High Risk Recalls

IBC Technologies CX Series Combi Boilers Recalled for Burn Hazard (2025)

Abbott i-STAT CG4+ Cartridge Recall: 9,067,050 Units Across U.S. With 510(k) Clearance Issue (2025)

Lack of a 510(k) premarket clearance for the i-STAT CG4+ cartridge to reflect updated sample type for lactate and measurement ranges for pH and PO2.

Frontier Devices 301.912S1 12 mm Distraction Pin Recall Expanded to 3,790 Units (Rx Only)

Labeling includes shelf life that has not been validated.

Taylor Farms Retail Salad Kit Recalled for Undeclared Sesame and Soy Allergens (2025)

Undeclared allergens (sesame and soy).

Frontier Devices 301.914S1 Distraction Pin Recall: 10,960 Units Due to Labeling Issue

Labeling includes shelf life that has not been validated.

Medline Recalls 828 Valve Pack-LF Cannula Kits DYNJ0415366P and DYNJ0415366Q (2025)

The kits contain certain lots of cannula products where the catheter may not retain its shape.

Bard Peripheral Vascular Venclose DigiRF Generator Recall Affects 1,725 Units Worldwide

Itacate Foods CAMPSITE LENTEJAS Lentil Soup Recalled for Undeclared Yellow Dyes (154 Packages, 2025)

96 Bottles of Sulfamethoxazole and Trimethoprim Tablets Recalled for Micro-Organism Contamination

Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

Baxter Acetaminophen Injection 1000 mg/100 mL Recall for Discoloration

Baxter Healthcare’s Acetaminophen Injection 1000 mg/100 mL is recalled. The nationwide recall covers 13,000 containers with lot 24A27G66 and expiring 12/31/2025. The FDA lists discoloration as the hazard. Stop using and contact Baxter or a healthcare provider.

Itacate Foods LLC Recalls CHARGE-UP CHILAQUILES for Undeclared Yellow #5 and Yellow #6

Itacate Foods LLC recalls 566 packages of CHARGE-UP CHILAQUILES distributed to multiple U.S. states for undeclared Yellow #5 and Yellow #6 color additives. The recall is active as of September 24, 2025. No injuries are reported in the recall notice.

Carvedilol Tablets 12.5 mg Recall Expanded for NNCI Impurity Above FDA Limit (2025)

The FDA recalls 26,628 cartons of Carvedilol Tablets USP 12.5 mg distributed nationwide. The product fails CGMP standards due to NNCI impurity exceeding FDA limits. Stop using and contact The Harvard Drug Group LLC and Rugby Laboratories for guidance.

Jessie Lord Bakery Lemon Meringue Pie Recall 136,252 Cases Over Undeclared Yellow #5 (2025)

Jessie Lord Bakery is recalling 136,252 cases of Lemon Meringue Pie sold at retailers in 14 states due to undeclared Yellow #5. The dye was not disclosed on packaging. Consumers should not eat the product and should seek a refund or replacement.

Abiomed Impella Controller AIC Recall 2025 Affects 71 Units Across 6 Regions

Specific Automated Impella Controllers (AICs) that have a Pump Driver Circuit Assembly do not meet current specifications. This may lead to decreased pump performance or pump stop and trigger an Impella Failure or Impella Stopped Controller Failure alarm.

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.

Mercedes-Benz GLC 350E 4MATIC Recall for Steering Fasteners Affects 2023-2026 Models

Mercedes-Benz USA recalls 2025 GLC 350E 4MATIC and related EQE/GLC models due to a loose steering coupling bolt. The defect may loosen the steering rack, risking loss of control. Dealers will tighten bolts at no charge. MBUSA notified owners on Oct 6, 2025.

Boston Scientific Pacemaker Recall 2025 Affects ACCOLADE, ALTRUA 2 and CRT-P Devices Worldwide

Boston Scientific L221 PROPONENT DR EL Pacemaker Recalled for Safety Software Issue (2025)

Boston Scientific Pacemakers Recalled for Software Safety Issue Affecting 12,326 Units (2025)

Boston Scientific Pacemakers Recalled for Safety-Mode Initiation Software Flaw (2025)