Smiths Medical ASD, Inc. recalls
Every recall we track for Smiths Medical ASD, Inc. — 221 in all, from 2017–2025 — plus the complaints and injury reports the public filed about them. 6 are rated “stop using now”.
Recalls per year, by danger level
Recalls from Smiths Medical ASD, Inc. fell by more than half in 2025 (20, down from 83 in 2024). 3% rated “stop using now”.
All FDA recall records for Smiths Medical ASD, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 6 | 8 | 1 | 15 |
| 2018 | 2 | 0 | 13 | 0 | 15 |
| 2019 | 0 | 0 | 5 | 0 | 5 |
| 2020 | 0 | 7 | 17 | 1 | 25 |
| 2021 | 0 | 14 | 9 | 0 | 23 |
| 2022 | 0 | 6 | 2 | 0 | 8 |
| 2023 | 0 | 10 | 17 | 0 | 27 |
| 2024 | 1 | 54 | 27 | 1 | 83 |
| 2025 | 3 | 16 | 1 | 0 | 20 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
Most common reasons for Smiths Medical ASD, Inc. recalls
What to do if you have a recalled Smiths Medical ASD, Inc. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Smiths Medical ASD, Inc. recalls
60 shown- Use cautionMedical device
Smiths Medical ASD, Inc. recalls CADD Solis HSPCA Pump ***Updated 5/27/26*** Scope updated to apply specifically to customers using the wireless system.
Smiths Medical recalls CADD Solis HSPCA Pumps with wireless systems that may interrupt therapy, risking serious injury or death. Affected models include specific software versions and pump kits.
Smiths MedicalApr 10, 2025 - Lower riskMedical device
Smiths Medical ASD, Inc. recalls CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL MODE, 1/EA,
Smiths Medical recalls CADD Solis VIP Ambulatory Infusion Pumps with potential thermal damage. Affected models include 2120 series with specific serial numbers and UDI-DI codes. Contact for details.
Smiths MedicalApr 10, 2025 - Use cautionMedical device
Smiths Medical ASD, Inc. recalls CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-09-KYO CADD SOLIS PIB PUMP FOR
Smiths Medical recalls certain CADD-Solis HPCA Ambulatory Infusion Pumps with model numbers 21-2111-0402-09-KYO and others due to false upstream occlusion alarms that can interrupt therapy, risking serious injury or death.
Smiths MedicalApr 10, 2025 - Stop using nowMedical device
Smiths Medical ASD, Inc. recalls CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100
Smiths Medical recalls CAPNOCHECK BCI Airway Adapter (Model BSR) due to risk of breaking off during use, which could cause airway blockage, loss of ventilation, or death. Affected units have specific product codes and lots.
Smiths MedicalFeb 14, 2025 - Use cautionMedical device
Smiths Medical ASD, Inc. recalls Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030
Smiths Medical recalls Portex Endotracheal Tubes with specific item codes due to potential inadequate ventilation causing hypoxia or cardiopulmonary collapse.
Smiths MedicalFeb 13, 2025 - Use cautionMedical device
Smiths Medical ASD, Inc. recalls smiths medical ProPort Plastic Venous Access System, Implantable Venous Access Systems, 82-24
Smiths Medical recalls ProPort Plastic Venous Access Systems due to potential port housing separation from manufacturing defects. Affected units include specific lot numbers and UDI/DI codes.
Smiths MedicalFeb 13, 2025 - Lower riskMedical device
Smiths Medical ASD, Inc. recalls smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP
Smiths Medical recalls PORTEX Tracheal Tube Exchange Guides (15Ch x 70cm) with specific model numbers and lot codes due to potential fluid ingress during reprocessing, which may cause staining or inadequate disinfection.
Smiths MedicalOct 28, 2024 - Use cautionMedical device
Smiths Medical ASD, Inc. recalls medex Arterial Kit 1/EA, Product Code REF MX7827
Smiths Medical recalls medex Arterial Kit 1/EA with Product Code REF MX7827 due to potential inaccurate pressure monitoring. Affected units may have leaks or defects in the TranStar Disposable Pressure Transducer.
Smiths MedicalSep 24, 2024 - Lower riskMedical device
Smiths Medical ASD Inc. recalls smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000
Smiths Medical recalls ORATOR speaking valves for tracheostomy tubes due to potential uncertainty in sterile packaging seal integrity. Affected units include specific model and lot numbers.
Smiths MedicalJul 18, 2024 - Lower riskMedical device
Smiths Medical ASD Inc. recalls CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a component of the following CADD
Smiths Medical recalls CADD-Solis Li-ion rechargeable battery packs (REF 21-2160-XX) sold in ambulatory infusion systems. Damage may cause short circuits, melting the battery case, and charging failure.
Smiths MedicalJul 16, 2024 - Use cautionMedical device
Smiths Medical ASD, Inc. recalls smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model Number REF 21-0270-25, for use with the
Smiths Medical recalls CADD-Solis Li-ion battery AC adapters (model REF 21-0270-25) due to potential plug damage causing exposed contacts or prong separation. All units are affected.
Smiths MedicalJun 26, 2024 - Lower riskMedical device
Smiths Medical ASD Inc. recalls CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24JP
Smiths Medical recalls certain 100mL CADD Medication Cassette Reservoirs (Product Code 21-7302-24JP) due to a weakened weld joint that may cause medication leakage. Affected units have specific lot numbers.
Smiths MedicalJun 26, 2024 - Use cautionMedical device
Smiths Medical ASD Inc. recalls smiths medical portex BLUselect, tracheostomy tube, labeled as follows: 1) BLUSELECT 6.0, CUFFED, NON-FEN, 10/BX, Item
Smiths Medical recalls specific BLUselect tracheostomy tubes (6.0-10.0 sizes) due to potential pilot balloon disconnection. Affected items have unique item numbers and lot numbers listed in the recall. Stop using immediately if you own one of these models.
Smiths MedicalJun 7, 2024 - Lower riskMedical device
Smiths Medical ASD Inc. recalls paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
Smiths Medical ASD, Inc. is a leading manufacturer of medical devices and equipment. We provide innovative solutions for healthcare professionals worldwide.
Smiths Medical ASD, Inc.May 31, 2024 - Lower riskMedical device
Smiths Medical ASD Inc. recalls Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXX
Smiths Medical recalls Pneupac paraPAC Plus 310 ventilator kits with PEEP and CPAP. The tidal volume knob may shift accidentally when set at high or low volumes, potentially causing incorrect ventilation settings.
Smiths MedicalMay 31, 2024 - Use cautionMedical device
Smiths Medical ASD Inc. recalls PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Product
Smiths Medical recalls specific lots of Bivona Tracheostomy Silicone Tubes due to a manufacturing defect that may cause the securement flange to tear. Affected products include various sizes (2.5mm to 5.5mm) with listed lot numbers.
Smiths MedicalMay 29, 2024 - Lower riskMedical device
Smiths Medical ASD Inc. recalls CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 ( 21-2120 , 21-2125 , and 21-2127 ) Indicated for the following
Smiths Medical ASD, Inc. is a leading manufacturer of medical devices and equipment. They specialize in providing high-quality products for healthcare settings.
Smiths Medical ASD, Inc.Feb 27, 2024 - Use cautionMedical device
Smiths Medical ASD Inc. recalls smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
Smiths Medical ASD, Inc. is recalling Model 1705146-1712111 and 1801046-1806116 due to a potential failure in the device's ability to deliver medication accurately.
Smiths Medical ASD, Inc.Feb 7, 2024 - Lower riskMedical device
Smiths Medical ASD Inc. recalls smiths medical Medfusion Model 4000 syringe pump
Smiths Medical recalls Medfusion Model 4000 syringe pumps with specific software versions due to potential delivery errors and alarm issues. Affected units may require software updates to prevent incorrect medication administration.
Smiths MedicalDec 19, 2023 - Lower riskMedical device
Smiths Medical ASD Inc. recalls Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d)
Smiths Medical ASD, Inc. - 4000-0105-78
Smiths Medical ASD, Inc.Dec 19, 2023 - Lower riskMedical device
Smiths Medical ASD Inc. recalls smiths medical Medfusion Model 3500 Syringe pump
Smiths Medical recalls Medfusion Model 3500 syringe pumps with software versions v3.x, v4.x, or v5.0.0 due to potential incorrect dosing and infusion errors. Ensure software v6.0.0 or later is installed.
Smiths MedicalDec 19, 2023 - Use cautionMedical device
Smiths Medical Asd Inc recalls 48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R
Smiths Medical recalls 48-inch inject line rotating adapters with potential medication leaks due to O-ring seal defects. Affected units have specific lot numbers; stop using if you have the product.
Smiths MedicalNov 10, 2023 - Lower riskMedical device
Smiths Medical ASD Inc. recalls Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1
Smiths Medical recalls 31,900 Portex Pro-Vent Arterial Blood Sampling Kits with missing caps that may cause delayed or incorrect test results and blood exposure risks.
Smiths MedicalSep 6, 2023 - Lower riskMedical device
Smiths Medical ASD Inc. recalls Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.
Smiths Medical recalls pediatric tracheostomy tubes with incorrect expiration date labeling on the box. The box shows 3/17/2021 but the tube itself expires 3/17/2026. This may cause confusion in medical use.
Smiths MedicalAug 22, 2023 - Use cautionMedical device
Smiths Medical ASD Inc. recalls Medfusion Syringe Pump, Model 3500-500, v3, v4, v5, and v6
Smiths Medical recalls Medfusion Syringe Pump models 3500-500 v3-v6 due to potential force sensor calibration drift causing false alarms or delayed occlusion detection. Affected units sold before April 2022 may require attention.
Smiths MedicalAug 16, 2023 - Lower riskMedical device
Smiths Medical ASD Inc. recalls PORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filter
Smiths Medical recalls PORTEX 0.5u Hydrophobic Disc Filters with incorrect expiration dates on labels. This labeling error may lead to improper use of the filter.
Smiths MedicalJul 18, 2023 - Lower riskMedical device
Smiths Medical ASD Inc. recalls DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code 66-1991); Swivel Elbow with Suction Port
Smiths Medical recalls DuraLife Autoclavable Double Swivel Elbows with suction ports due to insufficient cleaning and sterilization instructions, risking improper reuse on patients.
Smiths MedicalApr 5, 2023 - Use cautionMedical device
Smiths Medical ASD Inc. recalls CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24 3) REF 21-7302-24, 4) REF 21-7321-24, 5)
Smiths Medical recalls CADD Administration Sets with specific list numbers and lot ranges due to potential underdelivery and false 'No Disposable Attached' alarms. Affected users should check their product details.
Smiths MedicalDec 9, 2022 - Lower riskMedical device
Smiths Medical ASD Inc. recalls Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart
Smiths Medical recalls Medfusion Model 4000 Syringe Infusion Pumps with software versions V1.6.0 or V1.6.1 that may delay sending infusion start messages to electronic health records, potentially affecting patient documentation and treatment programming.
Smiths MedicalOct 10, 2022 - Use cautionMedical device
Smiths Medical ASD Inc. recalls Medfusion Syringe Pump Models: 3500, 3500-0600-00, 3500-0600-01, 3500-0600-249, 3500-0600-50, 3500-0600-51,
Smiths Medical recalls Medfusion Syringe Pump Models 3500 series (including specific software versions) due to potential interruptions in therapy or over-infusion risks. Affected units may display multiple alarm issues that could lead to incorrect dosing or system failures.
Smiths MedicalApr 18, 2022 - Use cautionMedical device
Smiths Medical ASD Inc. recalls Bivona Aire-Cuf Endotracheal Tube
Smiths Medical recalls Bivona Aire-Cuf Endotracheal Tubes with 325mm shaft length due to inadequate pouch seal risking compromised sterile barrier. Check SKUs and lots for affected items.
Smiths MedicalAug 9, 2021 - Lower riskMedical device
Smiths Medical ASD Inc. recalls NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700
Smiths Medical recalls NORMOFLO Irrigation Warming sets (models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700) due to potential aluminum leaching with blood products and longer use. Consumers should check their product codes.
Smiths MedicalAug 6, 2021 - Lower riskMedical device
Smiths Medical ASD Inc. recalls smiths medical portex Tracheal Intubation Stylet, REF 100/120/200, 4.0mm OD X 335mm, 10/box, sterile.
Smiths Medical recalls sterile tracheal intubation stylets with incorrect device in package. Consumers should check product details and contact Smiths Medical for guidance.
Smiths MedicalAug 4, 2021 - Lower riskMedical device
Smiths Medical ASD Inc. recalls Pneupac paraPac plus 300 ventilator kit, REF P300NGB
Smiths Medical recalls Pneupac paraPac Plus 300 ventilator kits with duplicate serial numbers. This may cause confusion in identification and potential safety risks.
Smiths MedicalJul 15, 2021 - Lower riskMedical device
Smiths Medical ASD Inc. recalls JELCO HYPODERMIC NEEDLE-PRO FIXED NEEDLE INSULIN SYRINGE: a) 1.0mL 28G X 1/2" (0.33mm x 13mm), REF 4428-1 b) 1.0mL 29G
Smiths Medical recalls specific insulin syringes with skewed graduation markings that may cause inaccurate insulin doses. Affected models include 1.0mL 28G and 29G syringes with certain lot numbers. Consumers should check their syringes for upward skewing of markings.
Smiths MedicalMay 17, 2021 - Lower riskMedical device
Smiths Medical ASD Inc. recalls PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit, REF 100/596/090 - Product Usage: intended for use in a
Smiths Medical recalls a specific tracheostomy kit model due to incorrect labeling that could lead to improper use in medical settings. Affected units may have been mislabeled as 7.0mm when they are 9.0mm.
Smiths MedicalMay 14, 2021 - Lower riskMedical device
Smiths Medical ASD Inc. recalls ACE MDI Spacer with Small Mask - Product Usage: designed to assist with the delivery of aerosolized medications from
Smiths Medical recalls ACE MDI Spacers with Small Masks due to potential incorrect shipping box labels. This may affect product identification but does not pose a safety risk.
Smiths MedicalMar 31, 2021 - Use cautionMedical device
Smiths Medical ASD Inc. recalls Tubing with male luer lock adapter (Component) a. 76 cm, REF 601280 b. 122 cm, REF 607281. component of extravascular
Smiths Medical recalls specific lots of tubing with male luer lock adapters due to potential insufficient welds in high-pressure adaptors, which could lead to device failure during use.
Smiths MedicalMar 31, 2021 - Use cautionMedical device
Smiths Medical ASD Inc. recalls Tube Tracheostomy and Tube Cuff, Bivona¿ Cuffless Neonatal/Pediatric FlexTend" Tracheostomy Tube (model 60PFS45, lots
Smiths Medical recalls specific model 60PFS45 tracheostomy tubes with incorrect straight neck flange that may cause tissue injury if used improperly.
Smiths MedicalJan 18, 2021 - Lower riskMedical device
Smiths Medical ASD Inc. recalls Portex Acapella DH Vibratory PEP Device - Product Usage: a single patient use device that provides Positive Expiratory
Smiths Medical recalls Portex Acap:ell DH Vibratory PEP devices with wrong model in shipping box. This single-use device for respiratory therapy may not fit patients correctly.
Smiths MedicalDec 21, 2020 - Lower riskMedical device
Smiths Medical ASD Inc. recalls PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, REF 60PFSS45
Smiths Medical recalls specific FlexTend Tracheostomy Tubes due to potential incorrect packaging with a V-neck flange instead of straight flange. Affected units may need verification.
Smiths MedicalDec 15, 2020 - Lower riskMedical device
Smiths Medical ASD Inc. recalls smiths medical portex Loss of Resistance Device, REF 100/398/000
Smiths Medical recalls portex devices with missing sterilization labeling that prohibits reuse. Affected units include specific lot numbers. Contact for remedy details.
Smiths MedicalDec 8, 2020 - Lower riskMedical device
Smiths Medical ASD Inc. recalls Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to provide direct airway access for a
Smiths Medical recalls Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tubes due to incorrect size labeling on the label, which could lead to improper fitting.
Smiths MedicalAug 28, 2020 - Lower riskMedical device
Smiths Medical ASD Inc. recalls CADD Administration Sets, Model #21-7346-24
Smiths Medical recalls CADD Administration Sets (Model #21-7346-24) with potential incorrect air filter assembly. Affected units include specific lot numbers. Consumers should check their product details.
Smiths MedicalJul 14, 2020 - Lower riskMedical device
Smiths Medical ASD Inc. recalls Medfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1
Smiths Medical recalls Medfusion Syringe Pump Model 4000 with specific software versions (V1.5.0-V1.6.1) due to potential inaccurate delivery of medication after interrupted bolus or loading doses. Affected units may require software update or replacement.
Smiths MedicalJun 26, 2020 - Lower riskMedical device
Smiths Medical ASD Inc. recalls PORT-A-CATH¿ II POWER P.A.C. Low Profile" system.
Smiths Medical recalls PORT-A-CATH II Power PAC Low Profile System with 8Fr catheter instead of 6Fr. Affected units may cause complications during procedures.
Smiths MedicalJun 11, 2020 - Use cautionMedical device
Smiths Medical ASD Inc. recalls Pediatric Adjustable Flange Tracheostomy Tube Cuffless
Smiths Medical recalls pediatric tracheostomy tubes with incorrect neck flange size. This may cause breathing issues if used improperly. Affected units include model 60HA30, lot 37941: 3.5mm ID plate instead of 3.0mm.
Smiths MedicalMay 26, 2020 - Use cautionMedical device
Smiths Medical ASD Inc. recalls CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d.
Smiths Medical recalls CADD-Solis VIP ambulatory infusion pumps with specific model and serial numbers due to potential air in line detection failure, which may not alarm if air is present in the tubing.
Smiths MedicalMar 24, 2020 - Lower riskMedical device
Smiths Medical ASD Inc. recalls smiths medical medex CBSS-5ML, Triple set, (172/15cm), Model Number DPSHC0092
Smiths Medical recalls CBSS-5ML Triple Sets (Model DPSHC0092) due to reported pressure shifts and incorrect readings in LogiCal Closed Blood Sampling Systems.
Smiths MedicalMar 10, 2020 - Lower riskMedical device
Smiths Medical ASD Inc. recalls Portex Lumbar Puncture Tray. Anesthesia Conduction Kit. 4826PL-20 - Product Usage: Portex lumbar puncture trays provide
Smiths Medical recalls Portex Lumbar Puncture Tray model 4826PL-20 due to mislabeled inner trays. Affected units may have incorrect SKU numbers.
Smiths MedicalFeb 28, 2020 - Use cautionMedical device
Smiths Medical ASD, Inc. recalls Portex ProVent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes
Smiths Medical recalls Portex ProVent Arterial Blood Sampling Kits with dry lithium heparin for gases and electrolytes due to potential broken luer fittings. Affected units have specific lot numbers.
Smiths MedicalJan 7, 2020 - Lower riskMedical device
Smiths Medical ASD Inc. recalls Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The
Smiths Medical recalls Medfusion 4000 syringe pumps with firmware version 1.7.0 that may lose battery alarms, risking therapy interruption. Affected units have specific serial numbers listed.
Smiths MedicalOct 28, 2019 - Lower riskMedical device
Smiths Medical ASD Inc. recalls GRIPPER Needles sold individually. Labeled as the following item descriptions: 1. NDL, GRIPPER, 22G X 1" (25MM), 12/BX;
Smiths Medical recalls GRIPPER Needles sold individually with certain sizes and lot numbers due to potential for occluded or blocked needles. Affected items include specific models and lot numbers listed in the recall notice.
Smiths MedicalJul 8, 2019 - Lower riskMedical device
Smiths Medical ASD Inc. recalls Smith Medical JELCO Hypodermic Needle-Pro EDGE Safety Device Safety Device Rx Only Sterile Product Usage: Is a
Smith Medical recalls JELCO Hypodermic Needle-Pro EDGE Safety Device due to incorrect needle length and gage. This may cause improper injections or injuries during use.
Smith MedicalFeb 11, 2019 - Lower riskMedical device
Smiths Medical ASD Inc. recalls Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula comes inside a package which is labeled in part,
Smiths Medical recalls Portex Blue Line Ultra Trache: Incorrect size inner cannula may cause improper airway maintenance for tracheostomized patients.
Smiths MedicalFeb 11, 2019 - Lower riskMedical device
Smiths Medical ASD Inc. recalls ProtectIV¿ Plus Safety IV Catheter, sterile. Packaged in a pouch and than into an inner carton.
Smiths Medical recalls Model 306701 ProtectIV Plus Safety IV Catheter due to potential safety mechanism damage. Affected lots include 3635765-3651082. Consumers should check their catheter packaging for lot numbers.
Smiths MedicalNov 26, 2018 - Lower riskMedical device
Smiths Medical ASD Inc. recalls Medex High Pressure Stopcock used to control the direction of IV fluid flow. This device is intended for single use
Smiths Medical recalls Medex High Pressure Stopcocks with potential leaks. These single-use IV devices may leak if defective. Check model numbers and lot numbers listed to see if your item is affected.
Smiths MedicalNov 19, 2018 - Lower riskMedical device
Smiths Medical ASD Inc. recalls Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names:
Smiths Medical ASD, Inc. - 2009786
Smiths Medical ASD, Inc.Oct 15, 2018 - Stop using nowMedical device
Smiths Medical ASD Inc. recalls Jelco(R) ViaValve(TM) safety intravenous (I.V.) catheters, 18G x 1 1/4", Model Number REF 3265, MOD 10 The Jelco(R)
Smiths Medical recalls Jelco ViaValve 18G x 1 1/4" I.V. catheters (Model REF 3265, MOD 10) with a V-shaped puncture risk due to manufacturing adjustments. Affected lots include 3584467-3578512. Stop using immediately to prevent injury.
Smiths MedicalAug 22, 2018 - Lower riskMedical device
Smiths Medical ASD Inc. recalls Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4080P-2, Sterile,
Smiths Medical recalls Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes due to mislabeling. Check labels for incorrect firm name or lot numbers 3306404, 3314069, 3318698.
Smiths MedicalJul 13, 2018
Smiths Medical ASD, Inc. recall questions
How many recalls has Smiths Medical ASD, Inc. had?
221 recalls from Smiths Medical ASD, Inc. are on record with U.S. safety agencies, from 2017–2025.
What is the most recent Smiths Medical ASD, Inc. recall?
Smiths Medical ASD, Inc. recalls CADD Solis HSPCA Pump ***Updated 5/27/26*** Scope updated to apply specifically to customers using the wireless system., dated Apr 10, 2025. Every Smiths Medical ASD, Inc. recall is listed on this page, newest first.
Why are Smiths Medical ASD, Inc. products recalled?
The most common reasons on record: Uncertainty in the seal integrity of the sterile packaging. (5); Potential for certain GRIPPER Needles to contain an occluded or blocked needle. (2).
What should I do if I have a recalled Smiths Medical ASD, Inc. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Smiths Medical ASD, Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.