resulting in undeclared wheat, sesame, and cashew.

Hale Fresh Basil Infused Olive Oil Recall: 54 Bottles in Kentucky (2025)

Potential to be contaminated with Clostridium botulinum. Products manufactured without an approved process filed.

BioPro Endo Head Ceramic Recall Affects 147 Units Over Sterility Packaging Issue (2025)

Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.

Draeger Atlan A350XL Anesthesia Workstation Recalled for Ventilator Failure Risk (223 Units) in 25+N

The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.

BioPro Recalls 147 Metal and Ceramic Femoral Heads Over Sterility Packaging Issue

Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.

MedicalCommunications GmbH Recalls 474 Ashvins HEYEX 2 / HEYEX PACS Software Units (2025)

Potential that the measured value may be smaller than the actual area.

BioPro Femoral Head Hip Implant Recall 147 Units in 2025 Texas and Michigan

Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.

Lee K of NY Inc. Recalls 43-Unit Batch of PINOCCHIO CATERING Aged Kimchi Mackerel for Undeclared All

Product contains undeclared milk and shrimp

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.

Iantrek CycloPen CP-300 Cyclodialysis System Recalled for Sterile Packaging Integrity (2025)

Potential for compromised integrity of the sterile packaging.

Iantrek C-Rex UNO CRX-120 Goniotomy Instrument Recalled for Packaging Integrity Issue (2025)

Potential for compromised integrity of the sterile packaging.

Sandoz Cyclophosphamide Injection 500 mg/5 mL Recalled for Temperature Excursion During Transport

cGMP deviations: Temperature excursion during transportation.

Philips Ultrasound OMNI III TEE Transducer Recall for Labelling Clarification (75 Units) 2025

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

GE Healthcare CSCS V3 MAS800 Central Station Recalled for 2,306 Units Worldwide (2025)

Philips Ultrasound X3-1 Transducer Recalled for Labeling Clarification in 2026 (17 Units)

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.