💊 Drugs Class I - Dangerous
CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
All Recalls
95,114 total recalls in our database
DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fresenius Medical Care NA Waltham, MA 02451, NDC 49230-206-62.
Fresenius Medical Care Holdings
💊 Drugs Class I - Dangerous
Lack of Sterility Assurance
Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufactured for: Azurity Pharmaceuticals, Woburn, MA 01801, NDC 52652-9001-1
Azurity Pharmaceuticals
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months.
The sterility of microcatheter and infusion system devices cannot be guaranteed.
🏥 Medical Devices Class I - Dangerous
The bolus calculator is not recording the decimal point if it is the first value entered when changing a bolus dose. This may lead to an over-delivery of insulin to the user if the user does not recognize the error on the bolus calculator screen or the confirmation screen prior to starting the bolus.
🏥 Medical Devices Class I - Dangerous
ROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was subsequently recalled by the component manufacturer.
Xstar Kojo Safety Slit Knife, 2.5mm 45¿ Bevel Up, Part Number 373025
Beaver Visitec International
🏥 Medical Devices Class I - Dangerous
One lot of Part Number 373025, Xstar¿ Kojo Safety Slit Knife 2.5mm 45¿ bevel up, incorrectly contains a bevel down blade instead of a bevel up blade.
Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.
Medtronic
🏥 Medical Devices Class I - Dangerous
Seal defects could compromise the ability of the product packaging to maintain sterility.
Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / STERILE - LATEX FREE
Busse Hospital Disposables
🏥 Medical Devices Class I - Dangerous
Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. Nurse Assist identified product in distribution for which the required sterility assurance level (SAL) of 10^-6 cannot be guaranteed. Risks to patients if product is used include blood stream infections, urinary tract infections, or respiratory infections; in the worst-case scenario, there is risk of sepsis or death.
Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797
Encore Medical
🏥 Medical Devices Class I - Dangerous
Mislabeling
Merit Pursue Microcatheter, REF: 28HC17130SN, 28HC17150ST/A, 29HC2015045/A, 29HC20150SN/A, 29HC20150ST, CE 2797, STERILEEO, Rx ONLY
Merit Medical Systems
🏥 Medical Devices Class I - Dangerous
The sterility of microcatheter and infusion system devices cannot be guaranteed.
EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only
Natus Medical Incorporated
🏥 Medical Devices Class I - Dangerous
Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.
KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, repositioners, and retainers Item No.: 4220011
Keystone Industries
🏥 Medical Devices Class I - Dangerous
Keyprint Keysplint Hard Clear 1 kg resin bottles were inadvertently packaged with the wrong Instructions for Use. Keysplint Hard Clear were placed inside a zip lock bag along with KeySplint Soft Instructions for Use (IFU).
External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only
Natus Medical Incorporated
🏥 Medical Devices Class I - Dangerous
Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.
🏥 Medical Devices Class I - Dangerous
Mislabeling
Conventional Knife Crescent 2.5mm, 55 degrees bevel up, Part Number 373807
Beaver Visitec International
🏥 Medical Devices Class I - Dangerous
One lot of Conventional Crescent Knife 2.5mm, 55 degrees bevel-up contains a bevel down blade.
Catalog No. 1443 DRESSING CHANGE TRAY / STERILE - LATEX FREE
Busse Hospital Disposables
🏥 Medical Devices Class I - Dangerous
Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. Nurse Assist identified product in distribution for which the required sterility assurance level (SAL) of 10^-6 cannot be guaranteed. Risks to patients if product is used include blood stream infections, urinary tract infections, or respiratory infections; in the worst-case scenario, there is risk of sepsis or death.
🏥 Medical Devices Class I - Dangerous
The following features have been disabled from the web-based portal because the FDA has not evaluated these features for safety and effectiveness: Notifications via email feature; AIC alarm color on case tile feature; Sort case tiles by AIC alarm color feature; Pump metric display on case tile feature
Catalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE
Busse Hospital Disposables
🏥 Medical Devices Class I - Dangerous
Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. Nurse Assist identified product in distribution for which the required sterility assurance level (SAL) of 10^-6 cannot be guaranteed. Risks to patients if product is used include blood stream infections, urinary tract infections, or respiratory infections; in the worst-case scenario, there is risk of sepsis or death.
Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD
Covidien
🏥 Medical Devices Class I - Dangerous
Due to software issue, New systems may exhibit an error which may prohibit use of new systems resulting in system being inoperable