Smiths Medical ASD Inc.
199 recalls on record · Latest: May 14, 2025
FDA Devices Critical May 14, 2025
CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-09-KYO CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PU…
FDA Devices Critical May 14, 2025
CADD-Solis VIP Ambulatory Infusion Pump; Model/Number: 21-2120-0100-02 21-2120-0100-03 21-2120-0100-06 21-2120-0100-232 21-2120-0100-233 21…
FDA Devices Critical May 14, 2025
CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL MODE, 1/EA, Model Number: 21-2127-0105-…
FDA Devices Critical May 14, 2025
CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA, Model Number: 21-2111-0402-51; 2) PUMP KIT, CAD…
FDA Devices Critical May 14, 2025
CADD Solis HSPCA Pump
FDA Devices Critical Mar 26, 2025
smiths medical ProPort Plastic Venous Access System, Implantable Venous Access Systems, 82-24
FDA Devices Critical Mar 26, 2025
smiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm., 6Fr Introducer, REF 21-…
FDA Devices Critical Mar 26, 2025
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introd…
FDA Devices Critical Mar 26, 2025
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4172-…
FDA Devices Critical Mar 26, 2025
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.6Fr Introd…
FDA Devices Critical Mar 26, 2025
smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9 Fr Introducer, REF 21-4151-24
FDA Devices Moderate Mar 26, 2025
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100
FDA Devices Critical Mar 26, 2025
smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24
FDA Devices Critical Mar 26, 2025
smiths medical ProPort Low Profile Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9Fr Introducer, REF 21-4187-24
FDA Devices Moderate Mar 26, 2025
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214
FDA Devices Critical Mar 26, 2025
smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. (5.8 Fr) x 1.0mm I.D., REF 21-4152-24
FDA Devices Critical Mar 19, 2025
Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/…
FDA Devices Moderate Dec 4, 2024
smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP
FDA Devices Moderate Dec 4, 2024
smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76
FDA Devices Moderate Dec 4, 2024
smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP
FDA Devices Moderate Nov 27, 2024
smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model Number REF 21-0270-25, for use with the CADD-Solis infusion pumps
FDA Devices Critical Nov 6, 2024
CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a component of the following CADD Solis Ambulatory Infusion Syst…
FDA Devices Moderate Oct 30, 2024
medex Arterial Kit 1/EA, Product Code REF MX7827
FDA Devices Moderate Oct 30, 2024
smiths medical SurgiVet Advisor Tech Accessories, Product Code REF V2714
FDA Devices Moderate Oct 30, 2024
medex TranStar DPT w/Stopcock & 3cc Flush 10/EA, Product Code REF MX950SCFT
FDA Devices Moderate Oct 30, 2024
CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24JP
FDA Devices Moderate Oct 30, 2024
smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000
FDA Devices Moderate Oct 30, 2024
medex TranStar Stopcock w/Ext. 10/EA, Product Code REF MXG300242
FDA Devices Moderate Oct 30, 2024
smiths medical portex, Nasopharyngeal Airway, Sizes as follows: a) AIRWAY NASOPHARYNGEAL 6.0MM, REF 100/210/060; b) AIRWAY NASOPHARYNGEAL 6.0MM,…
FDA Devices Moderate Oct 30, 2024
ENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28
FDA Devices Moderate Oct 30, 2024
CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
FDA Devices Moderate Oct 30, 2024
medex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1
FDA Devices Moderate Oct 30, 2024
medex TranStar DPT w/Stopcock & 30cc Flush 10/EA, Product Code REF MX950SCNT
FDA Devices Moderate Oct 30, 2024
smiths medical portex, Y' PIECE 15MM, REF 100/276/000
FDA Devices Moderate Oct 30, 2024
smiths medical portex, Thermovent 1200, 15mm/22mm: a) REF 100/582/000; b) REF 100/582/000JP; c) REF 100/582/000JS
FDA Devices Moderate Oct 30, 2024
medex TranStar KIDS KIT 7INCH CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9547
FDA Devices Moderate Oct 30, 2024
ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product Code 68-2230-28
FDA Devices Moderate Oct 30, 2024
medex TranStar KIDS KIT 34IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9545
FDA Devices Moderate Oct 30, 2024
medex TranStar Patient Mount Monitoring Kit 10/EA, Product Code REF MX9501T
FDA Devices Moderate Oct 30, 2024
medex TranStar MONITORING SET W/SAMPLING PORT 10/EA, Product Code REF MXG300260
FDA Devices Moderate Oct 30, 2024
medex TranStar KIDS KIT 10IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9548
FDA Devices Moderate Oct 30, 2024
medex TranStar DPT w/Two Stopcocks 10/EA, Product Code REF MX950X2SC
FDA Devices Moderate Oct 30, 2024
medex TranStar 84in (213cm) Single Monitoring Kit 10/EA, Product Code REF MX9505T
FDA Devices Moderate Oct 30, 2024
medex TranStar 60in (152cm) Single Monitoring Kit 10/EA, Product Code REF MX9504T
FDA Devices Moderate Oct 30, 2024
medex TranStar SINGLE 84IN SET WITH ANTI-SHUNT STOPCOCK 10/EA, Product Code REF MXG300243R1
FDA Devices Moderate Oct 30, 2024
CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
FDA Devices Critical Oct 2, 2024
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
FDA Devices Critical Sep 18, 2024
Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXX
FDA Devices Critical Sep 18, 2024
smiths medical portex BLUselect, tracheostomy tube, labeled as follows: 1) BLUSELECT 6.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/060CZ; 2) BL…
FDA Devices Critical Sep 18, 2024