CGMP Deviations
All Recalls
95,064 total recalls in our database
Metoprolol Succinate Extended-Release Tablets, Rx Only, 100 mg, 100 tablets bottles (NDC: 45963-677-11) and 1,000 tablets bottles (NDC: 45963-677-96), Teva Pharmaceuticals, Parsippany, NJ 07054.
Teva Pharmaceuticals USA
💊 Drugs Class I - Dangerous
Failed Dissolution Specifications
💊 Drugs Class I - Dangerous
CGMP Deviations
SILINTAN 25/pills, packaged in a 25-count bottle, Shanghai Chinese Medical Works, Shanghai, China
ANTHONY TRINH, 123Herbals
💊 Drugs Class I - Dangerous
Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam.
Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent reflux of body fluids.
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
Potential for rubber fragment detachment during use.
🏥 Medical Devices Class I - Dangerous
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent leakage of body fluids.
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
Potential for rubber fragment detachment during use.
🏥 Medical Devices Class I - Dangerous
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
🏥 Medical Devices Class I - Dangerous
Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.
🏥 Medical Devices Class I - Dangerous
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
🏥 Medical Devices Class I - Dangerous
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
Staar Surgical AG
🏥 Medical Devices Class I - Dangerous
Toric Implantable Collamer for correction/reduction of myopia in phakic eyes with astigmatism were labeled as 12.1 mm length but are 12.6 mm length lenses, so there is the potential for excessive vault, which may cause: Significant reduction of irido-corneal angles, Significant shallowing of anterior chamber, Patient discomfort, Elevated IOP/Angle closure, Unreactive pupil, Lens exchange/removal.
🏥 Medical Devices Class I - Dangerous
There is the potential for the length of the trocar shaft to be too long.
🏥 Medical Devices Class I - Dangerous
A potential weakness has been identified in the probe body, so that, in a specific production batch, liquid may leak from the terminal part of the casing near the cable.
Software defect, which allows the system to accept erroneous, non-monotonous calibrations for Spline-type assays. Cobas pro integrated solutions is an automated analyzer, intended for running qualitative, semi-quantitative and quantitative clinical chemistry and immunochemistry assays, as well as ion-selective measurements. When an erroneous calibration is active, the instrument fails to calculate new values and instead repeats the last successfully calculated result from any Spline-type assay for all subsequent measurements, leading to identical and erroneous patient and QC results. The defect could lead to patients receiving erroneous lab results, which could result in a remote risk of serious adverse health consequences. The following assays use spline type calibration and are affected by this issue: Cystatin C Gen.2, Ferritin Gen.4, Lipoprotein (a) Gen. 2, Lipoprotein (a) molarity, Vancomycin Gen.3, Kappa Free Light Chains Partner Channel, Lambda Free Light Chains Partner Channel, and fCAL turbo Partner Channel.
🏥 Medical Devices Class I - Dangerous
Under certain workflows, patient information shown in the viewer may not match the images displayed on Centricity Universal Viewer Zero Footprint Client (ZFP) with versions ZFP v6.0: SP11.6, SP11.6.0.1 and SP11.6.1 on systems with Patient Timeline installed,
🏥 Medical Devices Class I - Dangerous
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
Atellica CH Urine Albumin (UAlb). Material Number: 11537225
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
Falsely depressed UAlb patient results may occur. Affected samples with any urine albumin concentration above the UAlb measuring interval >40.0 mg/dL may report values between 6.2 mg/dL and 40.0 mg/dL.
🏥 Medical Devices Class I - Dangerous
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
🏥 Medical Devices Class I - Dangerous
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.