💊 Drugs Class I - Dangerous
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
All Recalls
95,094 total recalls in our database
💊 Drugs Class I - Dangerous
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag, Rx Only, Compounded by: Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, Massachusetts 01801-1042 United States, NDC 71546-451-25
New England Life Care, Inc.
💊 Drugs Class I - Dangerous
Product Mix up; Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride
💊 Drugs Class I - Dangerous
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
💊 Drugs Class I - Dangerous
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
💊 Drugs Class I - Dangerous
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
💊 Drugs Class I - Dangerous
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
💊 Drugs Class I - Dangerous
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
💊 Drugs Class I - Dangerous
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
💊 Drugs Class I - Dangerous
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
💊 Drugs Class I - Dangerous
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
🏥 Medical Devices Class I - Dangerous
Potential Loss of X-ray-When the full disk capacity is reached, X-Ray functionality will cease to be available there will be a sudden interruption of the procedure
Procedure packs: (1) Medline Sterile Arthroscopy Pack, REF: DYNJ64242B; (2) Medline Sterile Shoulder Pack, REF: DYNJ64250A; and (3) Medline Sterile Upper Extremity Pack, REF: DYNJ64253B.
MEDLINE INDUSTRIES, LP - Northfield
🏥 Medical Devices Class I - Dangerous
The kits were damaged by water.
QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 10000-USA 701070412 HMO 11000-USA 701070416
Maquet Medical Systems USA
🏥 Medical Devices Class I - Dangerous
Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.
🏥 Medical Devices Class I - Dangerous
Contains the incorrect implant in the packaging. The packaging incorrectly contains the opposite side of the implant (Lateral-Right/Medial-Left instead of Medial-Right/Lateral-Left).
QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. BEQ-HMO 50000-USA 701067905 HMO 50000-USA 701067891 HMO 51000-USA 701067895
Maquet Medical Systems USA
🏥 Medical Devices Class I - Dangerous
Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.
Intelli-C, Left side suspended Tabletop, REF: 03400010
NRT X-RAY A/S
🏥 Medical Devices Class I - Dangerous
There is a potential that the drive shaft in the detector up/down (IDE) movement of the X-Ray machine may break which causes the detector to move until it is stopped by the movement end-stop.
QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HMO 31000-USA 701070388
Maquet Medical Systems USA
🏥 Medical Devices Class I - Dangerous
1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.
🏥 Medical Devices Class I - Dangerous
Device failed to function as intended and/or failed to conform to their design specifications.
🏥 Medical Devices Class I - Dangerous
A component within a limited number of Elekta Linacs has been realized to be non-compliant to IEC 60601