💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility
All Recalls
95,038 total recalls in our database
Glauco-Catar Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
Herbal Doctor Remedies
💊 Drugs Class I - Dangerous
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Stone Purger Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
Herbal Doctor Remedies
💊 Drugs Class I - Dangerous
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
DRIVELINE MANAGEMENT SYSTEM 1 DAILY Kit Code: DT18440A - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient population.
Centurion Medical Products
🏥 Medical Devices Class I - Dangerous
Potential for sterile packaging to be compromised
SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 83014
MicroAire Surgical Instruments
🏥 Medical Devices Class I - Dangerous
There was a higher than normal incidence rate of the blade not retracting when tightening.
Ingenuity Core128 Model # 728323, computed tomography x-ray system
Philips Medical Systems (Cleveland)
🏥 Medical Devices Class I - Dangerous
In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied
IDEAL IMPLANT Structured Breast Implant, saline breast implant, in the following sizes: 210cc, 240cc, 270cc, 300cc, 335cc, 370cc, 405cc, 440cc, 475cc, 515cc, 555cc, 595cc, 635cc, and 675cc.
Ideal Implant Incorporated
🏥 Medical Devices Class I - Dangerous
The implants were deflating due to a piece of silicone disrupting the seal of the posterior valve shortly after implantation.
DAILY DRIVELINE KIT Kit Code: DM940 - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient population.
Centurion Medical Products
🏥 Medical Devices Class I - Dangerous
Potential for sterile packaging to be compromised
CIRCUMCISION TRAY Kit Code: CIT2245 - Product Usage: Kit is used for performing circumcision procedures on newborns.
Centurion Medical Products
🏥 Medical Devices Class I - Dangerous
Potential for sterile packaging to be compromised
VITROS 5600 Integrated System, clinical chemistry analyzer
Ortho Clinical Diagnostics
🏥 Medical Devices Class I - Dangerous
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
Regard ¿ custom surgical pack labeled as "LAPAROSCOPIC - OSU" including recalled Stryker part numbers 0620 040 660 Pneumosure High Flow II Tubeset, 0620 040 690 Pneumosure Heated Tubeset with RTP and 0620 040 680 Pneumosure High Flow Tubeset with RTP.
ROi Consolidated Service Center (CSC)
🏥 Medical Devices Class I - Dangerous
Resource Optimization & Innovation (ROi) has received a recall notice from Stryker regarding tube sets potentially detaching from the cassette, which can lead to leaking gas or a hissing sound.
Human Assayed Multi-Sera Level 2, Model NO. HN1530 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The Human Assayed Multi-sera is for the control of accuracy.
Randox Laboratories, Limited
🏥 Medical Devices Class I - Dangerous
The RX Series control target and range value for ALT (Tris buffer without P5P 37C), Bicarbonate and Gamma-GT has been incorrectly assigned in specific lots of the Human Assayed Multi-Sera Controls.
🏥 Medical Devices Class I - Dangerous
Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact could be the inability to deliver high voltage therapy. There is no available option to verify the vulnerability status for implanted devices.
STERILE GRAVES VAGINAL SPECULUM MEDIUM Kit Code # GVS10MST - Product Usage:The speculum is used to spread the walls of the vagina to facilitate examination. It is used by medical professionals in a clinical setting.
Centurion Medical Products
🏥 Medical Devices Class I - Dangerous
Potential for sterile packaging to be compromised
Brilliance 64 Model # 728231, computed tomography x-ray system
Philips Medical Systems (Cleveland)
🏥 Medical Devices Class I - Dangerous
In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied
🏥 Medical Devices Class I - Dangerous
During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop.
🏥 Medical Devices Class I - Dangerous
Reports when using Rheumatoid Factor test kits, control and negative samples may be elevated following a sample containing high levels of IgG . The negative control may report out of range; a negative sample may recover as a low positive which could contribute to an incorrect or premature diagnosis of rheumatoid.
🏥 Medical Devices Class I - Dangerous
A voluntary recall of a lot (67924) of Independent Care System due to the potential for damaged Sodium Bicarbonate Mouthpaste (cosmetic) tubes.
🏥 Medical Devices Class I - Dangerous
When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen.
Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.