💊 Drugs Class I - Dangerous
Failed impurities/degradation specifications
All Recalls
95,018 total recalls in our database
💊 Drugs Class I - Dangerous
Labeling - product contains undeclared ethyl alcohol
💊 Drugs Class I - Dangerous
cGMP deviations
All Over-The-Counter (OTC) drug products sold by Family Dollar retail stores located in Alabama, Arkansas, Louisiana, Mississippi, Missouri and Tennessee.
Dollar Tree Distribution
💊 Drugs Class I - Dangerous
CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center.
💊 Drugs Class I - Dangerous
Labeling - product contains undeclared ethyl alcohol
Dexamethasone Elixir, USP 0.5 mg/5 mL, Net: 8 fl oz (237 mL) bottle, Rx only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053, NDC 60432-466-08.
Morton Grove Pharmaceuticals
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product.
🏥 Medical Devices Class I - Dangerous
There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
KWIK-STIK, Quality control kit for culture media, sold as: KWIK-STIK (single-pack) Enterococcus faecalis derived from ATCC 51299
Microbiologics
🏥 Medical Devices Class I - Dangerous
This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. A specific lot was found susceptible to Gentamicin Synergy during in-house testing.
🏥 Medical Devices Class I - Dangerous
There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
Real-time shelf life testing failed at 24 months
🏥 Medical Devices Class I - Dangerous
Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dilators from these lots and from other lots were subsequently determined to be affected by a manufacturing nonconformance.
Philips Respironics V60 Plus Ventilator Part Number 1138747
Respironics California
🏥 Medical Devices Class I - Dangerous
A limited number of ventilators were assembled with expired adhesive. If the adhesive fails, a bracket may become loose and potentially damage the capacitors, which could cause the ventilator to stop providing ventilation to the patient. This failure may either activate both visual and audible alarms, or it may not sound or display an alarm (a silent shutdown).
Acorn 130 Stairlift, Brooks 130 Stairlift, Acorn 180 Stairlift, and Acorn Outdoor Stairlift
Acorn Stairlifts
🏥 Medical Devices Class I - Dangerous
The design of the seats did not consistently have the adequate strength required to support the customers weight with continued use.
🏥 Medical Devices Class I - Dangerous
The Lactobacillus acidophilus negative control (item 0243 single KWIK-STIK) contained in the 8164 Cepheid Xpert GBS QC Set and 8165 Cepheid Smart GBS QC Set was found to test positive for Group B Streptococcus (GBS) in some cases. This causes a failure when used as a quality control for the Cepheid Xpert GBS and Cepheid Smart GBS systems. The failure of the quality control test causes a disruption for the testing laboratory which may result in repeated testing or the need for alternative test methods. This recall is applicable to the 8164 and 8165 sets only.
🏥 Medical Devices Class I - Dangerous
There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
🏥 Medical Devices Class I - Dangerous
Product was labelled with the incorrect manufacturing and distribution dates.
🏥 Medical Devices Class I - Dangerous
There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
da Vinci Xi and X 12-8 mm Conductive Cannula Reducer, REF: 470381-11
Intuitive Surgical
🏥 Medical Devices Class I - Dangerous
Conductive Cannula Reducer metal tip may get dislodged from the plastic shaft. If unnoticed, additional surgery may be required to remove the metal tip. If the procedure proceeds without the metal tip, there is potential for energy leakage, which could cause tissue damage. If the metal tip remains in the patient, adhesions may form, which may lead to bowel obstruction and chronic abdominal pain.
Philips Respironics V60 Ventilator Part Number 1053617
Respironics California
🏥 Medical Devices Class I - Dangerous
A limited number of ventilators were assembled with expired adhesive. If the adhesive fails, a bracket may become loose and potentially damage the capacitors, which could cause the ventilator to stop providing ventilation to the patient. This failure may either activate both visual and audible alarms, or it may not sound or display an alarm (a silent shutdown).
MEDLINE Micro-Kill Bleach Germicidal Bleach Wipes
MEDLINE INDUSTRIES, LP - Northfield
🏥 Medical Devices Class I - Dangerous
Micro-Kill Bleach Wipes contain out of specification (low) levels of Sodium Hypochlorite.