PlainRecalls

Smiths Medical Asd, Inc.

Compiled from official public sources by the editorial team.

293 recalls on record · Latest: May 14, 2025

Smiths Medical Asd, Inc. Recall Insight

Smiths Medical Asd, Inc. appears on 293 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.288% 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 13 critical, 36 moderate, and 1 lower-severity recalls. Affected-unit counts are disclosed on 49 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 Oct 20, 2021 to Aug 14, 2024.

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 Critical Aug 14, 2024

CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close pro…

FDA Devices Moderate Apr 24, 2024

Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4…

FDA Devices Moderate Apr 24, 2024

Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716

FDA Devices Moderate Apr 24, 2024

Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) …

FDA Devices Moderate Apr 24, 2024

Smiths Medical Model 3010 Syringe pumps: a. Protege Model 3010, b. Medfusion Model 3010A, c. Protege UK Model 3010E

FDA Devices Critical Mar 27, 2024

smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS

FDA Devices Critical Mar 27, 2024

smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

FDA Devices Critical Feb 7, 2024

smiths medical Medfusion Model 3500 Syringe pump

FDA Devices Critical Feb 7, 2024

smiths medical Medfusion Model 4000 syringe pump

FDA Devices Moderate Jan 24, 2024

48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R

FDA Devices Moderate Jan 24, 2024

Medex 20IN (50.8CM) INJ LINE ROTATING ADAPT, List Number MX682R

FDA Devices Moderate Jan 24, 2024

1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL

FDA Devices Moderate Jan 24, 2024

HIGH PRESSURE ROTATOR WITH MALE LUER LOCK, List Number MX496HP

FDA Devices Moderate Jan 24, 2024

HIGH PRESSURE ROTATOR WITH FEMALE LUER LOCK, List Number MX497HP

FDA Devices Moderate Jan 24, 2024

6IN PRESSURE TUBING, List Number MX20617

FDA Devices Moderate Jan 24, 2024

Medex LOGICAL CATH LAB KIT, List Number M20754

FDA Devices Moderate Jan 24, 2024

20IN (50.8CM) BRAIDED INJ LINE, ROTATING ADAPT, List Number MX682BR

FDA Devices Moderate Jan 24, 2024

Medex 700PSI STOPCOCK W/ROTATOR, List Number MX4331R

FDA Devices Moderate Nov 8, 2023

Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.

FDA Devices Moderate Nov 1, 2023

Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1

FDA Devices Moderate Oct 18, 2023

Medfusion Syringe Pump, Model 3500-500, v3, v4, v5, and v6

FDA Devices Moderate Oct 18, 2023

Medfusion Syringe Pump, Model 3500-0600-XX: a) 0600-00; b) 0600-01; c) 0600-50; d) 0600-51; e) 0600-82; f) 0600-249; software versions…

FDA Devices Moderate Oct 18, 2023

Medfusion Syringe Pump, Model 4000-XXXX-XX: a) 0100-50, b) 0100-249, c) 0101-50, d) 0101-51, e) 0101-78, f) 0101-249, g) 0105-51, h) 0…

FDA Devices Moderate Oct 18, 2023

Medfusion Syringe Pump, Model 3500VX-500, v3, v4, v5, and v6

FDA Devices Moderate Oct 18, 2023

Medfusion ASSEMBLY PLUNGER CASE LEFT 1/EA, Component Number G6001587, used on infusion pump

FDA Devices Moderate Oct 18, 2023

Medfusion PLUNGER FLOAT PLATE, Component Number G6000069, used on infusion pump

FDA Devices Moderate Sep 6, 2023

PORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filter

FDA Devices Moderate May 24, 2023

DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code 66-1991); Swivel Elbow with Suction Port for use with breathing circuits

FDA Devices Moderate May 24, 2023

DuraLife Autoclavable Silicone Extension Tube, REF 60-1510 (UltraSet Product Code 66-2505); Swivel Elbow with Suction Port for use with breathing cir…

FDA Devices Moderate May 24, 2023

DuraLife Autoclavable Silicone Extension Tube, REF 60-1502 (UltraSet Product Code 66-2509); Non-Ported Double Swivel Elbow for use with breathing cir…

FDA Devices Critical Feb 8, 2023

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) REF 21-7322-24, 6) REF 21-7…

FDA Devices Critical Feb 8, 2023

CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24

FDA Devices Critical Feb 8, 2023

CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24, 3) REF 21-7302-24, 4) REF 21-7308-24, 5) REF 21-7309-24, 6) REF 21…

FDA Devices Critical Feb 8, 2023

CADD Administration Set, List Numbers: a) REF 21-7600-24, b) REF 21-7609-24, c) REF 21-7624-24, d) REF 21-7649-24, e) REF 21-7600-24JP, f) REF …

FDA Devices Critical Feb 8, 2023

CADD Administration Set, List Numbers: a) REF 21-7308-24, b) REF 21-7309-24, c) REF 21-7310-24, d) REF 21-7308-24JP, e) REF 21-7309-24JP. Comp…

FDA Devices Moderate Nov 30, 2022

Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump Programming (SPP) feature in…

FDA Devices Critical Jun 29, 2022

Medfusion Syringe Pump Models: 3500, 3500-0600-00, 3500-0600-01, 3500-0600-249, 3500-0600-50, 3500-0600-51, 3500-0600-82, 3500-306, 3500-402, 3500-4…

FDA Devices Critical Jun 29, 2022

Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-2…

FDA Devices Moderate Feb 23, 2022

Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3010A Syringe Infusion Pumps serviced during the same time period in whic…

FDA Devices Low Nov 3, 2021

Pneupac paraPac plus 300 ventilator kit, REF P300NGB

FDA Devices Moderate Nov 3, 2021

Bivona Aire-Cuf Endotracheal Tube

FDA Devices Moderate Nov 3, 2021

Bivona Uncuffed Wire Endotracheal Tubes,

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 Critical Oct 27, 2021

CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-21…

FDA Devices Moderate Oct 27, 2021

CADD Administration Sets, Model #21-7346-24

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

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

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Data Sources

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

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.