FDA Device Recalls

Class IOngoing

Medline Fluid Delivery Set with Drip Chamber: 1) MTO,135,YELLOW,MICRO,SPK-MAIMONIDES, Item Number: 60130527; 2) MTO,ANGIO,DOUBLE,SPIKE,KIT,KENNEDY HLTH, Item Number: 65111341; 3) MTO,ANGIO,SINGLE,SPIKE,KIT, Item Number: 65232486; 4) MTO,ANGIO,SINGLE,SPIKE,KIT,GOOD,SAM, Item Number: 65071193; 5) MTO,NEURO,FLUSH,SPIKE,KIT,BLUE,FLORIDA, Item Number: 600604422; 6) MTO,NEURO,KIT,-,JERSEY,SHORE PG, Item Number: 60100045; 7) MTO,RADIOLOGY,KIT,HAMOT MED CEN, Item Number: 650801715; 8) MTS,135,CDS,IV,TUBE-JEFFERSON UNIV., Item Number: 60232481; 9) MTS,135,YELLOW,MICRO,SPIKE,LUTHERAN MED, Item Number: 60120583; 10) MTS,ANGIO,NEURO,KIT,NORTH SHORE UNIV, Item Number: 601403920; 11) MTS,CUST. FILTER-NEWYORK UNIVERSITY, Item Number: 62140602; 12) MTS,INTERV,NEURO,KIT-WESTCHESTER,MC, Item Number: 602301614; 13) MTS,NEU,NORTH SHORE HOSPITAL, Item Number: 6010771601; 14) MTS,NEURO,KIT, Item Number: 600602914; 15) MTS,NEURO,KIT,2,NEWENGLAND MED CTR, Item Number: 601400111; 16) MTS,NEURO,KIT,YLW&RED,FLORIDA HOSP, Item Number: 600604423; 17) MTS,NEURO,KIT-JOHN,F,KENNEDY MED CENTER, Item Number: 60110552; 18) MTS,NEURO,KIT-OVERLOOK HOSPITAL PG, Item Number: 60150035; 19) MTS,NEURO,SPIKE,KIT,CAPITAL HLTHSYS-FULD, Item Number: 60182723; 20) MTS,NEURO-RADIOLOGY,KIT-YALE-NEWHAVEN, Item Number: 602500214; 21) MTS,STROKE/EMBO,KIT,NORTH SHORE UNIV, Item Number: 601403921; 22) MTS,YELLOW,/,RED,MULTILINE,KIT,MAIMONIDE, Item Number: 601305210; 23) MTS,YELLOW,/,RED,MULTILINE,KIT,MAIMONIDE, Item Number: 601400110;

MEDLINE INDUSTRIES, LP - Northfield

Fluid Delivery Sets were incorrectly assembled with a white macro drip chamber instead of the required grey micro drip chamber. The macro drip chamber delivers three times more fluid per drop than the micro drip chamber.

December 16, 2024 · DeviceView details →

Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002AP

Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002A

Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is designed to be attached to the instrument channel port of Olympus endoscopes to allow both irrigation and the use of endo-therapy accessories.

Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices.

PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

Impella RP Flex with SmartAssist; Product Number: 1000323;

VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)

ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model Number L331)

ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI (Model Number L131)

VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228)

Impella RP with SmartAssist; Product Number: 0046-0035;

ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722)

Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 1050832, 1050839, 1050840, 1050841, 1050842

JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L

VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. Indicated for use in minimally invasive surgery allowing access for vessel harvesting.

Vasoview Hemopro 2 (w/Vasoshield) Endoscopic Vessel Harvesting System. Model Numbers: VH-4001. Indicated for use in minimally invasive surgery allowing access for vessel harvesting.

Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004

Sheath, 18 Fr., 130 mm (REF: WA2PS18S), gastroenterology-urology endoscopic access overtube.