💊 Drugs Class I - Dangerous
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
All Recalls
95,018 total recalls in our database
Travoprost Ophthalmic Solution, USP (Ionic Buffered Solution), 0.004%, Rx only, Manufactured by Apotex Inc., Manufactured by: GSMS Incorporated, Camarillo, CA 93012, a) NDC 51407-731-25 (2.5 mL bottle), b) NDC 51407-731-05 (5 mL bottle).
Golden State Medical Supply
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility: Tamper Evidence Seal is missing on secondary container.
GLYCOPYRROLATE INJECTION, USP 0.2MG/ML, 1mL VIAL, manufactured by HF Acquisition Co. LLC, Mukilteo, WA 98275, NDC 51662-1487-3
HF Acquisition Co
💊 Drugs Class I - Dangerous
Labeling: Label Mix-up
🏥 Medical Devices Class I - Dangerous
Some of the ambIT kits were potentially distributed without an air in-line filter.
Alinity i Anti-TPO Reagent Kit, List Number 09P3521
Abbott Ireland Limited
🏥 Medical Devices Class I - Dangerous
Due to a manufacturing fill volume error, Alinity i Anti-TPO Reagent contains a marginally lower fill volume than detailed in the Kit Contents section of the Instructions for Use (IFU).
🏥 Medical Devices Class I - Dangerous
Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or flow. A malfunction caused by this issue can result in patient harm up to hypoxemia if not addressed by the care provider.
🏥 Medical Devices Class I - Dangerous
Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impact product sterility.
🏥 Medical Devices Class I - Dangerous
IFU- Instructions for Use (IFU) package insert and both the IFU packaged with the test kit and the electronic version on the BD website not approved by FDA,specifically describing specimen type, could cause use of the test with invalid specimen types, which may produce false positive or false negative results.Erroneous results can cause a delay in diagnosis or treatment
🏥 Medical Devices Class I - Dangerous
The custom procedure packs contain light handle covers that have been recalled by another firm.
Potential for the incorrect size stent-graft than the printed carton label.
SMMT ambIT Kit Basic Filter Luer Cass, Product Code: 220537
Avanos Medical
🏥 Medical Devices Class I - Dangerous
Some of the ambIT kits were potentially distributed without an air in-line filter.
🏥 Medical Devices Class I - Dangerous
QRR049001 Lot QCAB6AN505 incorrectly labelled as QRR049002 Lot QCAB6AAA28. The incorrectly labelled vial will upload the range for the Starrsed Control Level A and the instrument result will be flagged as out of range.
DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212725
DePuy Mitek, Inc., a Johnson & Johnson
🏥 Medical Devices Class I - Dangerous
IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS¿ Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery time
🏥 Medical Devices Class I - Dangerous
Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impact product sterility.
DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212726
DePuy Mitek, Inc., a Johnson & Johnson
🏥 Medical Devices Class I - Dangerous
IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS¿ Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery time
🏥 Medical Devices Class I - Dangerous
Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or flow. A malfunction caused by this issue can result in patient harm up to hypoxemia if not addressed by the care provider.
Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for Laparoscopic surgery
Cardinal Health 200
🏥 Medical Devices Class I - Dangerous
Inadvertently released for distibution without sterility assurance.
DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212722
DePuy Mitek, Inc., a Johnson & Johnson
🏥 Medical Devices Class I - Dangerous
IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS¿ Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery time
StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems
Medtronic Navigation
🏥 Medical Devices Class I - Dangerous
During non-axial/some axial exams, software anomalies occur during procedures affecting depth gauge graphic displays for cranial biopsy; causing displays to no longer synchronize with other navigational information showing inaccurate values, which may result in prolonged/additional procedure, tissue injury
ambIT Cassette Filter Male Luer, Product Code: 220266
Avanos Medical
🏥 Medical Devices Class I - Dangerous
Some of the ambIT kits were potentially distributed without an air in-line filter.