DrugFeb 26, 2025
Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles recall — FDA D-0240-2025
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class IIFDA: OngoingGlenmark Pharmaceuticals Inc., USA
February 2025 recalls — page 4
These records include useful source details for the selected month.
DrugFeb 26, 2025
Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles recall — FDA D-0244-2025
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, 18 mg, 30 capsule bottles recall — FDA D-0239-2025
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, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs) recall — FDA D-0226-2025
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…
VehicleFeb 21, 2025
X3 30 xDrive cables recall — NHTSA campaign 25V109000
BMW of North America, LLC (BMW) is recalling certain 2025 X3 30 xDrive vehicles. The connection between the positive battery cable and the starter-generator may have been improperly…
cablesBMW of North America, LLC
VehicleFeb 20, 2025
BMW lock recall — NHTSA campaign 25V106000
BMW of North America, LLC (BMW) is recalling certain 2022-2024 X3 sDrive30i and X3 xDrive30i vehicles. The second-row seat side door locking modules may not function properly and allow the…
lockBMW of North America, LLC
Medical DeviceFeb 19, 2025
CareFusion 303 BD Pyxis MedStation Auxiliary ES REF: 324 recall — FDA Z-1123-2025
Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures of the medication cabinet which could result in delay in accessing medications.
Class IIFDA: OngoingCareFusion 303, Inc.
Medical DeviceFeb 19, 2025
Exactech Alteon XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM recall — FDA Z-1167-2025
Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
Class IIFDA: OngoingExactech, Inc.
Medical DeviceFeb 19, 2025
Sertera Biopsy Device recall — FDA Z-1170-2025
Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement.
Class IIFDA: OngoingHologic, Inc.
Medical DeviceFeb 19, 2025
Cardinal Health Presource Kits: 1) OPHTHALMOLOGY ENDO DCR XTRS PK recall — FDA Z-1136-2025
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Class IIFDA: OngoingCardinal Health 200, LLC
Medical DeviceFeb 19, 2025
CareFusion 303 BD Pyxis MedStation ES (Med ES Main) REF: 323 recall — FDA Z-1122-2025
Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures of the medication cabinet which could result in delay in accessing medications.
Class IIFDA: OngoingCareFusion 303, Inc.
Medical DeviceFeb 19, 2025
Cardinal Health Presource Kits: 1) KIT,NEURO LAMI,MD ANDERSON recall — FDA Z-1127-2025
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Class IIFDA: OngoingCardinal Health 200, LLC
Medical DeviceFeb 19, 2025
CareFusion 303 BD Pyxis MedStation Auxiliary 4000 REF: 306 recall — FDA Z-1124-2025
Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures of the medication cabinet which could result in delay in accessing medications.
Class IIFDA: OngoingCareFusion 303, Inc.
Medical DeviceFeb 19, 2025
Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 1 recall — FDA Z-1134-2025
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Class IIFDA: OngoingCardinal Health 200, LLC
Medical DeviceFeb 19, 2025
CareFusion 303 (1) BD Pyxis MedStation ES, Catalog No. 323 recall — FDA Z-1120-2025
Labeling is insufficient regarding delays in access to medication. The firm is strengthening the label as an additional risk mitigation.
Class IIFDA: OngoingCareFusion 303, Inc.
Medical DeviceFeb 19, 2025
Cardinal Health Presource Kits: 1) CHI STD SPINE OPTION 1 recall — FDA Z-1135-2025
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Class IIFDA: OngoingCardinal Health 200, LLC
Medical DeviceFeb 19, 2025
Ithera Medical Gmbh The MSOT Acuity Echo is a Class 4 medical laser device recall — FDA Z-1100-2025
The MSOT Acuity Echo does not include an adequate instruction for safe operation of the device. The previous version of the user manuals contained a wrong value for the Nominal Ocular…
Class IIFDA: OngoingIthera Medical Gmbh
Medical DeviceFeb 19, 2025
Max Mobility recall — FDA Z-1117-2025
Due to faulty circuit board in speed control remote use in conjunction with a wheelchair power assist, their is a potential for lost of control of device potentially resulting in minor and…
Class IFDA: OngoingMax Mobility LLC
Medical DeviceFeb 19, 2025
Cardinal Health Presource Kits: 1) KIT,MAXILLOFACIAL,PRESBYTERIAN recall — FDA Z-1130-2025
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Class IIFDA: OngoingCardinal Health 200, LLC
Medical DeviceFeb 19, 2025
Exactech Novation XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM recall — FDA Z-1166-2025
Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
Class IIFDA: OngoingExactech, Inc.
Medical DeviceFeb 19, 2025
Getinge Usa Sales Vaporizer Sevoflurane, Quik-Fil recall — FDA Z-1074-2025
Sevoflurane used with the vaporizer may degrade to hydrogen fluoride, which could present a risk to patients or health care providers through inhalation and/or skin exposure. Potential…
Class IFDA: OngoingGetinge Usa Sales Inc.
Medical DeviceFeb 19, 2025
Cardinal Health Presource Kits: 1) KIT, CAROTID ENDARTERECTOMY recall — FDA Z-1129-2025
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Class IIFDA: OngoingCardinal Health 200, LLC
Medical DeviceFeb 19, 2025
Cardinal Health Presource Kits: 1) KIT,ROBOTIC HYSTERECTOMY recall — FDA Z-1133-2025
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Class IIFDA: OngoingCardinal Health 200, LLC
Medical DeviceFeb 19, 2025
HF Acquisition Co Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item recall — FDA Z-1141-2025
Spore test strip monitoring system, designed for routine monitoring of sterilization processes, may have a printing error on the return envelope that may cause spore test results to be…
Class IIFDA: OngoingHF Acquisition Co LLC
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.