💊 Drugs Class I - Dangerous
Lack of assurance of sterility.
All Recalls
95,102 total recalls in our database
Testosterone Cypionate 200 mg/mL in Sesame Oil, Packaged in a) 5 mL Multi-Dose vial NDC, 73198-0055-05; b) 10 mL Multi-Dose vial NDC 73198-0055-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835.
Olympia Compounding Pharmacy
💊 Drugs Class I - Dangerous
Lack of assurance of sterility.
NAD+ Nicotinamide Adenine Dinucleotide, Lyophilized powder for reconstitution, Multi-Dose 500 mg per vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0083-00.
Olympia Compounding Pharmacy
💊 Drugs Class I - Dangerous
Lack of assurance of sterility.
💊 Drugs Class I - Dangerous
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
Zinc Chloride (0.5 mg/mL), Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0071-30
Olympia Compounding Pharmacy
💊 Drugs Class I - Dangerous
Lack of assurance of sterility.
💊 Drugs Class I - Dangerous
Lack of assurance of sterility.
Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5 mg, Pkg Size: 30, NDC: 68788-7758-03.
Preferred Pharmaceuticals
💊 Drugs Class I - Dangerous
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Sermorelin Acetate Lyophilized powder for reconstitution 9 mg Per Multi-Dose Vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0059-00
Olympia Compounding Pharmacy
💊 Drugs Class I - Dangerous
Lack of assurance of sterility.
🏥 Medical Devices Class I - Dangerous
Inner pouch seal may be inadequate resulting in lack of sterility.
🏥 Medical Devices Class I - Dangerous
Firm received 10 complaints of skin barrier delamination issues (e.g. flange lifts from wafer, skin barrier layers separate) or tape border rips/tears.
Vanta INS Implantable Neurostimulator. Medtronic Model 977006 Vanta with AdaptiveStim Technology Neurostimulator with Surescan MRI technology, part of a neurostimulator system for pain therapy.
Medtronic Neuromodulation
🏥 Medical Devices Class I - Dangerous
The Implantable Neurostimulator Model may be susceptible to not communicating with the clinical programmer and/or patient programmer system.
🏥 Medical Devices Class I - Dangerous
There is a potential hazard of uninterrupted motion of the Motorized Wheel System due to the possible failure of a component in the electrical system of the Product.
KWIK-STIK" plus: Clostridium perfringens
Microbiologics
🏥 Medical Devices Class I - Dangerous
Labeling error.
Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is placed in a plastic tray with a snap on plastic lid, the tray is placed in protective wrap, then into a sterile pouch, 1 device per carton, 1 carton per box.
Medtronic Perfusion Systems
🏥 Medical Devices Class I - Dangerous
Firm detected an increase in complaints related to fractured jaw tips of the Cardioblate Gemini-s.
🏥 Medical Devices Class I - Dangerous
Reports received of torn corrugated breathing tubes.
Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200
Medtronic Neuromodulation
🏥 Medical Devices Class I - Dangerous
The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system.
🏥 Medical Devices Class I - Dangerous
The battery wiring harness on affected wheelchairs may become disconnected during shipment from the factory or during wheelchair use traversing large obstacles or after a jolt or impact to the wheelchair. The disconnection of the battery harness results in loss of power to the wheelchair.
HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4
Devicor Medical Products
🏥 Medical Devices Class I - Dangerous
Small patient labels do not match the primary device label. The primary device label accurately identifies the product as 4010-05-08-T4, while the smaller patient label incorrectly identifies the product as 4010-05-08-T3.
Surgical Suture Kit
Stradis Healthcare
🏥 Medical Devices Class I - Dangerous
There is uncertainty about the integrity of the methods used to ensure the sterile barrier integrity.
Percept BrainSense Implantable Neurostimulator (INS), Model B35200
Medtronic Neuromodulation
🏥 Medical Devices Class I - Dangerous
The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system.