Recalls published in October 2025
Everything the FDA, USDA FSIS, CPSC and NHTSA announced in October 2025, newest first.
-
Class I · 1+ years ago
Bronchofiberscope Olympus BF Type TE2 recall: Additional IFU updates to provide further clarification on safe and effective
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma…
-
Class I · 1+ years ago
Boston Scientific Corporation recall: Software to enhance Safety Architecture is available and designed to prevent
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery…
-
Class I · 1+ years ago
Abbott TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ recall: Abbott has become aware of a limited number of tip detachment events during
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
-
Class I · 1+ years ago
OES Bronchofiberscope Olympus BF Type XT40 recall: Additional IFU updates to provide further clarification on safe and effective
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma…
-
Class II · 1+ years ago
GE Medical Systems, LLC LOGIQ P10 R4.5 HD ultrasound system with system software recall: The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data
The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could…
-
Class II · 1+ years ago
American Contract Systems Inc. Medical convenience kits recall: Identified products were re-gassed (sterilized more than once) after
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection…
-
Class II · 1+ years ago
Baxter Healthcare Corporation Clearlink System Continu-Flo Solution Set, Non-Vented recall: IV sets may leak
IV sets may leak.
-
Class I · 1+ years ago
Boston Scientific Corporation recall: Software to enhance Safety Architecture is available and designed to prevent
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery…
-
Class I · 1+ years ago
Evis Exera Bronchovideoscope Olympus BF Type XT160 recall: Additional IFU updates to provide further clarification on safe and effective
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma…
-
Class I · 1+ years ago
Boston Scientific Corporation recall: Software to enhance Safety Architecture is available and designed to prevent
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery…
-
Class II · 1+ years ago
Baxter Healthcare Corporation Clearlink System Solution Set, Duo-Vent recall: IV sets may leak
IV sets may leak.
-
Class II · 1+ years ago
SV Labs Prescott Corporation Aloe Up Sport Performance Sunscreen Lotion SPF 30 recall: cGMP deviations: the firm released and distributed product which failed total
cGMP deviations: the firm released and distributed product which failed total aerobic microbial count testing.
-
Class III · 1+ years ago
Endo USA, Inc. Everolimus tablets 5mg, 28 tablets recall: Failed Impurities/Degradation Specifications: Out of specification
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
-
Class II · 1+ years ago
Glenmark Pharmaceuticals Inc., USA Viorele, Desogestrel and Ethinyl Estradiol, USP recall: Failed Impurities/Degradation Specifications
Failed Impurities/Degradation Specifications
-
Class III · 1+ years ago
STAQ Pharma, Inc. FentaNYL Citrate PF, 500mcg/50 mL in Nacl, Injection for IV use recall: Labeling: Incorrect or Missing Lot and/or Exp Date
Labeling: Incorrect or Missing Lot and/or Exp Date
-
Class III · 1+ years ago
STAQ Pharma, Inc. Hydromorphone HCL PF, 10mg/50 mL in Nacl, Injection for IV use recall: Labeling: Incorrect or Missing Lot and/or Exp Date
Labeling: Incorrect or Missing Lot and/or Exp Date
-
Class II · 1+ years ago
Ascend Laboratories, LLC Atorvastatin Calcium Tablets USP, 40 mg recall: Failed Dissolution Specifications
Failed Dissolution Specifications
-
Class II · 1+ years ago
Ascend Laboratories, LLC Atorvastatin Calcium Tablets USP, 10 mg recall: Failed Dissolution Specifications
Failed Dissolution Specifications
-
Class I · 1+ years ago
IntegraDose Compounding Services LLC Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride recall: Subpotent Drug: Testing revealed there was no oxytocin in the IV bag
Subpotent Drug: Testing revealed there was no oxytocin in the IV bag.
-
Class II · 1+ years ago
Astrazeneca Pharmaceuticals Fasenra Injection, 30 mg/mL recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility:
-
Class II · 1+ years ago
Amerisource Health Services LLC Sucralfate Tablets, USP 1 gram, 100 Tablets recall: CGMP Deviations: The recalling firm filed for Chapter 11 on September 30
CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot…
-
Class II · 1+ years ago
Ascend Laboratories, LLC Atorvastatin Calcium Tablets USP, 20 mg recall: Failed Dissolution Specifications
Failed Dissolution Specifications
-
Class III · 1+ years ago
STAQ Pharma, Inc. Ketamine Hydrochloride, 50mg/5 mL , Injection for IV use recall: Labeling: Incorrect or Missing Lot and/or Exp Date
Labeling: Incorrect or Missing Lot and/or Exp Date
-
Class II · 1+ years ago
Viona Pharmaceuticals Inc Tavaborole Topical solution 5%, 10 mL bottle recall: Discoloration
Discoloration