PlainRecalls

Smiths Medical ASD Inc.

198 recalls on record · Latest: May 14, 2025

Smiths Medical ASD Inc. Recall Insight

Smiths Medical ASD Inc. appears on 198 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.236% of the federal archive — a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated May 14, 2025, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 3 critical, 42 moderate, and 5 lower-severity recalls. Affected-unit counts are disclosed on 50 of 50 entries — unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (50). The date window on this page runs from Jan 10, 2018 to Oct 27, 2021.

Manufacturer-level browsing is useful when monitoring a single firm for patterns — whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current — deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement — always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Oct 27, 2021

smiths medical portex Loss of Resistance Device, REF 100/398/000

FDA Devices Moderate Oct 27, 2021

medfusion Stopcock, 1-way and 4-way, Model Numbers (REF): a. 081-101BE b. 081-101GE c. 081-101GEE d. 081-101NE e. 081-102NE f. 081-102RE g. 08…

FDA Devices Moderate Oct 20, 2021

smiths medical medex CBSS-5ML, Triple set, (172/15cm), Model Number DPSHC0092

FDA Devices Moderate Oct 20, 2021

smiths medical medex CBSS-5ML Zweifach set, Model Number DPSHC0090

FDA Devices Moderate Oct 20, 2021

smiths medical medex CBSS-5ML, Single Set, (172/15cm), Model Number DPSHC0093

FDA Devices Moderate Oct 20, 2021

smiths medical medex CBSS 5 ml, dreifach proximaler Entnahmeport 60 cm, Model number DPSHC0082

FDA Devices Moderate Oct 20, 2021

medex LogiCal 5mL Closed Blood Sampling System, Model Numbers: a) MX961E181P1 b) MX961E211P1 c) MX962E211P1 d) MX96AE181P1 e) MX96AE211P1

FDA Devices Moderate Oct 20, 2021

smiths medical medex CBSS-5ML, Double set, (172+15cm), Model Number DPSHC0094

FDA Devices Moderate Oct 20, 2021

smiths medical medex CBSS 2-fach Druckmesset mit Option, Model Number DPSHC0076

FDA Devices Critical Sep 15, 2021

NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700

FDA Devices Critical Sep 15, 2021

NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129

FDA Devices Moderate Sep 8, 2021

smiths medical portex Tracheal Intubation Stylet, REF 100/120/200, 4.0mm OD X 335mm, 10/box, sterile.

FDA Devices Critical Jun 16, 2021

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 X 1/2" (0.33mm x 13mm), REF …

FDA Devices Moderate May 5, 2021

ACE MDI Spacer with Small Mask - Product Usage: designed to assist with the delivery of aerosolized medications from metered dose inhaler canisters a…

FDA Devices Moderate Apr 28, 2021

Tubing with male luer lock adapter (Component) a. 76 cm, REF 601280 b. 122 cm, REF 607281. component of extravascular blood-pressure Transducer.

FDA Devices Moderate Apr 28, 2021

Left Heart Kit, Model Number M20268. for blood pressure monitoring.

FDA Devices Moderate Apr 28, 2021

Stopcock rotator (Component): a. 1050 STOPCOCK ROTATOR, OFF HANDLE, Model Number MX1431MR b. 1050 STOPCOCK LEFT ROTATOR, OFF HANDLE, Model Number M…

FDA Devices Moderate Apr 28, 2021

LogiCal Monitoring Set, Model Number DPS564898. for blood pressure monitoring and blood sampling.

FDA Devices Moderate Apr 28, 2021

LogiCal Left Heart Kit, Model Number M20553. for blood pressure monitoring.

FDA Devices Moderate Apr 28, 2021

Manifold rotator (Component): a. 250 2 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1232MR b. 250 3 GANG MANIFOLD ROTATOR, OFF HANDLE, Model N…

FDA Devices Moderate Apr 28, 2021

Gang Cath Lab Set, Model Number M20858R1.for the administration of IV fluids. Stopcocks and manifolds are used to control the direction of IV fluid …

FDA Devices Moderate Apr 28, 2021

Medex 10 IN Pressure Injector Line w/Rot (1200psi) NS. REF B1681R, component of extravascular blood-pressure Transducer.

FDA Devices Moderate Apr 28, 2021

HIGH PRESSURE ROTATOR (Component) a. WITH MALE LUER LOCK, Model Number MX496HP b. WITH FEMALE LUER LOCK, Model Number MX497HP. component of ext…

FDA Devices Moderate Apr 28, 2021

HIGH PRESSURE TUBING, 72IN, Model Number MX152114 (Component). Stopcocks and manifolds are used to control the direction of IV fluid flow.

FDA Devices Moderate Jul 15, 2020

PORT-A-CATH¿ II POWER P.A.C. Low Profile" system.

FDA Devices Moderate Jul 8, 2020

Pediatric Adjustable Flange Tracheostomy Tube Cuffless

FDA Devices Moderate Apr 22, 2020

Portex ProVent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes

FDA Devices Moderate Apr 22, 2020

Portex LineDraw Arterial Blood Sampling Syringe with Dry Lithium Heparin for Gases and Electrolytes

FDA Devices Moderate Oct 30, 2019

GRIPPER Needles sold individually. Labeled as the following item descriptions: 1. NDL, GRIPPER, 22G X 1" (25MM), 12/BX; 2. NDL, GRIPPER, 2…

FDA Devices Moderate Oct 30, 2019

GRIPPER Needles sold as part of PORT-A-CATH II SINGLE LUMEN SYSTEM. Labeled as the following item descriptions: 1. TRAY, PAC, VEN, TI, PU, 1.9M…

FDA Devices Moderate Oct 2, 2019

Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; …

FDA Devices Moderate Jun 12, 2019

Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula comes inside a package which is labeled in part, Product Usage: The Portex …

FDA Devices Moderate Jun 12, 2019

Smith Medical JELCO Hypodermic Needle-Pro EDGE Safety Device Safety Device Rx Only Sterile Product Usage: Is a disposable, single use device inte…

FDA Devices Moderate Feb 27, 2019

Aplicare Povidone Iodine Prep Pads packaged within Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, m…

FDA Devices Moderate Feb 27, 2019

Aplicare Povidone Iodine Prep Pads packaged within Portex Pulsator Arterial Blood Sampling Kit with Liquid Sodium Heparin, models 4037NP-1, 4039-1, 4…

FDA Devices Low Oct 10, 2018

smiths medical portex First Breath Adult Nasal Cannula, REF 001289, Curved Flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage…

FDA Devices Low Oct 10, 2018

smiths medical portex First Breath Adult Nasal Cannula, REF 001283, Non-flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: …

FDA Devices Low Oct 10, 2018

smiths medical portex First Breath Nasal Oxygen Cannula, REF 001293, with Gas Monitoring Line, 305 cm (10ft.) & Female Luer Connector, 213 cm (7ft.) …

FDA Devices Low Oct 10, 2018

smiths medical portex First Breath Adult Nasal Cannula, REF 001285, Flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: For …

FDA Devices Low Sep 26, 2018

Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4080P-2, Sterile, RX. The firm name on the labe…

FDA Devices Moderate Aug 15, 2018

Medfusion Syringe Infusion Pump, containing the Barrel Clamp Guide mechanism

FDA Devices Moderate Jul 18, 2018

BCI Advisor Vital Signs Monitor, Model 9200, Reorder numbers 920654235, 920654235, 920654335A, and 920674235A. (The differences in the reorder numbe…

FDA Devices Moderate Jun 13, 2018

Bivona¿ Tracheostomy Tube Tracheostomy Tubes

FDA Devices Moderate Mar 28, 2018

Medfusion Syringe Pump 3010 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiri…

FDA Devices Moderate Mar 28, 2018

Medfusion Syringe Pump 3500 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiri…

FDA Devices Moderate Mar 28, 2018

Medfusion Syringe Pump 4000 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiri…

FDA Devices Moderate Mar 21, 2018

PORT-A-CATH II PS/Titan, Tray PAC II. Labeled as: a. VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO (1/EA); b. DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO …

FDA Devices Moderate Feb 7, 2018

Graseby 3300 Pump and Graseby 3000 Series Pump Accessories Patient controlled syringe pump. Use for Infusion

FDA Devices Moderate Jan 10, 2018

CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 10008552-001, Smiths Medical ASD, Inc. Rx ONLY

FDA Devices Moderate Jan 10, 2018

Medfusion, Syringe Infusion Pump, Software Version V1.1, Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashfor…

Nearby Manufacturers

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Data Sources

  • Source: FDA + CPSC + NHTSA + USDA FSIS — federal recall filings naming this firm. Verify with FDA, CPSC, NHTSA, or USDA FSIS directly.
  • Source: PlainRecalls Manufacturer Index — firm-level aggregation across all four federal recall feeds