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 6 critical, 43 moderate, and 1 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 Oct 10, 2018 to Oct 20, 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 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 Moderate Oct 20, 2021

smiths medical medex CBSS 5 ml, Antishunt proximaler Entnahmeport 60 cm, Model Number DPSHC0081

FDA Devices Moderate Oct 20, 2021

smiths medical medex CBSS 5 ml, zweifach proximaler Entnahmeport 60 cm, Model Number DPSHC0084

FDA Devices Moderate Oct 20, 2021

smiths medical medex CBSS 5 ml, einfach proximaler Entnahmeport 60 cm, Model Number DPSHC0083

FDA Devices Moderate Oct 20, 2021

smiths medical medex CBSS-5ML Antishunt set, (172/15cm), Model Number DPSHC0091

FDA Devices Moderate Oct 20, 2021

smiths medical medex HemoDraw Plus Closed Blood Sampling Set with LogiCal Pressure Monitoring System, Model Numbers: a) MX961H182P1 b) MX961H212P1 c)…

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 Moderate Jul 7, 2021

PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit, REF 100/596/090 - Product Usage: intended for use in a controlled setting such as an Intensi…

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 May 5, 2021

Palm Cups - Product Usage: intended to be used to percuss the chest wall to mobilize the secretions within the bronchial tree.

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 Apr 28, 2021

ANGIOGRAPHIC KIT W/MX123-3MR MANIFOLD, Model Number MX1030. for use during angiography and other special procedures.

FDA Devices Moderate Apr 28, 2021

Mark 910 LogiCal, Model Number DPS567201. for blood pressure monitoring and blood sampling.

FDA Devices Moderate Mar 3, 2021

Tube Tracheostomy and Tube Cuff, Bivona¿ Cuffless Neonatal/Pediatric FlexTend" Tracheostomy Tube (model 60PFS45, lots 3991171, 3991172, and 3988103) …

FDA Devices Moderate Jan 27, 2021

Portex Acapella DH Vibratory PEP Device - Product Usage: a single patient use device that provides Positive Expiratory Pressure (PEP) Therapy for pat…

FDA Devices Moderate Jan 6, 2021

PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, REF 60PFSS45

FDA Devices Moderate Sep 16, 2020

Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to provide direct airway access for a tracheotomized patient for up to 29 …

FDA Devices Critical Aug 12, 2020

Medfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1

FDA Devices Critical Aug 12, 2020

Medfusion Syringe Pump Model 3500, Software Version V6.0. Infusion pump.

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 May 6, 2020

Portex Lumbar Puncture Tray. Anesthesia Conduction Kit. 4826PL-20 - Product Usage: Portex lumbar puncture trays provide all the materials necessary t…

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 Critical Dec 18, 2019

Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of de…

FDA Devices Moderate Nov 20, 2019

ProtectIV¿ Plus Safety IV Catheter, sterile. Packaged in a pouch and than into an inner carton.

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 May 1, 2019

Jelco(R) ViaValve(TM) safety intravenous (I.V.) catheters, 18G x 1 1/4", Model Number REF 3265, MOD 10 The Jelco(R) ViaValve(TM) safety I.V. cath…

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 Moderate Dec 5, 2018

Medex High Pressure Stopcock used to control the direction of IV fluid flow. This device is intended for single use only and is provided sterile and …

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…

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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.