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All Recalls

Every Smiths Medical Asd Inc. Recall

Sorted by most recent. Click any recall for full details.

182 recalls
CriticalFDA
Smiths Medical Asd, Inc.
CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-09-KYO CADD SOLIS PIB PUMP FOR CLINICAL EVALUA...
Medical Devices·185,975 affected·Apr 10, 2025
CriticalFDA
Smiths Medical Asd, Inc.
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-...
Medical Devices·185,975 affected·Apr 10, 2025
CriticalFDA
Smiths Medical Asd, Inc.
CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL MODE, 1/EA, Model Number: 2...
Medical Devices·313,676 affected·Apr 10, 2025
CriticalFDA
Smiths Medical Asd, Inc.
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) P...
Medical Devices·313,676 affected·Apr 10, 2025
CriticalFDA
Smiths Medical Asd, Inc.
CADD Solis HSPCA Pump
Medical Devices·83,833 affected·Apr 10, 2025
CriticalFDA
Smiths Medical Asd, Inc.
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100
Medical Devices·175,994 affected·Feb 14, 2025
CriticalFDA
Smiths Medical Asd, Inc.
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214
Medical Devices·175,994 affected·Feb 14, 2025
CriticalFDA
Smiths Medical Asd, Inc.
smiths medical ProPort Plastic Venous Access System, Implantable Venous Access Systems, 82-24
Medical Implants·0 affected·Feb 13, 2025
CriticalFDA
Smiths Medical Asd, Inc.
smiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm., 6Fr Introdu...
Surgical Devices·8,515 affected·Feb 13, 2025
CriticalFDA
Smiths Medical Asd, Inc.
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., ...
Surgical Devices·12 affected·Feb 13, 2025
CriticalFDA
Smiths Medical Asd, Inc.
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., ...
Surgical Devices·1 affected·Feb 13, 2025
CriticalFDA
Smiths Medical Asd, Inc.
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., ...
Surgical Devices·1,695 affected·Feb 13, 2025
CriticalFDA
Smiths Medical Asd, Inc.
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/...
Medical Devices·0 affected·Feb 13, 2025
CriticalFDA
Smiths Medical Asd, Inc.
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
Surgical Devices·643 affected·Feb 13, 2025
CriticalFDA
Smiths Medical Asd, Inc.
smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24
Surgical Devices·3 affected·Feb 13, 2025
CriticalFDA
Smiths Medical Asd, Inc.
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 ...
Surgical Devices·2,236 affected·Feb 13, 2025
CriticalFDA
Smiths Medical Asd, Inc.
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
Surgical Devices·2,311 affected·Feb 13, 2025
High RiskFDA
Smiths Medical Asd, Inc.
smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP
Medical Devices·10,223 affected·Oct 28, 2024
High RiskFDA
Smiths Medical Asd, Inc.
smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76
Medical Devices·12,282 affected·Oct 28, 2024
High RiskFDA
Smiths Medical Asd, Inc.
smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP
Medical Devices·142,327 affected·Oct 28, 2024
High RiskFDA
Smiths Medical Asd, Inc.
medex Arterial Kit 1/EA, Product Code REF MX7827
Medical Devices·2,232 affected·Sep 24, 2024
High RiskFDA
Smiths Medical Asd, Inc.
smiths medical SurgiVet Advisor Tech Accessories, Product Code REF V2714
Medical Devices·0 affected·Sep 24, 2024
High RiskFDA
Smiths Medical Asd, Inc.
medex TranStar DPT w/Stopcock & 3cc Flush 10/EA, Product Code REF MX950SCFT
Medical Devices·10 affected·Sep 24, 2024
High RiskFDA
Smiths Medical Asd, Inc.
medex TranStar Stopcock w/Ext. 10/EA, Product Code REF MXG300242
Medical Devices·380 affected·Sep 24, 2024
High RiskFDA
Smiths Medical Asd, Inc.
medex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1
Medical Devices·400 affected·Sep 24, 2024
High RiskFDA
Smiths Medical Asd, Inc.
medex TranStar DPT w/Stopcock & 30cc Flush 10/EA, Product Code REF MX950SCNT
Medical Devices·1,000 affected·Sep 24, 2024
High RiskFDA
Smiths Medical Asd, Inc.
medex TranStar KIDS KIT 7INCH CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9547
Medical Devices·3,280 affected·Sep 24, 2024
High RiskFDA
Smiths Medical Asd, Inc.
medex TranStar KIDS KIT 34IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9545
Medical Devices·250 affected·Sep 24, 2024
High RiskFDA
Smiths Medical Asd, Inc.
medex TranStar Patient Mount Monitoring Kit 10/EA, Product Code REF MX9501T
Medical Devices·1,740 affected·Sep 24, 2024
High RiskFDA
Smiths Medical Asd, Inc.
medex TranStar MONITORING SET W/SAMPLING PORT 10/EA, Product Code REF MXG300260
Medical Devices·1,640 affected·Sep 24, 2024
High RiskFDA
Smiths Medical Asd, Inc.
medex TranStar KIDS KIT 10IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9548
Medical Devices·3,490 affected·Sep 24, 2024
High RiskFDA
Smiths Medical Asd, Inc.
medex TranStar DPT w/Two Stopcocks 10/EA, Product Code REF MX950X2SC
Medical Devices·1,110 affected·Sep 24, 2024
High RiskFDA
Smiths Medical Asd Inc.
smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000
Medical Devices·27,971 affected·Jul 18, 2024
High RiskFDA
Smiths Medical Asd Inc.
smiths medical portex, Nasopharyngeal Airway, Sizes as follows: a) AIRWAY NASOPHARYNGEAL 6.0MM, REF 100/210/060; b) AIRWAY NASOPHARY...
Medical Devices·251,591 affected·Jul 18, 2024
High RiskFDA
Smiths Medical Asd Inc.
smiths medical portex, Y' PIECE 15MM, REF 100/276/000
Medical Devices·9,133 affected·Jul 18, 2024
High RiskFDA
Smiths Medical Asd Inc.
smiths medical portex, Thermovent 1200, 15mm/22mm: a) REF 100/582/000; b) REF 100/582/000JP; c) REF 100/582/000JS
Medical Devices·141,196 affected·Jul 18, 2024
CriticalFDA
Smiths Medical Asd Inc.
CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a component of the following CADD Solis Ambulatory I...
Medical Devices·138,039 affected·Jul 16, 2024
High RiskFDA
Smiths Medical Asd Inc.
CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24JP
Medical Devices·109,563 affected·Jun 26, 2024
High RiskFDA
Smiths Medical Asd Inc.
ENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28
Medical Devices·120,960 affected·Jun 26, 2024
High RiskFDA
Smiths Medical Asd Inc.
CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Medical Devices·125,928 affected·Jun 26, 2024
High RiskFDA
Smiths Medical Asd Inc.
ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product Code 68-2230-28
Medical Devices·2,881,080 affected·Jun 26, 2024
High RiskFDA
Smiths Medical Asd, Inc.
smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model Number REF 21-0270-25, for use with the CADD-Solis infusion...
Medical Devices·156,400 affected·Jun 26, 2024
CriticalFDA
Smiths Medical Asd Inc.
smiths medical portex BLUselect, tracheostomy tube, labeled as follows: 1) BLUSELECT 6.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/0...
Medical Devices·799,732 affected·Jun 7, 2024
CriticalFDA
Smiths Medical Asd Inc.
smiths medical portex BLUperc Percutaneous Diliation Procedural Trays with BLUselect tracheostomy tubes, labeled as follows: 1) BLUper...
Medical Devices·41,691 affected·Jun 7, 2024
CriticalFDA
Smiths Medical Asd Inc.
smiths medical portex BLUgriggs Percutaneous Dilation Procedural Trays with BLUselect tracheotomy tubes, labeled as follows: 1) BLUgri...
Surgical Devices·12,234 affected·Jun 7, 2024
CriticalFDA
Smiths Medical Asd Inc.
Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXX
Respiratory Devices·10,240 affected·May 31, 2024
CriticalFDA
Smiths Medical Asd Inc.
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
Respiratory Devices·11,244 affected·May 31, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Product Code/List Numb...
Medical Devices·0 affected·May 29, 2024