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 43 entries, severity tagging shows 2 critical, 41 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 43 of 43 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 (43). The date window on this page runs from Jul 18, 2012 to May 28, 2014.

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 May 28, 2014

SW-2008 Snuggle Warm Sterile Cardiac Connective Warming Blanket; used with the Equator Convective Warmer, are intended for thermal regulation of a p…

FDA Devices Moderate Apr 16, 2014

Smiths Medical HOTLINE¿ Fluid Warming Set L-80. Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic…

FDA Devices Moderate Apr 16, 2014

Smiths Medical HOTLINE¿ Fluid Warming Set L-70. Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic t…

FDA Devices Moderate Mar 19, 2014

4042LH: 3 mL Line Draw, Luer lock syringe (heparin concentration: 7 I.U. per mL)with Filter-Pro¿ device Arterial Blood Sampling Line Draw Syrin…

FDA Devices Moderate Mar 19, 2014

4042-2: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device Arterial Blood Sampling Line Draw Syr…

FDA Devices Moderate Mar 19, 2014

G1777: Umbilical (2) 3 mL Line Draw, Luer lock syringes (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ devices and (2) Needle-Pro¿ Devic…

FDA Devices Moderate Mar 19, 2014

G2001: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device, Needle-Pro¿ Device and 23G x 1 needle …

FDA Devices Moderate Mar 19, 2014

4043G-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device and ice bag Arterial Blood Sampling …

FDA Devices Moderate Mar 19, 2014

4043E: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device (for sale in Europe only) Arterial Bloo…

FDA Devices Moderate Mar 19, 2014

4042E: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device (for sale in Europe only) Arterial Blo…

FDA Devices Moderate Mar 19, 2014

G1762: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device, syringe tip cap, and 5 mL Luer lock syrin…

FDA Devices Moderate Mar 19, 2014

G1725: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device and 1 mL Line Draw Luer slip syringe (hepa…

FDA Devices Moderate Mar 19, 2014

G1469J: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device (for sale in Japan only) Arterial Blo…

FDA Devices Moderate Mar 19, 2014

4040-2: Umbilical 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device, 22g x 1¿ needle, and Point-Lok…

FDA Devices Moderate Mar 19, 2014

4043W-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device, syringe tip cap and 6 mL Luer slip syri…

FDA Devices Moderate Mar 19, 2014

4043-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device Arterial Blood Sampling Line Draw Syr…

FDA Devices Moderate Jan 15, 2014

Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 0.5ml 29g x 1/2 in Reference: 4429-5 Hypodermic Needle-Pro¿ Fixed Need…

FDA Devices Moderate Jan 15, 2014

Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 0.3ml 29g x 1/2 in Reference: 4429-3 Hypodermic Needle-Pro¿ Fixed Need…

FDA Devices Moderate Jan 15, 2014

Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 1.0ml 29g x 1/2 in Reference: 4429-1 Hypodermic Needle-Pro¿ Fixed Need…

FDA Devices Moderate Jan 15, 2014

Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 1.0ml 29g x 1/2 in Distributed by: Cardinal Health, Dublin, OH (Co-Brand…

FDA Devices Moderate Jan 15, 2014

Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 0.5ml 29g x 1/2 in. Distributed by: Cardinal Health, Dublin, OH (Co-Bran…

FDA Devices Moderate Dec 25, 2013

Medfusion¿ 4000 Syringe Infusion Pumps Medfusion¿ 4000 Syringe Infusion Pumps are designed for use in care areas for the administration of fluids …

FDA Devices Moderate Nov 13, 2013

Portex¿ Spinal Tray with Drugs 25g Whitacre; 15545C-21 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indica…

FDA Devices Moderate Nov 13, 2013

Portex¿ Saddleblock Tray with Drugs  25g Quincke; 4795-20 The Regional Anesthesia family of products is comprised of sterile (unless otherwise in…

FDA Devices Moderate Nov 13, 2013

Portex¿ Spinal Tray with Drugs 25g Whitacre; 15597-20 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicat…

FDA Devices Moderate Nov 13, 2013

Portex¿ Saddleblock Tray with Drugs 22g Quincke (Without Introducer); 4792-20 The Regional Anesthesia family of products is comprised of sterile …

FDA Devices Moderate Nov 13, 2013

Portex¿ Spinal Tray with Drugs 25g Whitacre; 15597C-20 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indica…

FDA Devices Moderate Nov 13, 2013

Portex¿ Spinal Tray with Drugs 22g Whitacre/25g Whitacre; 15248C-22/25 The Regional Anesthesia family of products is comprised of sterile (unless…

FDA Devices Moderate Nov 13, 2013

Portex¿ Spinal Tray with Drugs 22g/25g Quincke; 15249-21 The Regional Anesthesia family of products is comprised of sterile (unless otherwise ind…

FDA Devices Moderate Nov 13, 2013

Portex¿ Saddleblock Tray with Drugs 26g Quincke, 4745-20 The Regional Anesthesia family of products is comprised of sterile (unless otherwise ind…

FDA Devices Moderate Nov 13, 2013

Portex¿ Regional Anesthesia Tray with Drugs; 15548-20 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicat…

FDA Devices Moderate Oct 2, 2013

Smith Medical, Deltec, REF 21-2386-24, 11 Fr Introducer Set with Peel-Away Sheath, Sterile EO, Rx Only PORT-A-CATH¿ and PORT-A-CATH¿ II implantab…

FDA Devices Moderate Oct 2, 2013

Smiths Medical, Deltec: REF 21-8011-24 Port-A-Cath Dual-Lumen. Titanium Venous Access System. REF 21-8052-24 & REF 21-8053-24 , Port-A-Cath II Du…

FDA Devices Moderate May 15, 2013

Wallace Sure-Pro¿ Two Stage Embryo Replacement Catheter for difficult transfer with Stylet PPS623 Sure-Pro¿ Embryo Replacement Catheters are used…

FDA Devices Moderate May 15, 2013

Wallace Sure-Pro Ultra¿ Embryo Replacement Catheter with Obturator Product Code: PEB623 Sure-Pro¿ Embryo Replacement Catheters are used for the i…

FDA Devices Moderate May 15, 2013

Wallace Sure-Pro/ Sure-Pro Ultra Embryo Replacement Catheters (with ultrasound) Product Code: PE623 Sure-Pro¿ Embryo Replacement Catheters are u…

FDA Devices Moderate May 15, 2013

Wallace Sure-Pro¿ Single Stage Embryo Replacement Catheter Product Code: PP623 Sure-Pro¿ Embryo Replacement Catheters are used for the introduct…

FDA Devices Moderate May 15, 2013

Wallace Sure-Pro¿ Two Stage Embryo Replacement Catheter with Obturator PPB623 Sure-Pro¿ Embryo Replacement Catheters are used for the introducti…

FDA Devices Moderate May 15, 2013

Wallace Sure-Pro Ultra¿ Embryo Replacement Catheter with Stylet Product Code:PES623 Sure-Pro¿ Embryo Replacement Catheters are used for the intro…

FDA Devices Critical Apr 10, 2013

Smiths Medical, BCI¿ Remote Alarm Cable (Normally Open & Normally Closed), Reorder Numbers: WW3398NO & WW3398NC. For use with respiration carbon dio…

FDA Devices Moderate Apr 3, 2013

Medfusion Model 3500 Syringe Pump, Model #3500-415 and 3500-500. Intended for use in critical care areas for the administration of fluids requirin…

FDA Devices Critical Aug 8, 2012

Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50…

FDA Devices Moderate Jul 18, 2012

Smiths Medical HOTLINE 3 Blood and Fluid Warmer, Reorder Numbers: HL-390 Product Usage: The Micro-switch is used on the HOTLINE¿ 3 Blood and Flu…

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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.