💊 Drugs Class I - Dangerous
Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.
All Recalls
95,018 total recalls in our database
💊 Drugs Class I - Dangerous
Subpotent Drug
💊 Drugs Class I - Dangerous
Defective container: loose crimp defect, potential loss of container integrity.
Esomeprazole Magnesium Delayed-Release Capsules, USP 40 mg, packaged in Unit Dose Blister Cards of 6 (10 cards of 6 Capsules each per carton), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC 42292-010-16
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.
💊 Drugs Class I - Dangerous
Subpotent Drug
💊 Drugs Class I - Dangerous
Microbial Contamination of Non-Sterile Product: Product is contaminated with Burkholderia gladioli.
💊 Drugs Class I - Dangerous
Subpotent Drug
11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019)
Karl Storz Endoscopy
🏥 Medical Devices Class I - Dangerous
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
🏥 Medical Devices Class I - Dangerous
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test
Woodside Acquisitions
🏥 Medical Devices Class I - Dangerous
Firm distributed tests which have not been cleared or authorized for marketing or distribution in the United States.
VITEK 2 Systems and VITEK 2 with MYLA.
bioMerieux
🏥 Medical Devices Class I - Dangerous
Software issue where results sent to the LIS via HL7 format for antibiotic screen tests and synergy tests do not include the user-corrected or AES-corrected interpretation. This can potentially lead to incorrect final screen/synergy test results at the LIS.
BF-3C160: EVIS EXERA Bronchovideoscope
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization
🏥 Medical Devices Class I - Dangerous
FDA review concluded that the test is insufficiently supported by clinical performance data, and results reported may not have been accurate (false positives or false negatives).
🏥 Medical Devices Class I - Dangerous
DePuy Synthes Radial Head Replacement System Contraindications added to Electronic Instructions for Use (e-IFU): Absolute contraindications include: Infection, sepsis, osteomyelitis.
BF-MP160F: EVIS EXERA Bronchofibervideoscope
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization
Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV06008008P, Sterile EO, Rx Only
Medtronic Vascular
🏥 Medical Devices Class I - Dangerous
Packaging for Balloon Catheters may be damaged resulting in loss of sterility.
CYSTO-URETHRO-FIBERSCOPE REF 11272C1 CYSTOSCOPE, 15FR X 370MM, ADULT REF 11272C2 and Kit Number 11272CK2 CYSTO-URETHRO-FIBERSCOPE REF 11272CU1 and Kit Number 11272CUK1
Karl Storz Endoscopy
🏥 Medical Devices Class I - Dangerous
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
11272VH-TL 11272VHK-TL HD-VIEW Flexible HD Cysto-Urethroscope Z23875US-BC (10-2021) 11272VHU-TL 11272VHUK-TL HD-VIEW Flexible HD Cysto-Urethroscope Z23875US-BC (10-2021)
Karl Storz Endoscopy
🏥 Medical Devices Class I - Dangerous
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
HemosIL ReadiPlasTin, Part No. 0020301400
Instrumentation Laboratory
🏥 Medical Devices Class I - Dangerous
Variable and out of specification QC results with HemosIL ReadiPlasTin. IL will remove all lots from the market and convert customers to an alternative prothrombin time (PT) reagent, specifically HemosIL RecombiPlasTin 2G.
Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit; COVID 19 Test
Woodside Acquisitions
🏥 Medical Devices Class I - Dangerous
Firm distributed tests which have not been cleared or authorized for marketing or distribution in the United States.