PlainRecalls

Smiths Medical Asd, Inc.

Compiled from official public sources by the publisher.

293 recalls on record · Latest: May 14, 2025

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Agency notice ledger

Federal filing book Smiths Medical Asd, Inc. HEAVY-BOOK · SINGLE-AGENCY

#37 of 14,151 · 293 notices · 0.281% archive

  • BOOK 293 notices
  • RANK #37 of 14,151
  • SHARE 0.281% archive
  • AGENCY FDA Devices (293)
  • CAT medical devices
  • CATS 1 category
  • LATEST May 14, 2025
  • PHOTO Blue Bell Creameries,…

Nearest notice-volume peer: Blue Bell Creameries, L.P. (1 notice gap)

Smiths Medical Asd, Inc. accounts for about 0.281% of the 104,423-notice archive on 293 distinct filings — a heavy share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

Smiths Medical Asd, Inc.'s standing among 14,151 recalling firms

Smiths Medical Asd, Inc. ranks 37th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Smiths Medical Asd, Inc. vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

293 37th of 14151 higher than 14,114 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Smiths Medical Asd, Inc. in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Smiths Medical Asd, Inc. holds about 0.281% of archive notices alongside 293 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
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 proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
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) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
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) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500
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: v3, v4, v5, and v6
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) 0105-78, i) 0105-249, j) 0106-00, k) 0106-01, l) 0106-231, m) 0107-01, software versions: v3, v4, v5, and v6
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 circuits
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 circuits
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 21-7323-24, 7) REF 21-7324-24, 8) REF 21-7333-24, 9) REF 21-7336-24, 10) REF 21-7339-24, 11) REF 21-7343-24, 12) REF 21-7349-24, 13) REF 21-7359-24, 14) REF 21-7383-24, 15) REF 21-7390-24, 16) REF 21-7391-24, 17) REF 21-7394-24, 18) REF 21-7395-24, 19) REF 21-7301-24JP, 20) REF 21-7302-24JP, 21) REF 21-7321-24JP, 22) REF 21-7322-24JP, 2
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 21-7310-24, 7) REF 21-7322-24, 8) REF 21-7323-24, 9) REF 21-7324-24, 10) REF 21-7333-24, 11) REF 21-7343-24, 12) REF 21-7346-24, 13) REF 21-7349-24, 14) REF 21-7359-24, 15) REF 21-7363-24, 16) REF 21-7383-24, 17) REF 21-7391-24, 18) REF 21-7394-24, 19) REF 21-7600-24, 20) REF 21-7609-24, 21) REF 21-7624-24, 22) REF 21-7649-24, 23) REF
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 21-7609-24JP, g) REF 21-7624-24JP, h) REF 21-7649-24JP Computerized Ambulatory Delivery Device
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. Computerized Ambulatory Delivery Device
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 a clinical treatment environment. Used for infusion of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions, and other therapeutic fluids.
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, 3500-414, 3500-415, 3500-500, 3500BC, 3500E, 3500G, 3500SD, 3500SD-500, 3500VX, 3500VX-306, 3500VX-414, 3500VX-415, 3500VX-500, 3500ZE, Software Versions 6.0.0, 6.0.1
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 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
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 which a main board was replaced using replacement main board part numbers G6000361, G6000435, G6001260, G6001560, G6001562 and G6002728.
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. 089-101E h. 888-101NE i. 081-102GEE j. 888-101BE k. 888-101GE l. 888-101GEE m. 081-101RE n. 081-102GE o. 081-102BE p. 888-101RE
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. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-13L h. 21-2120-0105-14L i. 21-2120-0105-15L j. 21-2120-0105-17L k. 21-2120-0105-50L l. 21-2127-0105-02L m. 21-2127-0105-06L n. 21-2127-0105-50L
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

Smiths Medical Asd, Inc. carries an outsized archive share

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Cardinal Health 200, LLC 285 Philips Medical Systems (Cleveland) Inc 315 Cook Inc. 264 The Anspach Effort, Inc. 261

Frequently Asked Questions

How many federal recall notices name Smiths Medical Asd, Inc.? ▼
PlainRecalls indexes 293 distinct federal recall events naming Smiths Medical Asd, Inc., aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Smiths Medical Asd, Inc. sit among other recalling firms? ▼
Smiths Medical Asd, Inc. ranks #37 of 14,151 by distinct recall-event count among 14,151 firms in this archive (99th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Smiths Medical Asd, Inc.'s notices? ▼
FDA Devices accounts for 293 of this firm's 293 indexed notices.
What product category dominates Smiths Medical Asd, Inc.'s filing book? ▼
Filings for Smiths Medical Asd, Inc. span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Smiths Medical Asd, Inc.: 293 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Smiths Medical Asd, Inc.; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026