Frontier Devices 301.916S1 16 mm Distraction Pin Recall Expanded (2025)
Labeling includes shelf life that has not been validated.
2,143 recalls tagged with “cpsc regulated”.
Labeling includes shelf life that has not been validated.
Labeling includes shelf life that has not been validated.
Labeling includes shelf life that has not been validated.
Labeling includes shelf life that has not been validated.

Labeling includes shelf life that has not been validated.
Labeling includes shelf life that has not been validated.
Undeclared allergens (sesame and soy).
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.
Product contains undeclared Soy and Sesame
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.
The kits contain certain lots of cannula products where the catheter may not retain its shape.
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.
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.
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.
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.
Mold. The firm noticed an increase in customer complaints. They conducted a root cause investigation and discovered that one of their coolers had malfunctioning.
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.