Medical DeviceFeb 26, 2025
KCI USA 3M Prevena Plus 125 Therapy Unit and System Kits REF: PRE3021US Prevena Plus Duo recall — FDA Z-1175-2025
Due to increase in complaints related to leak alarms
Class IIFDA: OngoingKCI USA, Inc.
February 2025 recalls — page 3
These records include useful source details for the selected month.
Medical DeviceFeb 26, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 recall — FDA Z-1154-2025
Possibility of the patient falling from the table related to the mattress used on the patient table.
Class IFDA: OngoingPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Medical DeviceFeb 26, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V Allura Xper FD20 Biplane recall — FDA Z-1145-2025
Possibility of the patient falling from the table related to the mattress used on the patient table.
Class IFDA: OngoingPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Medical DeviceFeb 26, 2025
Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OR-001 recall — FDA Z-1203-2025
Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucose alarms/alerts as designed, which can result in two different conditions. First, if a…
Class IIFDA: OngoingDexcom, Inc.
Medical DeviceFeb 26, 2025
RayStation -Intended as a Radiation Therapy Treatment Planning System recall — FDA Z-1186-2025
Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a…
Class IIFDA: OngoingRAYSEARCH LABORATORIES AB
Medical DeviceFeb 26, 2025
RayStation- Intended as a Radiation Therapy Treatment Planning System recall — FDA Z-1190-2025
Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a…
Class IIFDA: OngoingRAYSEARCH LABORATORIES AB
Medical DeviceFeb 26, 2025
remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnostic use recall — FDA Z-1201-2025
Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediately upon removal from the packaging, appearing on the blood side of the…
Class IIFDA: OngoingRemel, Inc.
Medical DeviceFeb 26, 2025
KCI USA 3M V.A.C. VIA Negative Pressure Wound Therapy System REF: VIAKIT077D01/US - V.A.C. recall — FDA Z-1176-2025
Due to increase in complaints related to leak alarms
Class IIFDA: OngoingKCI USA, Inc.
Medical DeviceFeb 26, 2025
RayStation- Intended as a Radiation Therapy Treatment Planning System recall — FDA Z-1189-2025
Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a…
Class IIFDA: OngoingRAYSEARCH LABORATORIES AB
FoodFeb 26, 2025
Apna Wholesale Paras Premium Golden Raisins recall — FDA F-0564-2025
Product contains undeclared sulfites (56.8mg/serving)
Class IFDA: TerminatedApna Wholesale Inc.
FoodFeb 26, 2025
Robin J Vos dba TS Food Packaging Bacon flavored Popcorn Seasoning packaged under the recall — FDA F-0570-2025
Undeclared allergen (soy).
Class IIFDA: TerminatedRobin J Vos dba TS Food Packaging
FoodFeb 26, 2025
NEW YORK WHOLESALE GROUP ZAARAH HERBALS brand SHATAVARI POWDER recall — FDA F-0567-2025
Product contains elevated levels of lead - 6.50 mg/kg (ppm)
Class IFDA: TerminatedNEW YORK WHOLESALE GROUP
FoodFeb 26, 2025
Jack & the Green Sprouts Alfalfa Sprouts recall — FDA F-0569-2025
Sprouts have the potential to be contaminated with Listeria monocytogenes
Class IFDA: OngoingJack & The Green Sprouts, Inc.
FoodFeb 26, 2025
Shata Traders THREE RIVERS brand TUTTI-FRUTTI recall — FDA F-0565-2025
Product contains undeclared FD&C Yellow 5 and FD&C Yellow 6.
Class IIFDA: TerminatedShata Traders Inc.
FoodFeb 26, 2025
United Natural Trading Inc. dba Woodstock Farms Wegmans, Organic Almonds Dry Roasted Salted recall — FDA F-0571-2025
Product mislabeled. The back label states Organic Cashews. The front product label states Wegmans Organic unsalted dry roasted almonds. The front label is correct label for this product.
Class IIFDA: TerminatedUnited Natural Trading Inc. dba Woodstock Farms
FoodFeb 26, 2025
Global Commodities AAHU BARAH brand SOFT PLUM recall — FDA F-0568-2025
Product contains undeclared sulfites (4.66 mg/serving).
Class IIFDA: OngoingGlobal Commodities Inc.
DrugFeb 26, 2025
Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles recall — FDA D-0241-2025
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class IIFDA: OngoingGlenmark Pharmaceuticals Inc., USA
DrugFeb 26, 2025
Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles recall — FDA D-0238-2025
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class IIFDA: OngoingGlenmark Pharmaceuticals Inc., USA
DrugFeb 26, 2025
Lorazepam Tablets, USP, 2mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs) recall — FDA D-0228-2025
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Class IIFDA: OngoingThe Harvard Drug Group LLC dba Major Pharmaceuticals…
DrugFeb 26, 2025
Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles recall — FDA D-0242-2025
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class IIFDA: OngoingGlenmark Pharmaceuticals Inc., USA
DrugFeb 26, 2025
Lorazepam Tablets, USP, 1mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs) recall — FDA D-0227-2025
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Class IIFDA: OngoingThe Harvard Drug Group LLC dba Major Pharmaceuticals…
DrugFeb 26, 2025
Silodosin Capsules, 8mg, 90-count bottle recall — FDA D-0229-2025
Subpotent Drug: Out of Specification (OOS) result for De hydro Impurity (0.654%) for 18 M Stability sample and low assay 94.9% (specification of NLT 95.0% NMT 105%)
Class IIFDA: OngoingAvKARE
DrugFeb 26, 2025
Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles recall — FDA D-0243-2025
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class IIFDA: OngoingGlenmark Pharmaceuticals Inc., USA
DrugFeb 26, 2025
Fentanyl Transdermal System CII, 25mcg/h recall — FDA D-0245-2025
Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
Class IFDA: OngoingAlvogen, Inc
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.