Calcium Gluconate 2.5% solution for inhalation, 5mL pre-filled syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Pine Pharmaceuticals
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility
All Recalls
95,018 total recalls in our database
Vancomycin 1 MG/0.1 ML Solution for Intraocular Injection, 0.8 ML Single Dose Vial, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Pine Pharmaceuticals
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility
Tropi-Phen (tropicamide 1%, phenylephrine 2.5%) ophthalmic solution, 5mL multi-use dropper, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Pine Pharmaceuticals
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility
Bevacizumab 1.25 MG/0.05 ML Solution for Injection, 1 mL syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Pine Pharmaceuticals
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility
Endophth Kit (Vancomycin 1mg/0.1 mL - Ceftazidime 2.25mg/0.1 mL), Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Pine Pharmaceuticals
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility
Foscarnet Sodium 2.4mg/0.1 mL solution for injection, 0.2 mL single-dose Staclear Luer Slip Syringe, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Pine Pharmaceuticals
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility
Tropi-Phen (Tropicamide 1% phenylephrine HCl 2.5%) ophthalmic solution, 15 mL multi-use Droppers, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Pine Pharmaceuticals
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility
💊 Drugs Class I - Dangerous
Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.
Certain Over-The-Counter (OTC) drug products sold by Family Dollar retail stores.
Dollar Tree Distribution
💊 Drugs Class I - Dangerous
CGMP Deviations: OTC products were stored outside of labeled temperature requirements.
Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
There have been reports of patients suffering arrhythmias, reported as short cardiac arrests, during surgical procedures where UHI-4s were used. These events may have been due to an over insufflation of the abdominal cavity resulting from use of the UHI-4 during the procedures.
SenSight Connector Plug, Model Number B31061.
Medtronic Neuromodulation
🏥 Medical Devices Class I - Dangerous
Medtronic is requesting return of a small number of units of the SenSight Connector Plug, Model B31061, due to a discrepancy in the Use By Date (UBD) printed on the label.
🏥 Medical Devices Class I - Dangerous
One lot of Tournier Perform Reversed Lateralized Baseplates were found to have been manufactured with 6mm spacers instead of 3mm spacers. This nonconformance prevents the central screw from being able to thread into the baseplate.
🏥 Medical Devices Class I - Dangerous
Infusion Pumps with affected software revision may fail to detect air in line, which may lead to air embolism.
Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Product Code: 1180100777
Cardinal Health 200
🏥 Medical Devices Class I - Dangerous
Syringe contains conical tip that is not compatible with certain needleless IV connector(s).
MEDLINE ReNewal Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/ GEN11 SW v2018-1 and Lower, REF HARH45R. surgical instrument.
MEDLINE INDUSTRIES, LP - Northfield
🏥 Medical Devices Class I - Dangerous
Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray.
MEDLINE ReNewal Ligasure Maryland Jaw Sealer/Divider Nano-Coated Complatible with FT10 Generator, REF LF1944CR. electrosurgical instrument
MEDLINE INDUSTRIES, LP - Northfield
🏥 Medical Devices Class I - Dangerous
Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray.
🏥 Medical Devices Class I - Dangerous
Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorrect revision of the Instructions For Use (IFU) which do not include the following warnings statement: HydroPICC Dual Lumen Catheter is for adult use only. There is a potential risk to health should the HydroPICC Dual Lumen Catheter be used in an inadequately sized vessel. There have been no reported adverse events to date.
🏥 Medical Devices Class I - Dangerous
Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorrect revision of the Instructions For Use (IFU) which do not include the following warnings statement: HydroPICC Dual Lumen Catheter is for adult use only. There is a potential risk to health should the HydroPICC Dual Lumen Catheter be used in an inadequately sized vessel. There have been no reported adverse events to date.
Functional MR V1.0
OLEA MEDICAL
🏥 Medical Devices Class I - Dangerous
When exporting regions of interest in DICOM SEGMENTATION format, when simultaneously exporting multiple volumes of interest, a functional magnetic resonance software bug may cause file contents and associated series descriptions to not match, which could lead to a misinterpretation of clinical data.
DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit
DeRoyal Industries
🏥 Medical Devices Class I - Dangerous
DeRoyal is recalling certain lots of surgical procedure pack products that contain the B.Braun Medical Norm-Ject 2 Piece Syringe. The recall is due to the potential for the sterile packaging barrier to be damaged due to damage to the luer tip of the syringe.