💊 Drugs Class I - Dangerous
CGMP Deviations: recalling drug products following an FDA inspection.
All Recalls
95,018 total recalls in our database
CGMP Deviations: recalling drug products following an FDA inspection.
💊 Drugs Class I - Dangerous
CGMP Deviations: recalling drug products following an FDA inspection.
💊 Drugs Class I - Dangerous
CGMP Deviations: recalling drug products following an FDA inspection.
💊 Drugs Class I - Dangerous
CGMP Deviations: recalling drug products following an FDA inspection.
💊 Drugs Class I - Dangerous
CGMP Deviations: recalling drug products following an FDA inspection.
Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-301-10.
Nephron Sterile Compounding Center
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility
💊 Drugs Class I - Dangerous
CGMP Deviations: recalling drug products following an FDA inspection.
💊 Drugs Class I - Dangerous
CGMP Deviations: recalling drug products following an FDA inspection.
🏥 Medical Devices Class I - Dangerous
Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards, with IP addresses from x.x.x.224 to x.x.x.255
CareFusion 303
🏥 Medical Devices Class I - Dangerous
Infusion pump PCs with specific software/network cards/IP addresses can have network/wireless connection failure. Could cause inability to receive new datasets and inability to transfer retrospective analytics data to connected systems. Users with interfaces to electronic medication record or admin discharge transfer, may be unable to receive/send data; infusions may need to be manually programmed
🏥 Medical Devices Class I - Dangerous
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 40241425, Bone fixation device
Wright Medical Technology
🏥 Medical Devices Class I - Dangerous
Stryker has identified an issue that impacts two specific lots of CLAW" II plates. The plates within these two lots were found to have been comingled, resulting in the incorrect product in packages. Packaging for 402S0425 incorrectly contained 40241425, and vice versa.
Custom Suture Pack Product Description: US1638 CUSTOM SUTURE PACK US1756 CUSTOM SUTURE PACK
Covidien
🏥 Medical Devices Class I - Dangerous
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
🏥 Medical Devices Class I - Dangerous
Firm has initiated a removal of the product due to insufficient evidence of packaging sterility. Exposure to a non-sterile medical device may result in inflammation, infection, sepsis, or ischemia.
Life2000 Ventilator PKG, Hospital, a) REF BT200011, b) REF BT-20-0011, ventilatory support for the care of individuals
Baxter Healthcare
🏥 Medical Devices Class I - Dangerous
There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.
Triton Canister Software Catalog Number: GAUS-2. Intended adjunct in the estimation of blood loss.
Stryker
🏥 Medical Devices Class I - Dangerous
Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output inaccurate blood loss estimates can lead to confusion and could potentially result in either delayed recognition or prolongation of postpartum hemorrhage (PPH), or require more aggressive treatment for PPH.
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
MultiLab Series II ROODRA non-invasive vascular diagnostic device, Model Number 11986-0000-01
Unetixs Vascular
🏥 Medical Devices Class I - Dangerous
The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism.