United States Recalls
Consumer recalls from the FDA, CPSC, NHTSA, and USDA FSIS.
LSL Healthcare, Standard Central Line Dressing Change Kit, Model/Catalog Number:...
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
Flamingo Funnel Medium, Model Number SQ20012-02
Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
Medline Kits: 1) GENERAL LAPAROSCOPY, Model Number: CDS930027Y
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog...
Potential for product to contain foreign matter, confirmed to be inspect fragments.
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117...
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18...
The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Sy...
Unapproved design changes to the products outside of the 510(k) clearance.
AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 2 R/O Markers; ACCU...
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical In...
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashvi...
Lack of Assurance of Sterility
Medline Kits: 1) GYN LAPAROSCOPY PACK, Model Number: DYNJ41257F
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Medline Kits: 1) ARTHROGRAM TRAY, Model Number: DYNJ07425; 2) TOL NEURO ANGIO...
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Newmar Corporation - Front Chin Spoiler May Detach During Transit
A detached spoiler may become a road hazard, increasing the risk of a crash.
FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHET...
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 65CM 03...
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Sy...
Unapproved design changes to the products outside of the 510(k) clearance.
SALUTE SEASONINGS; Ground All Spice; Net Wt 16oz; Unistel Industries 650 Blossom...
Product may be contaminated with Salmonella.
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115...
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LSL Healthcare, IV Start Kit, Model/Catalog Number: 3131
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
LSL Healthcare, Foley Urine Collection Kit, Model/Catalog Number: 1555
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994
The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433
The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).
Flamingo Funnel Large, Model Number SQ20012-03
Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code: (01)108019022203...
Due to receiving a notice from a supplier that the liquid adhesive were incorrectly manufactured